List Number. Store at 2-8 C. Store at C

Size: px
Start display at page:

Download "List Number. Store at 2-8 C. Store at C"

Transcription

1 E Toxo IgM 9K09-20 B9K /R4 Toxo IgM This package insert must be read carefully prior to use. Package insert instructions must be followed precisely. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. Read Highlighted Changes Revised March, , 2010 Abbott / Printed in Germany / AxSYM Toxo IgM March 2010 Key to symbols used List Number Lot Number For In Vitro Diagnostic Use Expiration Date Store at 2-8 C Index Calibrator Store at C Control Negative, Positive (NEG, POS) Reagent Pack CAUTION: Handle human sourced materials as potentially infectious. Consult instructions for use. (Infection Risk) Reaction Vessels Matrix Cells 0088 Legal Manufacturer Sample Cups Consult instructions for use See REAGENTS section for a full explanation of symbols used in reagent component naming. ABBOTT Diagnostics Division 1

2 NAME Toxoplasma IgM Antibody INTENDED USE The AxSYM Toxo IgM assay is a Microparticle Enzyme Immunoassay (MEIA) for the measurement of IgM antibodies to Toxoplasma gondii in human serum or plasma (EDTA, heparin or sodium citrate) to aid in the diagnosis of primary infection. The AxSYM Toxo IgM assay is not for use with cord blood or neonatal specimens. SUMMARY AND EXPLANATION OF THE TEST Toxoplasma gondii is an obligate intracellular parasite capable of infecting a wide variety of intermediate hosts including man (see reference 1 for a comprehensive review of toxoplasmosis). Infected definitive hosts (cats) shed oocysts in feces which rapidly mature in soil and become infectious. When ingested by intermediate hosts, tachyzoites form and multiply rapidly with eventual development of cysts containing the slower growing, but infectious bradyzoites. Thus, toxoplasmosis is acquired by man via ingestion of cat feces or undercooked meats infested with cysts. 2,3 Infection of the normal adult is commonly asymptomatic. In those cases with clinical manifestations, the most common of the symptoms is lymphadenopathy which may be accompanied by an array of other symptoms making differential diagnosis difficult. 4,5 On the other hand, severe to fatal infections do occur in adults immunocompromised by cancer chemotherapy or immunosuppressive treatment and in patients with AIDS. Infections in the immunocompromised adults are thought to be reactivation of latent acquired infections and usually involve the central nervous system although involvement of other sites has been reported. 6-9 Transplacental transmission of the parasite resulting in congenital toxoplasmosis can occur during the acute acquired maternal infection. The risk of fetal infection is a function of time at which acute maternal infection occurs during gestation. Maternal infections acquired before conception present very little, if any, risk to the fetus. However, the incidence of congenital toxoplasmosis increases as pregnancy progresses; conversely, the severity of congenital toxoplasmosis is greatest when maternal infection is acquired early during pregnancy. A majority of infants infected in utero are asymptomatic at birth, particularly if maternal infection occurs during the third trimester, with sequelae appearing later in life. 10,11 Congenital toxoplasmosis results in severe generalized or neurologic disease in about 20-30% of the infants infected in utero; approximately 10% exhibit ocular involvement only, and the remainder (about 70%) are asymptomatic at birth. 11,12 Subclinical infection may result in premature delivery and subsequent neurologic, intellectual, and audiologic defects. 10,13 Prospective studies of pregnancies have shown that prenatal diagnosis of infection followed by prenatal therapy reduces the frequency and the severity of congenital toxoplasmosis. 10,14 Serologic tests can be used to identify those pregnancies at risk; women who are seronegative at the time of diagnosis of pregnancy can be monitored during pregnancy. Seroconversion is indicative of T. gondii infection and establishes gestational age when maternal infection occurred. 10,14,15 Serologic tests specific for T. gondii IgM antibodies are useful aids in the diagnosis of both congenital and acute acquired toxoplasmosis Levels of IgM antibody increase rapidly following acute acquired infections and begin to decline after several months but can persist at detectable levels for a year or more Since persisting IgM levels may be detected long after the onset of acquired infection, the use of a single serological test result must be used with caution in those cases when it is critical to establish the time of infection. This applies to the diagnosis of acute T. gondii infection acquired during pregnancy. Determination of the date of infection based solely on the results of detectable IgM antibody to T. gondii is not recommended. That determination should include clinical history and previous serology, since low levels of IgM antibody may persist for a year or more The use of a test to determine a rise in IgG antibody to T. gondii may provide additional information as to the date of infection. The AxSYM Toxo IgM assay is a method for the measurement of T. gondii specific antibodies in human serum and plasma (EDTA, heparin or sodium citrate). BIOLOGICAL PRINCIPLES OF THE PROCEDURE The AxSYM Toxo IgM assay is based on the Microparticle Enzyme Immunoassay (MEIA) technology. Sample and all AxSYM Toxo IgM reagents required for one test are pipetted by the Sampling Probe into various wells of a reaction vessel (RV) in the Sampling Center. The RV is immediately transferred into the Processing Center. Further pipetting is done in the Processing Center by the Processing Probe. The reactions occur in the following sequence: SAMPLING CENTER The Sampling Probe dilutes the sample in Solution 4 (Line Diluent) and delivers an aliquot of diluted sample and T. gondii Coated Microparticles to an incubation well of the RV. The T. gondii antibody binds to the T. gondii Coated Microparticles forming an antigen-antibody complex. PROCESSING CENTER Assay Diluent is added to the reaction mixture and an aliquot of the antigen-antibody complex is transferred to the matrix cell. The microparticles bind irreversibly to the glass fiber matrix. The matrix cell is washed with RF Neutralization Buffer to remove RF interference antibodies (if present) from the antigen-antibody complex. The matrix cell is washed to remove unbound materials. The Anti-Human IgM: Alkaline Phosphatase Conjugate is dispensed onto the matrix cell and binds to the antigen-antibody complex. The matrix cell is washed to remove unbound materials. The substrate, 4-Methylumbelliferyl Phosphate, is added to the matrix cell and the fluorescent product is measured by the MEIA optical assembly. For further information regarding MEIA technology, refer to the AxSYM System Operations Manual, Section 3. REAGENTS REAGENT PACK, 100 Tests AxSYM Toxo IgM Reagent Pack (9K09-20) 1 Bottle (7.8 ml) T. gondii Coated Microparticles in Tris buffer with protein stabilizers. Preservatives: Antimicrobial Agents. (Reagent Bottle 1) 1 Bottle (9.5 ml) Anti-Human IgM (goat): Alkaline Phosphatase Conjugate in Tris buffer with protein stabilizers. Minimum concentration: 0.3 μg/ml. Preservative: Sodium Azide. (Reagent Bottle 2) 1 Bottle (25.7 ml) Assay Diluent in Tris buffer with protein stabilizers. Preservatives: Antimicrobial Agents. (Reagent Bottle 3) 1 Bottle (26.0 ml) RF Neutralization Buffer, Citrate. Preservatives: Antimicrobial Agents. (Reagent Bottle 4) CALIBRATOR AxSYM Toxo IgM Index Calibrator (9K09-40) 1 Bottle (3 ml) AxSYM Toxo IgM Index Calibrator prepared with recalcified human plasma reactive for T. gondii IgM Ab and nonreactive for HBsAg, HIV-1 Ag or HIV-1 NAT, anti-hcv and anti-hiv-1/hiv-2. Preservative: Sodium Azide CONTROLS AxSYM Toxo IgM Controls (9K09-10) 1 Bottle (5 ml) AxSYM Toxo IgM Negative Control prepared with recalcified human plasma nonreactive for HBsAg, HIV-1 Ag or HIV-1 NAT, anti-hcv, anti-hiv-1/hiv-2 and T. gondii IgM Ab. 1 Bottle (5 ml) AxSYM Toxo IgM Positive Control prepared with recalcified human plasma reactive for T. gondii IgM Ab and nonreactive for HBsAg, HIV-1 Ag or HIV-1 NAT, anti-hcv and anti-hiv-1/hiv-2. Bottle Anti-Toxo IgM Index Value Ranges (Index) Preservative: Sodium Azide. 2

3 OTHER REAGENTS Solution 1 (MUP) (8A47-04) 4 Bottles (230 ml each) Solution 1 (MUP) containing 4-Methylumbelliferyl Phosphate, 1.2 mm, in AMP buffer. Preservative: Sodium Azide. Solution 3 (Matrix Cell Wash) (8A81-04) 4 Bottles (1000 ml each) Solution 3 (Matrix Cell Wash) containing 0.3 M Sodium Chloride in 0.05 M Tris buffer. Preservatives: Sodium Azide and Antimicrobial Agents. Solution 4 (Line Diluent) (8A46) 1 Bottle (10 L) Solution 4 (Line Diluent) containing 0.1 M Phosphate buffer. Preservatives: Sodium Azide and Antimicrobial Agents. AxSYM Probe Cleaning Solution (9A35-05/9A35-04) 2 Bottles (220 ml each) AxSYM Probe Cleaning Solution. Contains 2% Tetraethylammoniumhydroxide (TEAH). WARNINGS AND PRECAUTIONS For In Vitro Diagnostic Use. SAFETY PRECAUTIONS CAUTION: This product contains human sourced and/or potentially infectious components. For a specific listing, refer to the REAGENTS section of this package insert. Components sourced from human blood have been tested and found to be nonreactive for HBsAg, HIV-1 Ag or HIV-1 NAT, anti-hcv and anti-hiv-1/hiv-2. No known test method can offer complete assurance that products derived from human sources or inactivated microorganisms will not transmit infection. Therefore, all human sourced materials should be considered potentially infectious. It is recommended that these reagents and human specimens be handled in accordance with the OSHA Standard on Bloodborne Pathogens. 22 Biosafety Level 2 23 or other appropriate biosafety practices 24, 25 should be used for materials that contain or are suspected of containing infectious agents. The AxSYM Probe Cleaning Solution (2% TEAH) may cause mild eye irritation. If this solution comes in contact with eyes, rinse immediately with water. If irritation persists, seek medical advice. Some components of this product contain Sodium Azide. For a specific listing, refer to the REAGENTS section of this package insert. The components containing Sodium Azide are classified per applicable European Community (EC) Directives as: Harmful (Xn). The following are the appropriate Risk (R) and Safety (S) phrases. R22 Harmful if swallowed. R32 Contact with acids liberates very toxic gas. S35 This material and its container must be disposed of in a safe way. S36 Wear suitable protective clothing. S46 If swallowed, seek medical advice immediately and show this container or label. Information for European Customers: For product not classified as dangerous per European Directive 1999/45/EC - safety data sheet available for professional users on request. HANDLING PRECAUTIONS Do not use Solution 1 (MUP) beyond expiration date or a maximum of 14 days on-board the AxSYM System. When loading new Solution 1 (MUP) it is important to immediately tighten the instrument cap for MUP to minimize exposure to air. Prolonged exposure of MUP to air may compromise performance. Do not use Reagent Pack beyond the expiration date or a maximum of 336 cumulative hours on-board the AxSYM System. Do not mix reagents from different reagent packs. Additional safety and handling precautions and limitations for the Reagent Packs, Index Calibrator, Controls, patient samples and other reagents are described in the AxSYM System Operations Manual, Sections 7 and 8. STORAGE INSTRUCTIONS The AxSYM Toxo IgM Reagent Pack, Index Calibrator and Controls must be stored at 2-8 C. The AxSYM Toxo IgM Reagent Pack, Index Calibrator, and Controls may be used immediately after removing them from the refrigerator. Index Calibrator and Controls should be returned to 2-8 C storage immediately after use. Do not freeze the AxSYM Toxo IgM Reagents. The AxSYM Toxo IgM Reagent Pack may be on-board the AxSYM System for a maximum of 336 cumulative hours; for example 42 eight hour shifts. Recalibration may be required to obtain maximum on-board reagent stability. More frequent use of controls may be required to monitor reagent performance within the same lot. Refer to the AxSYM System Operations Manual, Sections 2, 5 and Appendices, for further information on tracking on-board time. Solution 1 (MUP) must be stored at 2-8 C. It may be on-board the AxSYM System for a maximum of 14 days. After 14 days, it must be discarded. It may be used immediately after removing it from the refrigerator. Do not freeze MUP. The AxSYM Probe Cleaning Solution, Solution 3 (Matrix Cell Wash) and Solution 4 (Line Diluent) must be stored at C. INSTRUMENT PROCEDURE Assay File Installation The AxSYM Toxo IgM Assay File must be installed on the AxSYM System from one of the following software disks, prior to performing Toxo IgM assays: 8B96-02 (112 hours on-board Stability) 7D16-01, or higher (336 hours on-board Stability) Refer to the AxSYM System Operations Manual, Section 2 for proper installation procedures. AxSYM Toxo IgM Assay Parameters The default values for the assay parameters used for the AxSYM Toxo IgM assay are listed below. Assay parameters that can be edited contain a (>) symbol. These parameters can be displayed and edited according to the procedure in the AxSYM System Operations Manual, Section 2. In order to obtain values for the parameters with an asterisk (*), review the specific Assay Parameter screen. Press PRINT to print the assay parameters. Assay Parameters 1 Long assay name (English): TOXO_M 6 Abbrev Assay Name (English): TOXO_M 11 Assay Number: Assay Version: * 13 Calibration Version: * 14 Assay File Revision: * 15 Assay Enabled > ON 17 Assay Type: MEIA 18 Standard Cal Reps > 2 19 Master Cal Reps: 0 20 Cal Adjust Reps: 0 21 Cal A Concentration: Cal B Concentration: Cal C Concentration: Cal D Concentration: Cal E Concentration: Cal F Concentration: Master Calibrator 1 Concentration: Master Calibrator 2 Concentration: Cal Adjustment Concentration: Default Dilution Protocol > UNDILUTED 44 Default Calibration Method > Index Cal 45 Selected Result Concentration Units > Index 46 Selected Results Decimal Places > 3 62 Blank I - Max background intensity: Min Tracer-Min net intensity: Max Intercept-Max MUP intercept:

4 Assay Parameters 65 Min Intercept-Min MUP intercept: Upper limit for NRMSE for low rates: Upper limit for NRMSE for high rates: Max Rate-Max rate used to check Min MUP Intercept: Min Rate-Rate cutoff for NRMSE and Corr. Coef.: Min correlation coefficient for low rates: Min correlation coefficient for high rates: MUP T Delay-Time delay following MUP: Low Limit-Normal/Therapeutic Range lower limit > High Limit-Normal/Therapeutic Range upper limit > Low Extreme Value > High Extreme Value > Lo Norm-% Uptake Normal Range Low > Hi Norm-% Uptake Normal Range High > Interpretation Option to use > 1 84 Hold results with POS interpretation > OFF 85 Hold results with NEG interpretation > OFF 86 Hold results with GRY interpretation > OFF 91 Low range Undiluted: High range Undiluted: Low Range Dil1: High Range Dil1: Low Range Dil2: High Range Dil2: Low Range Dil3: High Range Dil3: Max End-Point Deviation: Max Baseline Intensity: Min Baseline Intensity: Max Percent Transmission: NOTE: Parameters 43, 44, 45, and 46 cannot be edited. Refer to the AxSYM System Operations Manual for a detailed description of Instrument Procedures. For details on Automatic Sample Retest Configuration, refer to the AxSYM System Operations Manual, Section 2. SAMPLE COLLECTION AND PREPARATION FOR ANALYSIS Serum or plasma (EDTA, heparin or sodium citrate) may be used in the AxSYM Toxo IgM assay. Follow the manufacturer s processing instructions for serum or plasma collection tubes. Samples may stored for up to 7 days at 2-8 C after the date of collection. If testing will be delayed more than 7 days, the specimens should be stored at -10 C or colder. Mix after thawing to insure consistency in results and centrifuge at > 10,000 x g for 10 minutes before testing. This assay has not been validated for specimens which have undergone more than five freeze/thaw cycles. Specimens should be free of fibrin, red blood cells, or other particulate matter. Specimens showing particulate matter, erythrocytes or turbidity must be clarified by centrifugation at > 10,000 x g for 10 minutes before testing. Heat treated specimens, lipemic specimens, grossly hemolyzed specimens, or specimens with obvious microbial contamination should not be tested with this procedure. When shipped, samples must be packaged and labeled in compliance with applicable federal and international regulations covering the transport of clinical samples and etiologic agents. The AxSYM System does not provide the capability of verifying sample type. It is the responsibility of the operator to verify the correct sample type(s) is (are) used in the AxSYM Toxo IgM assay. All samples (patient samples, controls and calibrators) should be tested within 3 hours of being placed on-board the AxSYM System. Refer to the AxSYM System Operations Manual, Section 5, for more detailed discussion of on-board sample storage constraints. Inspect all samples for bubbles. Remove all bubbles prior to analysis. SAMPLE VOLUME The sample volume required to perform a single Toxo IgM test on the AxSYM System varies depending on the type of sample container used. For sample cups, a ROUTINE test requires 150 μl and a STAT test requires 83 μl. For every additional Toxo IgM test performed (ROUTINE or STAT) from the same container, an additional 33 μl of sample is required. The sample cup minimum volumes for both STAT and ROUTINE tests are calculated by the AxSYM System. They are displayed on the Order screen at the time the test(s) is (are) ordered. When using Host Order Query, the Order screen information and Orderlist Report are not available. Refer to the AxSYM System Operations Manual, Section 5: Ordering Patient Samples, for a description of the Host Order Query option. If the assay is configured for Auto Retest the additional sample volume needed for the retest will not be displayed on the Order screen at the time the test(s) is (are) ordered. Therefore the total sample volume should include the additional 33 μl of sample. Refer to the AxSYM System Operations Manual, Section 2, for details on Automatic Sample Retest Configuration. To obtain the recommended volume requirements for AxSYM Toxo IgM Index Calibrator and Controls, hold the bottles vertically and dispense 4 drops of Index Calibrator or 4 drops of Positive or Negative Control into each respective sample cup. For sample volume requirements in primary or aliquot tubes and Control volume requirements for multiple AxSYM Toxo IgM reagent lots, refer to the AxSYM System Operations Manual, Section 5. AxSYM Toxo IgM PROCEDURE Materials Required 9K09-20 AxSYM Toxo IgM 8A A AxSYM System 9K09-40 AxSYM Toxo IgM Index Calibrator 9K09-10 AxSYM Toxo IgM Controls 8A A A46 9A35-05/ AxSYM 9A A76-01 Materials Required But Not Provided Pipettes and pipette tips CAUTION: When manually dispensing samples into sample cups, verify that dispensing equipment does not introduce cross contamination and delivers the specified sample volume. For optimal performance, it is important to follow the routine maintenance procedures defined in the AxSYM System Operations Manual, Section 9. If your laboratory requires more frequent maintenance, follow those procedures. Assay Procedure Sections 5 and 6 of the AxSYM System Operations Manual contain detailed steps for performing assay calibration and sample testing procedures. Prior to ordering tests, confirm that System Inventory of matrix cells, bulk solutions and waste levels are acceptable. The Orderlist Report contains sample placement information and sample cup volume requirements for all ordered tests. It is recommended that this report be referenced when loading samples into sample segments. When using Host Order Query, the Order screen information and Orderlist Report are not available. Refer to the AxSYM System Operations Manual, Section 5: Ordering Patient Samples, for a description of the Host Order Query option. 4

5 CAUTION: When operating the AxSYM System, always observe the following: The System status must be WARMING, PAUSED, READY, or STOPPED before adding or removing sample segments, reagent packs, or reaction vessels. Do not open the Interior Waste Door or the Processing Center Cover while any test is in progress. If opened, all processing will stop. All tests will be terminated and must be repeated. When testing is completed, it is recommended that samples and the AxSYM Toxo IgM Reagent Pack are removed from the Sampling Center to maximize the on-board reagent pack use. Store at 2-8 C. QUALITY CONTROL PROCEDURES CALIBRATION The AxSYM Toxo IgM Assay must be calibrated by testing 2 replicates of the Index Calibrator. Dispense 4 drops of the Index Calibrator into a sample cup. A single sample of the AxSYM Toxo IgM controls must be tested as a means of evaluating the assay calibration. Once an AxSYM Toxo IgM Calibration is accepted and stored, all subsequent samples may be tested without further calibration unless: A reagent pack with a new lot number is used Control values are out of their specified range Refer to the AxSYM System Operations Manual, Section 6, for: Setting up an assay calibration When recalibration may be necessary Calibration verification The AxSYM System verifies that the results of an assay calibration meet the specifications assigned to selected validity parameters. An error message occurs when the calibration fails to meet a specification. Refer to the AxSYM System Operations Manual, Section 10 for an explanation of the corrective actions for the error code. Refer to the AxSYM System Operations Manual, Appendices, for an explanation of the calibration validity parameters that may be used by the AxSYM System. QUALITY CONTROL The recommended control requirement for the AxSYM Toxo IgM assay is a single sample of each of the Positive and Negative Controls tested once every 8 hours, each day of use. Controls may be placed in any position in the sample carousel. If quality control procedures in your laboratory require more frequent use of controls to verify test results, follow those procedures. To achieve maximum on-board reagent stability, more frequent use of controls may be required to monitor reagent performance within the same lot. Ensure that AxSYM Toxo IgM Control values are within the acceptable ranges specified in the package insert. Refer to REAGENTS, CONTROLS section of this package insert. INDICATIONS OF INSTABILITY OR DETERIORATION OF REAGENTS When an AxSYM Toxo IgM Positive or Negative Control value is out of the expected range, it may indicate deterioration of the reagents or errors in technique. Associated test results should be considered invalid and require retesting. Assay recalibration may be indicated. Refer to the AxSYM System Operations Manual, Section 10, for further troubleshooting information. The AxSYM System has a capability to generate a Levey-Jennings plot of each assay s quality control performance. Refer to the AxSYM System Operations Manual, Section 5. At the discretion of the laboratory, selected quality control rules may be applied to the quality control data. Fluorescence Background Acceptance Criteria Quality control of the MUP substrate blank is automatically determined by the instrument and checked under Assay Parameter 64 (Max Intercept- Max MUP Intercept) each time a test result is calculated. If the MUP Intercept value is greater than the maximum allowable value, the result is invalid. The test request will be moved to the Exceptions List where it will appear with the message 1064 Invalid test result, intercept too high and the calculated intercept value. Refer to the AxSYM System Operations Manual, Section 10, when this error message is obtained. Refer to the AxSYM System Operations Manual, Section 2, for further information on this parameter. RESULTS CALCULATION The AxSYM System calculates a Toxo IgM Index Value based on the ratio of the sample (patient/control) rate to the Index Calibrator Mean Rate. Sample Rate Index Value = Index Calibrator Mean Rate FLAGS Some results may contain information in the Flags field. For a description of the flags that may appear in this field, refer to the AxSYM System Operations Manual, Sections 1 and 2. INTERPRETATION OF THE RESULTS Samples with Index Values less than or equal to are considered nonreactive for IgM antibody to T. gondii by the criteria of AxSYM Toxo IgM. Samples with Index Values in the range of to are considered equivocal (grayzone). Samples interpreted as equivocal (grayzone) may contain very low levels of IgM. A second specimen should be obtained and tested. Samples with Index Values equal to or greater than are considered reactive for IgM antibody to T. gondii by the criteria of AxSYM Toxo IgM. LIMITATIONS OF THE PROCEDURE The use of the AxSYM Toxo IgM Antibody assay to diagnose recent infection by testing paired sera has not been validated. Performance has not been established for cord blood, neonatal samples, or body fluids such as urine, saliva, semen, amniotic fluid or cerebrospinal fluid. Negative results by this test do not preclude recent primary T. gondii infection. IgM type rheumatoid factor in the presence of T. gondii specific IgG can interfere in IgM class assays, causing false positives results. The RF neutralization buffer is provided to minimize such interference, however, high levels of IgG and RF could cause false positive results. The level of anti-t. gondii IgG inhibited by the RF neutralizing buffer has not been determined. If the AxSYM Toxo IgM assay is used as a general screen in the absence of clinical symptoms or known exposure, a diagnosis of an unsuspected primary T. gondii infection should not be based solely upon a positive result. Another method should be used for confirmation before making that diagnosis. Epstein-Barr Virus (EBV) is known to be a potent B-Cell stimulator. 26 Infections with EBV have been suspected to elicit antigen-specific IgM responses in individuals previously sensitized to a variety of non- EBV infectious agents. 27,28 Specimens showing particulate matter, erythrocytes, or turbidity must be clarified by centrifugation at > 10,000 x g for 10 minutes before testing. Heat-treated serum, lipemic serum, grossly hemolyzed serum, or serum with obvious microbial contamination should not be tested with this procedure. EXPECTED RESULTS The prevalence of IgM antibody to T. gondii in a population will vary with age and geographic location. In this study 800 specimens from pregnant women and 500 specimens from random low risk individuals in Europe and the U.S. were tested. Of these specimens, 88 (6.8%) were positive, 15 (1.1%) were equivocal, and 1,197 (92.1%) were negative by the AxSYM Toxo IgM Antibody assay. The distribution for this population is shown in Figure 1. 5

6 SPECIFIC PERFORMANCE CHARACTERISTICS PRECISION Assay reproducibility was determined as described in National Committee for Clinical Laboratory Standards (NCCLS) Protocol EP5-T2. 29 A twelve member panel of serum and plasma, as well as a Negative Control and Positive Control were assayed at 3 laboratories (Site I, II and III) in replicates of 2 at two separate times per day for twenty days (N= 80 for each panel and Control) using a single lot of reagents and a single calibration. The two runs assayed per day were separated by a minimum of two hours. The within run and total reproducibilities were evaluated by calculating the standard deviation (SD) and coefficient of variation (%CV) of each panel member and Control. The results of the reproducibility study are summarized in Table 1 of this section and show that acceptable reproducibility results were obtained for Negative and Positive Controls and all panel members. Table 1 REPRODUCIBILITY FOR AxSYM TOXO IgM ANTIBODY ASSAY Negative Control I II III Positive Control I II III Panel Member 1 (serum) I II III Panel Member 2 (serum) I II III Panel Member 3 (serum) I II III Panel Member 4 (EDTA) I II III Panel Member 5 (EDTA) I II III Panel Member 6 (EDTA) I II III Panel Member 7 (sodium citrate) I II III Panel Member 8 (sodium citrate) I II III Panel Member 9 (sodium citrate) I II III Panel Member 10 (heparin) I II III Panel Member 11 (heparin) I II III Panel Member 12 (heparin) I II III

7 RELATIVE AGREEMENT The presence of IgM antibody to Toxoplasma gondii in 1,363 specimens was determined by 2 U.S. (Site I and II) and 1 European laboratory (Site IV) using the AxSYM Toxo IgM Antibody assay. In addition, each specimen was tested using a legally marketed EIA. The relative agreement was calculated to be 99.3% (Exact 95% confidence interval: 98.8% to 99.7%) (1354/1363). RELATIVE SENSITIVITY Of the 1,363 specimens tested, 182 were found to be positive by EIA. Of these 182, 156 were positive, 20 were equivocal, and 6 were negative by AxSYM Toxo IgM Antibody assay for a relative sensitivity of 96.3% (Exact 95% confidence interval: 92.1% to 98.6%) (156/162). RELATIVE SPECIFICITY Of the 1,363 specimens tested, 1,209 were found to be negative by EIA. Of these 1,209, 1,198 were negative, 8 were equivocal, and 3 were positive by AxSYM Toxo IgM Antibody assay for a relative specificity of 99.8% (Exact 95% confidence interval: 99.3% to 100%) (1198/1201). NOTE: Specimens giving equivocal results using AxSYM and/or EIA were not included in the calculation of relative agreement, relative sensitivity and relative specificity. Table 2 Comparison of AxSYM Toxo IgM with EIA Site I Site II Site IV Total Relative 99.4% 98.5% 99.7% 99.3% Agreement (338/340) (333/338) (683/685) (1354/1363) Relative 94.4% 94.6% 97.8% 96.3% Sensitivity (34/36) (35/37) (87/89) (156/162) Relative 100% 99.0% 100% 99.8% Specificity (304/304) (298/301) (596/596) (1198/1201) AxSYM 2.3% 3.1% 1.9% 2.3% Equivocal (8/350) (11/350) (13/700) (32/1400) Site IV tested multiple bleeds from 30 patients demonstrating seroconversion to T. gondii. For 21 seroconversion patients whose series contained a positive IgG bleed drawn no longer than 8 weeks following the last negative bleed, evaluation of IgG and IgM antibody response was performed. The first specimen in the series which gave a positive result by the Sabin-Feldman Dye test was also positive by AxSYM Toxo IgM Antibody assay in all 21 cases. The specificity of the AxSYM Toxo IgM assay was further evaluated by testing 201 specimens positive for anti-nuclear antibody, systemic lupus erythematosus, rheumatoid factor, herpes simplex virus, Epstein-Barr virus, measles, parvovirus, varicella zoster virus, hyper IgG, hyper IgM, and influenza vaccine recipients. With these specimens, AxSYM Toxo IgM and the EIA showed 98% agreement (197/201). Additional studies were performed to evaluate the effect of endogenous substances that may be present in clinical specimens. The following compounds did not show interference in the AxSYM Toxo IgM assay at the levels indicated: 1000 mg/dl hemoglobin, 20 mg/dl bilirubin, 2000 mg/dl triglycerides, 10 g/dl protein, or 0.4% red blood cells. BIBLIOGRAPHY 1. Remington JS, Desmonts G. Toxoplasmosis. ln: Remington JS, Klein JO, editors. Infectious Diseases of the Fetus and Newborn Infant. Philadelphia: WB Sanders 1983: Wallace GD, Marshall L, Marshal M. Cats, Rats and Toxoplasmosis on a Small Pacific Island. AM J Epidemiol 1972;95: Frenkel JK. Toxoplasma in and Around Us. Bioscience 1973;23: Remington JS. Toxoplasmosis in the Adult. Bull N Y Acad Med 1974;50: Krick JA, Remington JS. Toxoplasmosis In the Adult- An Overview. N Eng J Med 1978;298: Ruskin J, Remington JS Toxoplasmosis in the Compromised Host. Ann Intern Med 1976;84: Mendelson MH, Finkel LJ, Meyers BR, Lieberman JP, Hirschman SZ. Pulmonary Toxoplasmosis in AIDS. Scand J Infect Dis 1987;19: Luft BJ, Remington JS. Toxoplasmosis of the Central Nervous System. Curr Clin Top Infect Dis 1985;6: Luft BJ, Remington JS. Toxoplasmic Encephalitis. J Infect Dis 1988; 157: Desmonts G, Couvreur J. Congenital Toxoplasmosis. A Prospective Study of 378 Pregnancies. N Engl J Med 1974; 290: Desmonts G, Couvreur J. Toxoplasmosis: Epidemiologic and Serologic Aspects of Prenatal Infection. In: Krugmann S.,Gershon AE, editors. Infections of the Fetus and Newborn Infant. New York: Alan R. Liss, Inc. 1975; Alford CA Jr, Stagno S, Reynolds DW. Toxoplasmosis: Silent Congenital Infect. In: Krugmann S, Gershon AE, editors. Infections of the Fetus and Newborn Infant. New York: Alan R. Liss, Inc. 1975; Wilson BD, Remington JS, Stagno S, Reynolds DW. Development of Adverse Sequelae in Children Born With Subclinical Toxoplasma Infection. Pediatrics 1980;66: Daffos F, Foestier F, Capella-Pavalovsky M Thulliez P, Aufrant C, Valenti D, Cox WL. et al. Prenatal Management of 746 Pregnancies At Risk For Congenital Toxoplasmosis. N Engl J Med 1988;318: McCabe R, Remington JS. Toxoplasmosis: The Time Has Come. N Engl J Med 1988;318: Remington JS, Miller MJ, Brownlee I. IgM Antibodies In Acute Toxoplasmosis: I. Diagnostic Significance In Congenital Cases and a Method for Their Rapid Demonstration. Pediatrics 1968;41: Remington JS, Miller MJ, Brownlee I. IgM Antibodies In Acute Toxoplasmosis: II. Prevalence and Significance In Acquired Cases. J Lab Clin Med 1968;71: Naot Y, Remington JS. An Enzyme-Linked Immunosorbent Assay For The Detection of IgM Antibodies to Toxoplasma gondii: Use for Diagnosis of Acute Acquired Toxoplasmosis. J Infect Dis 1980;142: Naot Y, Guptill DR, Remington JS. Duration of IgM Antibodies to Toxoplasma gondii After Acute Acquired Toxoplasmosis. J Infect Dis 1982;145: Sulzer AJ, Franco EL, Takafuji E, Benenson M, Walls K, Greenup RL. An Oocyst-Transmitted Outbreak of Toxoplasmosis: Patterns of Immunoglobulin G and M Over One Year. Am J Trop Med Hyg 1986;35: Brooks RG, McCabe RE, Remington JS. Role of Serology In the Diagnosis of Toxoplasmic Lymphadenopathy. Rev Infect Dis 1987;9: U.S. Department of Labor, Occupational Safety and Health Administration, 29 CFR Part , Occupational Exposure to Bloodborne Pathogens. 23. U.S. Department of Health and Human Services. Biosafety in Microbiological and Biomedical Laboratories. HHS Publication (CDC) Washington: U.S. Government Printing Office, May World Health Organization. Laboratory Biosafety Manual. Geneva. World Health Organization, National Committee for Clinical Laboratory Standards. Protection of Laboratory Workers from Instrument Biohazards and Infectious Disease Transmitted by Blood, Body Fluids, and Tissue. Approved Guideline. NCCLS Document M29-A2. Wayne, PA: NCCLS, Moller E, Strom H, Al-Balaghi S. Role of Polyclonal Activation in Specific Immune Responses. Relevance for Findings of Antibody Activity in Various Diseases. Scand J Immunol, 1980;12: Rasmussen L, Keisall D, Nelson R, Carney W, Hirsh M, Winston D, et al. Virus-Specific IgG and IgM Antibodies in Normal and Immunocompromised Subjects Infected with Cytomegalovirus. J Infect Dis 1982:145: Morgan-Capner P, Tedder RS, Mace JE. Rubella-Specific IgM Reactivity in Sera from cases of Infectious Mononucleosis. J Hyg (Lond) 1983;90: National Committee for Clinical Laboratory Standards. Evaluation of Precision Performance of Clinical Chemistry Devices - Second Edition; Tentative Guideline. NCCLS Document EP5-T2, March AxSYM is a registered trademark of Abbott Laboratories, Abbott Park, IL, USA. For additional product information, please contact your local customer service organization. 7

Key to symbols used. For In Vitro Diagnostic Use. Store at C

Key to symbols used. For In Vitro Diagnostic Use. Store at C E Rubella IgM 4B46 34-3063/R6 Rubella IgM Customer Service United States: 1-877-4ABBOTT International: Call your Abbott Representative This package insert must be read carefully prior to use. Package insert

More information

Customer Service For additional product information, please contact your local customer service organization. Key to symbols used

Customer Service For additional product information, please contact your local customer service organization. Key to symbols used HAVAB 2.0 en HAVAB 2.0 6C70-20 48-0384/R8 B6C700 Read Highlighted Changes Revised September, 2008 Customer Service For additional product information, please contact your local customer service organization.

More information

Customer Service For additional product information, please contact your local customer service organization. Key to symbols used

Customer Service For additional product information, please contact your local customer service organization. Key to symbols used HAVAB-M 2.0 E HAVAB-M 2.0 6C69-20 84-6811/R7 B6C690 Read Highlighted Changes Revised June, 2008 Customer Service For additional product information, please contact your local customer service organization.

More information

Toxoplasma gondii IgM (Toxo IgM)

Toxoplasma gondii IgM (Toxo IgM) DIAGNOSTIC AUTOMATION, INC. 21250 Califa Street, Suite 102 and116, Woodland Hills, CA 91367 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com

More information

Toxoplasma gondii IgM ELISA Kit

Toxoplasma gondii IgM ELISA Kit Toxoplasma gondii IgM ELISA Kit Catalog Number KA0226 96 assays Version: 02 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Background... 3 Principle

More information

Key to symbols used. List Number. For In Vitro Diagnostic Use. Store at 2-8 C. Store at C Reagent Pack. Consult instructions for use

Key to symbols used. List Number. For In Vitro Diagnostic Use. Store at 2-8 C. Store at C Reagent Pack. Consult instructions for use E 7A56 34-2990/R9 Customer Service United States: 1-877-4ABBOTT International: Call your Abbott Representative This package insert must be read carefully prior to product use. Package insert instructions

More information

Toxoplasma gondii IgM ELISA Kit

Toxoplasma gondii IgM ELISA Kit Toxoplasma gondii IgM ELISA Kit Catalog Number KA0226 96 assays Version: 01 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Background... 3 Principle

More information

IgG Antibodies To Toxoplasma Gondii ELISA Kit Protocol

IgG Antibodies To Toxoplasma Gondii ELISA Kit Protocol IgG Antibodies To Toxoplasma Gondii ELISA Kit Protocol (Cat. No.:EK-310-85) 330 Beach Road, Burlingame CA Tel: 650-558-8898 Fax: 650-558-1686 E-Mail: info@phoenixpeptide.com www.phoenixpeptide.com INTENDED

More information

CHEMILUMINESCENCE ENZYME IMMUNOASSAY (CLIA) Toxoplasma IgG. Cat # (20-25 C Room temp.) Volume

CHEMILUMINESCENCE ENZYME IMMUNOASSAY (CLIA) Toxoplasma IgG. Cat # (20-25 C Room temp.) Volume DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite D/E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external

More information

See external label 2 C-8 C 96 tests Chemiluminescence. CMV IgM. Cat # Diluted samples, controls & calibrator 100 µl 30 minutes

See external label 2 C-8 C 96 tests Chemiluminescence. CMV IgM. Cat # Diluted samples, controls & calibrator 100 µl 30 minutes DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite D/E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external

More information

READ HIGHLIGHTED CHANGES

READ HIGHLIGHTED CHANGES BIO-FLASH Toxo IgM 3000-8554 50 tests The BIO-FLASH Toxo IgM is a fully automated chemiluminescent two-step immunoassay for qualitative measurement of IgM antibodies to Toxoplasma gondii in human serum

More information

Valproic Acid. Valproic Acid 7A /R8. Note Changes Highlighted

Valproic Acid. Valproic Acid 7A /R8. Note Changes Highlighted Customer Service United States: 1-877-4ABBOTT International: Call your Abbott Representative E 7A71 34-3028/R8 This package insert must be read carefully prior to product use. Package insert instructions

More information

See external label 2 C-8 C 96 tests CHEMILUMINESCENCE. CMV IgG. Cat # Step (20-25 C Room temp.) Volume

See external label 2 C-8 C 96 tests CHEMILUMINESCENCE. CMV IgG. Cat # Step (20-25 C Room temp.) Volume DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite D/E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external

More information

READ HIGHLIGHTED CHANGES

READ HIGHLIGHTED CHANGES BIO-FLASH anti-hbs 3000-8581 100 tests The BIO-FLASH anti-hbs is a fully automated chemiluminescent simultaneous immunoassay for quantitative measurement of antibodies to Hepatitis B surface antigen (anti-hbs)

More information

Antibody to Hepatitis B Surface Antigen (Human)

Antibody to Hepatitis B Surface Antigen (Human) en ABBOTT PRISM HBsAg Confirmatory 6E51 G1-0319/R11 Antibody to Hepatitis B Surface Antigen (Human) SE O N LY Revised June 2014 U Customer Service: Contact your local representative or find country specific

More information

CYTOMEGALOVIRUS (CMV) IgM ELISA Kit Protocol

CYTOMEGALOVIRUS (CMV) IgM ELISA Kit Protocol CYTOMEGALOVIRUS (CMV) IgM ELISA Kit Protocol (Cat. No.:EK-310-91) 330 Beach Road, Burlingame CA Tel: 650-558-8898 Fax: 650-558-1686 E-Mail: info@phoenixpeptide.com www.phoenixpeptide.com INTENDED USE The

More information

DIAGNOSTIC AUTOMATION, INC.

DIAGNOSTIC AUTOMATION, INC. DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external

More information

In Vitro Diagnostic Medical Device. Store at 2-8 C. Store at C. CAUTION: Consult accompanying documents

In Vitro Diagnostic Medical Device. Store at 2-8 C. Store at C. CAUTION: Consult accompanying documents E AxSYM HbA1c 3L93-20 ABOL051/R2 Read Highlighted Changes Revised March, 2008 AxSYM HbA1c Customer Service United States: 1-877-4ABBOTT International: Call your Abbott Representative This package insert

More information

Human Cytomegalovirus IgM ELISA Kit

Human Cytomegalovirus IgM ELISA Kit Human Cytomegalovirus IgM Catalog No: IRAPKT2012 ELISA Kit Lot No: SAMPLE INTENDED USE The CMV IgM ELISA is intended for use in the detection of IgM antibodies to Cytomegalovirus (CMV) infection in human

More information

Human Cytomegalovirus Virus (CMV) IgG ELISA Kit

Human Cytomegalovirus Virus (CMV) IgG ELISA Kit Human Cytomegalovirus Virus Catalog No: IRAPKT1410 (CMV) IgG ELISA Kit Lot No: SAMPLE INTENDED USE The CMV IgG ELISA is intended for use in evaluating a patient s serologic status to cytomegalovirus (CMV)

More information

Rubella Latex Agglutination Test

Rubella Latex Agglutination Test Rubella Latex Agglutination Test Cat. No.:DLAT1088 Pkg.Size:30T Intended use The Rubella Latex Agglutination Test is a rapid latex particle agglutination test for the qualitative and semi-quantitative

More information

Rubella virus IgG ELISA Kit

Rubella virus IgG ELISA Kit Rubella virus IgG ELISA Kit Catalog Number KA0223 96 assays Version: 03 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Background... 3 Principle of

More information

See external label 96 tests HSV 2 IgA. Cat #

See external label 96 tests HSV 2 IgA. Cat # DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite D/E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external

More information

Herpes Simplex Virus 2 IgM HSV 2 IgM

Herpes Simplex Virus 2 IgM HSV 2 IgM DIAGNOSTIC AUTOMATION, INC. 21250 Califa Street, Suite 102 and 116, Woodland Hills, CA 91367 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com

More information

Lecture-7- Hazem Al-Khafaji 2016

Lecture-7- Hazem Al-Khafaji 2016 TOXOPLASMOSIS Lecture-7- Hazem Al-Khafaji 2016 TOXOPLASMOSIS It is a disease caused by Toxoplasma gondii which is a protozoan parasite that is infects a variety of mammals and birds throughout the world.

More information

Attachment Insert Quest International, Inc NW 29 Street, Doral, FL

Attachment Insert Quest International, Inc NW 29 Street, Doral, FL 01-110 96-Test Set For in Vitro Diagnostic Use Only Intended Use: For the qualitative detection of human IgM antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the diagnosis of

More information

HSV-1 IgM ELISA. Catalog No (96 Tests) For Research Use Only. Not for use in Diagnostic Procedures.

HSV-1 IgM ELISA. Catalog No (96 Tests) For Research Use Only. Not for use in Diagnostic Procedures. For Research Use Only. Not for use in Diagnostic Procedures. INTENDED USE The GenWay, Inc. HSV-1 IgM ELISA Kit is intended for the detection of IgM antibody to HSV-1 in human serum or plasma. SUMMARY AND

More information

Toxo IgG. Principle of the Test. Introduction

Toxo IgG. Principle of the Test. Introduction Toxo IgG E Principle of the Test The ImmunoComb Toxo IgG test is an indirect solid-phase enzyme immunoassay (EIA). The solid phase is a card with 12 projections ("teeth"). Each tooth is sensitized at two

More information

FinTest IgG4 Screen 20 ELISA KIT

FinTest IgG4 Screen 20 ELISA KIT FinTest IgG4 Screen 20 ELISA KIT Cat. No.:DEIA6196 Pkg.Size:96T Intended use Enzyme immunoassay (microtiter strips) for the detection and the quantitative determination of IgG4 antibodies against 20 Food

More information

Influenza A IgG ELISA

Influenza A IgG ELISA Influenza A IgG ELISA For the qualitative determination of IgG-class antibodies against Influenza A virus in human serum or plasma (citrate, heparin). For Research Use Only. Not For Use In Diagnostic Procedures.

More information

Customer Service: Contact your local representative or find country specific contact information on

Customer Service: Contact your local representative or find country specific contact information on en 7A67 34-5870/R14 Read Highlighted Changes Revised July 2010 Customer Service: Contact your local representative or find country specific contact information on www.abbottdiagnostics.com Package insert

More information

Herpes Simplex Virus 2 IgG HSV 2 IgG

Herpes Simplex Virus 2 IgG HSV 2 IgG DIAGNOSTIC AUTOMATION, INC. 21250 Califa Street, Suite 102 and 116, Woodland Hills, CA 91367 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com

More information

List Number. For In Vitro Diagnostic Use. Store at C

List Number. For In Vitro Diagnostic Use. Store at C E HBsAg (V2) 7A40-22 B7P400 56-4127/R10 HBsAg (V2) This package insert must be read carefully prior to use. Package insert instructions must be carefully followed. Reliability of assay results cannot be

More information

EBV-EA IgG. Cat # 1415Z. EBV -EA IgG ELISA. ELISA: Enzyme Linked Immunosorbent Assay. ELISA - Indirect; Antigen Coated Plate

EBV-EA IgG. Cat # 1415Z. EBV -EA IgG ELISA. ELISA: Enzyme Linked Immunosorbent Assay. ELISA - Indirect; Antigen Coated Plate DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite D/E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external

More information

CDIA TM Rubella IgG/IgM Rapid Test Kit

CDIA TM Rubella IgG/IgM Rapid Test Kit CDIA TM Rubella IgG/IgM Rapid Test Kit Cat.No: DTSJZ024 Lot. No. (See product label) Intended Use The CDIA TM Rubella IgG/IgM Rapid Test Kit is a rapid chromatographic immunoassay for the qualitative detection

More information

Policy # MI/SER/02/v03 Page 1 of 9 Policy & Procedure Manual

Policy # MI/SER/02/v03 Page 1 of 9 Policy & Procedure Manual Policy # MI/SER/02/v03 Page 1 of 9 Section: Subject Title: AxSYM System Issued by: LABORATORY MANAGER Original Date: March 14, 2001 Approved by: Laboratory Director Revision Date: October 28, 2003 AXSYM

More information

VZV IgG ELISA Catalog No (96 Tests)

VZV IgG ELISA Catalog No (96 Tests) INTENDED USE For Research Use Only. Not for use in Diagnostic Procedures. The GenWay, Inc. Kit is intended for the detection of IgG antibody to VZV in human serum or plasma. SUMMARY AND EXPLANATION Varicella

More information

Triiodothyronine (T3) ELISA

Triiodothyronine (T3) ELISA For Research Use Only. Not for use in Diagnostic Procedures. INTENDED USE The GenWay, Inc. Triiodothyronine (T3) ELISA Kit is intended for the detection of total T3 in human serum or plasma. For research

More information

Enzyme Immunoassay (EIA) for the Detection of Toxoplasma IgG Antibodies in Human Serum. For In Vitro Diagnostic Use Only

Enzyme Immunoassay (EIA) for the Detection of Toxoplasma IgG Antibodies in Human Serum. For In Vitro Diagnostic Use Only TOXOPLASMA IgG EIA ID: Blue Enzyme Immunoassay (EIA) for the Detection of Toxoplasma IgG Antibodies in Human Serum. For In Vitro Diagnostic Use Only 25175 96 Tests CONTENTS 1 - INTENDED USE 2 - SUMMARY

More information

FinTest TM IgG4 Screen 88 ELISA Kit

FinTest TM IgG4 Screen 88 ELISA Kit FinTest TM IgG4 Screen 88 ELISA Kit Cat. No.:DEIA6227 Pkg.Size:96T Intended use The Kit is for the quantitative determination of IgG4 antibodies against 88 Food Allergens in human serum, plasma and capillary

More information

H. pylori IgM CLIA kit

H. pylori IgM CLIA kit H. pylori IgM CLIA kit Cat. No.:DEEL0251 Pkg.Size:96 tests Intended use Helicobacter pylori IgM Chemiluminescence ELISA is intended for use in evaluating the serologic status to H. pylori infection in

More information

H.Pylori IgG Cat # 1503Z

H.Pylori IgG Cat # 1503Z DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite D/E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external

More information

Thyroid Stimulating Hormone (TSH) ELISA Catalog No. GWB , legacy id (96 Tests)

Thyroid Stimulating Hormone (TSH) ELISA Catalog No. GWB , legacy id (96 Tests) For Research Use Only. Not for use in Diagnostic Procedures. INTENDED USE The GenWay, Inc. TSH ELISA Kit is intended for the quantitative measurement of TSH in human serum or plasma. For research use only.

More information

Chlamydia Trachomatis IgM ELISA Kit

Chlamydia Trachomatis IgM ELISA Kit Chlamydia Trachomatis IgM ELISA Kit Catalog Number KA0960 96 assays Version: 03 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Background... 3 Principle

More information

BIO-FLASH. BIOKIT, S.A. - Can Malé s/n Lliçà d Amunt - Barcelona - SPAIN

BIO-FLASH. BIOKIT, S.A. - Can Malé s/n Lliçà d Amunt - Barcelona - SPAIN READ HIGHLIGHTED CHANGES BIO-FLASH anti-hbc 3000-8578 100 tests The BIO-FLASH anti-hbc is a fully automated chemiluminescent two-step immunoassay for qualitative measurement of total antibodies to hepatitis

More information

Measles IgM ELISA Kit

Measles IgM ELISA Kit Measles IgM ELISA Kit Catalog Number KA2257 96 assays Version: 03 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Background... 3 Principle of the Assay...

More information

Effective Date: 09/08 Supersedes Revision/Date: Original Revision: 09/08 Date Adopted:

Effective Date: 09/08 Supersedes Revision/Date: Original Revision: 09/08 Date Adopted: Institution: Procedure No.: Page 1 of 5 Procedure: ASI RF DIRECT SLIDE TEST Doc#: 6004-700DC CLSI Effective Date: 09/08 Supersedes Revision/Date: Original Revision: 09/08 Supersedes Procedure # Prepared

More information

Received 8 April 1996/Returned for modification 19 June 1996/Accepted 15 July 1996

Received 8 April 1996/Returned for modification 19 June 1996/Accepted 15 July 1996 JOURNAL OF CLINICAL MICROBIOLOGY, Oct. 1996, p. 2526 2530 Vol. 34, No. 10 0095-1137/96/$04.00 0 Copyright 1996, American Society for Microbiology Study of Abbott Toxo IMx System for Detection of Immunoglobulin

More information

H.Pylori IgG

H.Pylori IgG DIAGNOSTIC AUTOMATION, INC. 21250 Califa Street, Suite 102 and116, Woodland Hills, CA 91367 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com

More information

Anthrax protective antigen IgG ELISA Kit

Anthrax protective antigen IgG ELISA Kit Anthrax protective antigen IgG ELISA Kit Catalog Number KA0953 96 assays Version: 04 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Background... 3

More information

ReQuest EBV EA-D IgG

ReQuest EBV EA-D IgG ReQuest EA-D IgG Intended Use 01-490 96-Test Set The ReQuest EA-D IgG test is for the qualitative detection of human IgG antibodies to Epstein-Barr virus early antigen diffuse (EA-D) in human serum by

More information

Mouse/Rat THYROXINE (T4) ELISA Catalog No (96 Tests)

Mouse/Rat THYROXINE (T4) ELISA Catalog No (96 Tests) For Research Use Only. Not for use in Diagnostic Procedures. INTENDED USE The GenWay, Inc. Mouse/Rat Thryroxine Kit is intended for the detection of total T4 in mouse/rat serum or plasma. SUMMARY AND EXPLANATION

More information

Chlamydia Trachomatis IgG ELISA Kit

Chlamydia Trachomatis IgG ELISA Kit Chlamydia Trachomatis IgG ELISA Kit Catalog Number KA0959 96 assays Version: 03 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Background... 3 Principle

More information

Murex Chlamydia Verification Kit

Murex Chlamydia Verification Kit 1F83-01 E C06DK05GB Murex Chlamydia Verification Kit DK05 For the confirmatory testing of clinical samples reactive in Murex Chlamydia (1F82-01) Note Changes Highlighted 2005 Abbott / Printed in the UK

More information

AIA-600II Assay Specifications TgAb Test Code 048

AIA-600II Assay Specifications TgAb Test Code 048 AIA-600II Assay Specifications TgAb Test Code 048 Screen Item Data Screen 1 Lot ***Enter current cal. lot no. Cal 1 0 IU/mL Cal 2 2 IU/mL (example) Cal 3 4 IU/mL (example) Cal 4 10 IU/mL (example) Cal

More information

Mycoplasma pneumoniae IgG ELISA Kit

Mycoplasma pneumoniae IgG ELISA Kit Mycoplasma pneumoniae IgG ELISA Kit Catalog Number KA2260 96 assays Version: 01 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Background... 3 Principle

More information

FOR IN VITRO DIAGNOSTIC USE

FOR IN VITRO DIAGNOSTIC USE Arlington Scientific, Inc. Page 1 of 10 Created by: Approved By: Date: FOR IN VITRO DIAGNOSTIC USE 1.0 INTENDED USE: For the qualitative and quantitative detection of human IgM antibodies to Toxoplasma

More information

H. pylori IgM. Cat # H. pylori IgM ELISA. ELISA: Enzyme Linked Immunosorbent Assay. ELISA - Indirect; Antigen Coated Plate

H. pylori IgM. Cat # H. pylori IgM ELISA. ELISA: Enzyme Linked Immunosorbent Assay. ELISA - Indirect; Antigen Coated Plate DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite D/E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com H. pylori

More information

IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST

IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST Product No. 3100 For In Vitro Diagnostic Use SEE CALIBRATION VALUES, TABLE 2, PAGE 3 INTENDED USE The ImmunoWELL Cardiolipin Antibody (IgM) Test is an enzyme

More information

Hepatitis A virus IgM ELISA Kit

Hepatitis A virus IgM ELISA Kit Hepatitis A virus IgM ELISA Kit Catalog Number KA0285 96 assays Version: 04 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Background... 3 Principle

More information

TOXOPLASMA IgM. Other Materials Required 1. Microplate washer 2. Pipettors for dispensing 8, 100 and 200 µl

TOXOPLASMA IgM. Other Materials Required 1. Microplate washer 2. Pipettors for dispensing 8, 100 and 200 µl TOXOPLASMA IgM T8002-96 96-Test Set For in Vitro Diagnostic Use Only Intended Use: For the qualitative and quantitative detection of human IgM antibodies to Toxoplasma in human serum by enzyme immunoassay,

More information

Enzyme Immunoassay (EIA) for the Detection of EB VCA IgG Antibodies in Human Serum. For In Vitro Diagnostic Use Only

Enzyme Immunoassay (EIA) for the Detection of EB VCA IgG Antibodies in Human Serum. For In Vitro Diagnostic Use Only EB VCA IgG EIA ID: Black Enzyme Immunoassay (EIA) for the Detection of EB VCA IgG Antibodies in Human Serum. For In Vitro Diagnostic Use Only 25184 96 Tests CONTENTS 1 - INTENDED USE 2 - SUMMARY AND EXPLANATION

More information

H.pylori IgA Cat #

H.pylori IgA Cat # DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite D/E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external

More information

HBeAg and HBeAg Ab ELISA Kit

HBeAg and HBeAg Ab ELISA Kit HBeAg and HBeAg Ab ELISA Kit Catalog Number KA0290 96 assays Version: 17 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Principle of the Assay... 3

More information

ReQuest CMV IgM Test Set For in Vitro Diagnostic Use Only

ReQuest CMV IgM Test Set For in Vitro Diagnostic Use Only 01-150 96-Test Set For in Vitro Diagnostic Use Only Intended Use: For the qualitative detection of human IgM antibodies to cytomegalovirus (CMV) in human serum by enzyme immunoassay, to aid in the diagnosis

More information

Helicobacter pylori IgA ELISA Kit

Helicobacter pylori IgA ELISA Kit Helicobacter pylori IgA ELISA Kit Catalog Number KA0964 96 assays Version: 03 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Background... 3 Principle

More information

INSTRUCTIONS FOR USE

INSTRUCTIONS FOR USE VITROS Immunodiagnostic Products Anti HBc Reagent Pack VITROS Immunodiagnostic Products Anti HBc Calibrator 680 1428 680 1429 Caution: Federal law restricts this device to sale by or on the order of a

More information

Cotinine (Mouse/Rat) ELISA Kit

Cotinine (Mouse/Rat) ELISA Kit Cotinine (Mouse/Rat) ELISA Kit Catalog Number KA2264 96 assays Version: 03 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Background... 3 Principle

More information

IMMUNODOT MONO-M TEST

IMMUNODOT MONO-M TEST IMMUNODOT MONO-M TEST For In Vitro Diagnostic Use INTENDED USE The Mono-M Test is a qualitative enzyme immunoassay (EIA) that detects IgM antibodies to Paul-Bunnell heterophil, Epstein- Barr virus capsid

More information

Chlamydia Trachomatis IgA

Chlamydia Trachomatis IgA DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external

More information

MICROWELL ELISA Measles IgM Catalog #

MICROWELL ELISA Measles IgM Catalog # DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external

More information

H. pylori Antigen ELISA Kit

H. pylori Antigen ELISA Kit H. pylori Antigen ELISA Kit Catalog Number KA3142 96 assays Version: 04 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Background... 3 Principle of

More information

IMMUNODOT HERPES SIMPLEX VIRUS TYPING

IMMUNODOT HERPES SIMPLEX VIRUS TYPING IMMUNODOT HERPES SIMPLEX VIRUS TYPING For In Vitro Diagnostic Use INTENDED USE ImmunoDOT Herpes Simplex Virus (HSV) Typing test is an enzyme immunoassay (EIA) detecting HSV or glycoprotein G (gg) type

More information

This kit is intended for Research Use Only. Not for use in diagnostic procedures.

This kit is intended for Research Use Only. Not for use in diagnostic procedures. This kit is intended for Research Use Only. Not for use in diagnostic procedures. Introduction The DRG Epstein-Barr Virus (VCA) IgM Enzyme Immunoassay Kit provides materials for determination of IgM-class

More information

H.Pylori IgM Cat # 1504Z

H.Pylori IgM Cat # 1504Z DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite D/E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external

More information

EBV EA-D IgG. Intended Use. Summary and Explanation of Test. Principle of the Test. Materials Provided. Materials Required But Not Provided

EBV EA-D IgG. Intended Use. Summary and Explanation of Test. Principle of the Test. Materials Provided. Materials Required But Not Provided EA-D IgG Intended Use 01-490 96-Test Set The SeraQuest EA-D IgG test is for the qualitative detection of human IgG antibodies to Epstein-Barr virus early antigen diffuse (EA-D) in human serum by enzyme

More information

Toxo IgM. Figure 1. Principle of the Test

Toxo IgM. Figure 1. Principle of the Test Code: 50441002 Toxo IgM For In vitro Diagnostic Use only Format: 3 x 12 tests Intended Use The ImmunoComb Toxo IgM Kit is a test intended for the qualitative detection of IgM antibodies to Toxoplasma gondii

More information

Testosterone ELISA. Catalog No (96 Tests) For Research Use Only. Not for use in Diagnostic Procedures.

Testosterone ELISA. Catalog No (96 Tests) For Research Use Only. Not for use in Diagnostic Procedures. For Research Use Only. Not for use in Diagnostic Procedures. INTENDED USE The GenWay, Inc. Testosterone ELISA is for the quantitative determination of Testosterone concentration in human serum or plasma

More information

EBV-VCA IgM Enzyme Immunoassay

EBV-VCA IgM Enzyme Immunoassay For Individual Laboratory to Complete: Laboratory Name EBV-VCA IgM Enzyme Immunoassay Adopted Reviewed Reviewed Revised Supercedes Method: Diamedix Corp., Immunosimplicity Manual or in conjunction with

More information

Arlington Scientific, Inc. Page 1 of 8. Doc#: ASI TOXOPLASMA IgG EIA TEST

Arlington Scientific, Inc. Page 1 of 8. Doc#: ASI TOXOPLASMA IgG EIA TEST Arlington Scientific, Inc. Page 1 of 8 Prepared by: ASI QA Approval by: Copy/Dept.: FOR IN VITRO DIAGNOSTIC USE 1.0 INTENDED USE: For the qualitative, semiquantitative or quantitative detection of human

More information

ReQuest EB VCA IgM L

ReQuest EB VCA IgM L 01-480 96-Test Set For in Vitro Diagnostic Use Only Intended Use: For the qualitative detection of human IgM antibodies to Epstein-Barr (EB) viral capsid antigen (VCA) in human serum by enzyme immunoassay,

More information

See external label 2 C-8 C Σ=96 tests Cat # 1505Z. MICROWELL ELISA H.Pylori IgA Cat # 1505Z

See external label 2 C-8 C Σ=96 tests Cat # 1505Z. MICROWELL ELISA H.Pylori IgA Cat # 1505Z DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external

More information

HAV IgG/IgM Rapid Test

HAV IgG/IgM Rapid Test HAV IgG/IgM Rapid Test Cat. No.:DTS649 Pkg.Size: Intended use CD HAV IgG/IgM Rapid Test is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM

More information

IMMUNODOT MONO-G TEST

IMMUNODOT MONO-G TEST IMMUNODOT MONO-G TEST For In Vitro Diagnostic Use INTENDED USE The Mono-G Test is a qualitative enzyme immunoassay (EIA) that detects IgG antibodies to Epstein-Barr virus capsid antigen (EBV-VCA), Epstein-Barr

More information

Innovation in Diagnostics. ToRCH. A complete line of kits for an accurate diagnosis INFECTIOUS ID DISEASES

Innovation in Diagnostics. ToRCH. A complete line of kits for an accurate diagnosis INFECTIOUS ID DISEASES Innovation in Diagnostics ToRCH A complete line of kits for an accurate diagnosis INFECTIOUS ID DISEASES EN TOXOPLASMOSIS Toxoplasmosis is a parasitic disease caused by with the obligate intracellular

More information

NEPHROCHECK Calibration Verification Kit Package Insert

NEPHROCHECK Calibration Verification Kit Package Insert NEPHROCHECK Calibration Verification Kit Package Insert Manufactured for Astute Medical, Inc. 3550 General Atomics Ct. Building 2 San Diego, CA 92121 USA Intended Use The NEPHROCHECK Calibration Verification

More information

AccuDiag Herpes Simplex 2 IgG. HSV 2 IgG ELISA

AccuDiag Herpes Simplex 2 IgG. HSV 2 IgG ELISA AccuDiag Herpes Simplex 2 IgG (HSV 2 IgG) ELISA Test Method Principle Cat# 1403-2 96 Tests HSV 2 IgG ELISA: Enzyme Linked Immunosorbent Assay Indirect: Antibody Capture Detection Range Qualitative: Positive,

More information

en Tricyclic Antidepressants 3B34

en Tricyclic Antidepressants 3B34 en Tricyclic Antidepressants 3B34 34-6046/R09 Tricyclic Antidepressants Read Highlighted Changes Revised September 2010 Customer Service: Contact your local representative or find country specific contact

More information

TNF-alpha ELISA. For Research Use Only. Not For Use In Diagnostic Procedures.

TNF-alpha ELISA. For Research Use Only. Not For Use In Diagnostic Procedures. TNF-alpha ELISA For the quantitative determination of TNF-alpha in serum, plasma, buffered solution or cell culture medium. For Research Use Only. Not For Use In Diagnostic Procedures. Catalog Number:

More information

Short Video. shows/monsters-inside- me/videos/toxoplasma-parasite/

Short Video.  shows/monsters-inside- me/videos/toxoplasma-parasite/ The word Toxoplasma Originated from the Greek word toxon, which meant "bow." The Latin word toxicum, which meant "poison." The original Greek meaning is the one used for the word Toxoplasma, meaning "bow

More information

ELEGANCE Chlamydia pneumoniae IgG ELISA KIT

ELEGANCE Chlamydia pneumoniae IgG ELISA KIT INTENDED USE The ELEGANCE Chlamydia pneumoniae IgG ELISA has been designed for the in vitro diagnostic measurement of anti- Chlamydia pneumoniae IgG in the screening of human serum. PRINCIPLES OF THE ELEGANCE

More information

Treponema Pallidum Total Antibody ELISA

Treponema Pallidum Total Antibody ELISA For Research Use Only. Not for use in Diagnostic Procedures. INTENDED USE The GenWay, Inc. Treponima pallidum Total ELISA Kit is intended for the detection of IgG, IgM and IgA antibody to Treponima pallidum

More information

See external label 2 C-8 C Σ=96 tests Cat # EBV-VCA IgA. Cat # EBV -VCA IgA ELISA. ELISA: Enzyme Linked Immunosorbent Assay

See external label 2 C-8 C Σ=96 tests Cat # EBV-VCA IgA. Cat # EBV -VCA IgA ELISA. ELISA: Enzyme Linked Immunosorbent Assay DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite D/E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external

More information

Human HIV (1+2) antigen&antibody ELISA Kit

Human HIV (1+2) antigen&antibody ELISA Kit Human HIV (1+2) antigen&antibody ELISA Kit Catalog Number. CSB-E18042h For the qualitative determination of human HIV (1+2) antibody and P24 antigen concentrations in serum, plasma. This package insert

More information

PLATELIA CANDIDA Ab PLUS Negative and Positive Controls. Quality Control Human Sera

PLATELIA CANDIDA Ab PLUS Negative and Positive Controls. Quality Control Human Sera PLATELIA CANDIDA Ab PLUS Negative and Positive Controls 48 62787 Quality Control Human Sera CONTENTS 1. INTENDED USE...3 2. INDICATIONS FOR USE...3 3. REAGENTS...3 4. WARNING FOR USERS...4 5. PRECAUTIONS

More information

IV2-113E Use by. Invitron Glargine ELISA Kit REF LOT IVD. Definitions. English. For in-vitro diagnostic use. Instructions for use.

IV2-113E Use by. Invitron Glargine ELISA Kit REF LOT IVD. Definitions. English. For in-vitro diagnostic use. Instructions for use. Definitions Instructions for use REF Catalogue number IV2-113E Use by English Invitron Glargine ELISA Kit For in-vitro diagnostic use Σ 96 LOT IVD Lot/Batch Code Storage temperature limitations In vitro

More information

Anti-HCV Reagent Pack (STM) PIGEM1244/102.0

Anti-HCV Reagent Pack (STM) PIGEM1244/102.0 Anti-HCV Reagent Pack (STM) PIGEM1244/102.0 Symbols used» 3 SN 4 Ó e i = 'n' tests 1 j Use by/expiration date (Year Month Day) Lot Number Serial number Catalogue number Attention, see instructions for

More information

Standard Operating Procedure

Standard Operating Procedure Subject Free Thyroxine (FT4-II) cobas e411 Index Number Lab-1594 Section Regional/Affiliate Subsection Laboratory Category Departmental Contact Goplin, Darcy Last Revised 2/2/2017 References Required document

More information

Human Hemoglobin Colorimetric Detection Kit

Human Hemoglobin Colorimetric Detection Kit Human Hemoglobin Colorimetric Detection Kit CATALOG NO: IRAAKT2522 LOT NO: SAMPLE INTENDED USE The Hemoglobin detection kit is designed to quantitatively measure all forms of hemoglobin present in blood

More information

Human Thyroid Stimulating Hormone CLIA kit

Human Thyroid Stimulating Hormone CLIA kit Human Thyroid Stimulating Hormone CLIA kit Cat. No.:DEEL0223 Pkg.Size:96 tests Intended use For the direct quantitative determination of Thyroid Stimulating Hormone in human serum by chemiluminescence

More information