Performance Characteristics of the COBAS AMPLICOR Hepatitis C Virus MONITOR Test, Version 2.0
|
|
- Alison Stevenson
- 6 years ago
- Views:
Transcription
1 Clinical Chemistry / EVALUATION OF QUANTITATIVE HEPATITIS C VIRUS ASSAY Performance Characteristics of the COBAS AMPLICOR Hepatitis C Virus MONITOR Test, Version 2.0 Maria Erali, MS, 1 Edward R. Ashwood, MD, 1,2 and David R. Hillyard, MD 1,2 Key Words: Hepatitis C virus; HCV RNA quantitation; COBAS AMPLICOR HCV MONITOR test, version 2.0; QUANTIPLEX HCV bdna test Abstract We evaluated the performance characteristics of the COBAS AMPLICOR Hepatitis C Virus (HCV) MONITOR Test, version 2.0. Dilution studies using patient specimens demonstrated a lower limit of detection of 1,000 copies per milliliter. The assay was linear from 1,000 to 1 million HCV RNA copies per milliliter. Within-run precision and between-run precision were acceptable (approximately and 0.14 SD for log 10 [copies per milliliter]). A comparison of this version of the test (y), with the manual AMPLICOR HCV MONITOR Test, version 1.0 (x), yielded the following Deming regression equation: y = 1.004(± 0.04)x (± 0.22); S y/x D = 0.6; n = 92; r 2 = 0.846; r = Further comparison of the COBAS version 2.0 assay (x) with the QUANTIPLEX HCV bdna Test (y) yielded the following Deming regression equation: y = 0.94 (±0.10)x (±0.717); S y/x D = 0.194; n = 26; r 2 = 0.600; r = Version 2.0 detected the spectrum of HCV genotypes better than version 1.0. The present study was undertaken to evaluate the performance characteristics of the second-generation AMPLICOR HCV MONITOR Test (Roche Diagnostics, Indianapolis, IN) as it is configured for the COBAS AMPLICOR Analyzer (Roche Diagnostics). Hepatitis C virus (HCV) is a positive-strand RNA virus that is a major cause of viral hepatitis worldwide. The virus has been classified into 6 major genotypes and a large number of subtypes based on the variability of the nucleic acid sequence. 1,2 Since the advent of serologic screening for HCV in 1989, the rate of new infection has declined from 250,000 per year to an estimated 0,000 per year. The total number of persons infected with HCV in the United States is almost 4 million, 2 and as many as 10,000 deaths a year can be attributed to HCV infection. Tests that determine the level of HCV RNA in serum are useful for managing HCV infection. Qualitative and quantitative assays are available for detecting HCV RNA. Quantitative serum HCV RNA results may be useful as prognostic indicators of the severity of disease and response to therapy. They also may be used for monitoring response to therapy and relapse after the end of treatment. There are 2 major commercially available, research use only, methods for determining HCV RNA levels that are based on different techniques: (1) target amplification by reverse transcriptase polymerase chain reaction (RT-PCR) (Roche AMPLICOR) and (2) signal amplification by branched DNA (bdna) (Chiron QUANTIPLEX, Chiron, Emeryville, CA). Others have reported differences between these assays in sensitivity, reproducibility, agreement, and ability to detect genotypes. -7 With the availability of improved treatment regimens, it is important to have reliable tests for measuring HCV RNA levels to provide meaningful information about 180 Am J Clin Pathol 2000;114: American Society of Clinical Pathologists
2 Clinical Chemistry / ORIGINAL ARTICLE prognosis and response to therapy. The quantitative AMPLICOR HCV MONITOR Test, version 2.0 (Roche Diagnostics) is the second-generation format for the RT-PCR AMPLICOR HCV MONITOR Test, version 1.0. The version 2.0 chemistry has been modified by the manufacturer in an attempt to improve the efficiency of nucleic acid amplification and is expected to provide enhanced detection of genotypes. In addition, the version 2.0 is available on the COBAS AMPLICOR Analyzer, which allows automated amplification, detection, and reporting for HCV RNA quantitation. We studied the sensitivity and reproducibility of the AMPLICOR HCV MONITOR Test, version 2.0, and compared the version 2.0 assay with the version 1.0. An analysis of the ability of version 2.0 to detect genotypes was made, and results from the AMPLICOR HCV MONITOR Test, version 2.0 were compared with the QUANTIPLEX HCV RNA 2.0 bdna Test. Materials and Methods Clinical Specimens Correlation and precision studies were done using EDTA-anticoagulated plasma or serum samples submitted to ARUP Laboratories, Salt Lake City, UT, for HCV quantitation. Whole blood was drawn in serum separation tubes (SST, Becton Dickinson, Franklin Lakes, NJ) or tubes containing EDTA as anticoagulant and processed within 0 minutes. As described in the AMPLICOR HCV MONITOR package insert, serum or plasma was separated from cells by centrifugation at 1,500g for 20 minutes at room temperature, divided into aliquots, and frozen for storage at 20 C or lower. HCV Quantitation by the AMPLICOR HCV MONITOR Test, Version 1.0 HCV RNA was quantitated using the AMPLICOR HCV MONITOR Test, version 1.0 (Roche Diagnostics) according to the manufacturer s instructions. Viral lysis was done by adding 100 µl of serum or plasma to a lysis solution containing guanidine thiocyanate and the Roche-supplied Quantitation Standard (QS) required for determining RNA levels. The QS is an in vitro transcribed RNA molecule with HCV primer binding sites and a unique probe binding site. The QS is added at a known concentration to each specimen to provide a reference for quantification of HCV RNA. Following lysis, nucleic acid extraction was accomplished by isopropanol precipitation and ethanol wash. The nucleic acid was resuspended in the Roche-supplied specimen diluent containing tris(hydroxymethyl)aminomethane hydrochloride, synthetic poly ra RNA, EDTA, and sodium azide. Extracted samples were added to a PCR reagent mixture containing recombinant Thermus thermophilus (rtth) DNA polymerase in a buffer with the appropriate concentrations of manganese, primers, and nucleotide triphosphates to allow RT-PCR of a 244-base-pair product located in the 5 untranslated region of the HCV genome. AmpErase (uracil N-glycosylase) was incorporated by Roche into the PCR reagent mixture with deoxyuridine triphosphate (dutp) to ensure selective amplification of target nucleic acid. Thermal cycling was done in a GeneAmp PCR System 9600 (Perkin-Elmer, Norwalk, CT). Detection was accomplished using an enzyme-based colorimetric microwell assay format that uses solid-phase probes complementary to the HCV and QS amplicons. Absorbance measurements were done on an El X 800 plate reader (Bio-Tek Instruments, Winooski, VT). Viral RNA levels were calculated as HCV RNA copies per milliliter according to a formula that includes the absorbance values for the QS and HCV amplicons. HCV Quantitation by the COBAS AMPLICOR HCV MONITOR Test, Version 2.0 HCV RNA was quantitated using the COBAS AMPLICOR HCV MONITOR Test, version 2.0 according to the manufacturer s directions. Viral lysis was performed as in the version 1.0 manual assay. Following lysis, nucleic acid extraction was accomplished by isopropanol precipitation and ethanol wash. The nucleic acid was resuspended in 1 ml of specimen diluent. Fifty microliters of the extracted samples were added to 50 µl of the version 2.0 PCR reagent mixture. This reagent is modified in the version 2.0 assay to contain dimethyl sulfoxide in the buffer containing rtth DNA polymerase, manganese, primers, nucleotide triphosphates (including dutp), and AmpErase. The primers allowed RT-PCR of a 244-base-pair product located in the 5 untranslated region of the HCV genome. Thermal cycling and detection were done on the COBAS AMPLICOR Analyzer with no further technician intervention. Detection was accomplished on the COBAS AMPLICOR Analyzer in a colorimetric format using suspensions of magnetic particles coated with probes specific for the HCV and QS amplicons. Absorbance measurements were done by the COBAS AMPLICOR Analyzer. Viral RNA levels were calculated by the instrument and reported as HCV RNA copies per milliliter. HCV Quantitation by the QUANTIPLEX HCV RNA 2.0 bdna Test HCV RNA quantitation of plasma samples by the QUANTIPLEX HCV RNA 2.0 bdna Test was performed by an outside reference laboratory. The bdna method used signal amplification based on the hybridization of probes specific to sequences in the 5 untranslated region of the American Society of Clinical Pathologists Am J Clin Pathol 2000;114:
3 Erali et al / EVALUATION OF QUANTITATIVE HEPATITIS C VIRUS ASSAY HCV genome. Additional probes and synthetic bdna molecules were used to attach multiple enzyme labeled probes that were used in a chemiluminescent reaction to detect HCV RNA in the sample. Quantitation of HCV RNA in the QUANTIPLEX HCV RNA 2.0 bdna Test was accomplished by comparing unknowns to an external calibration curve. Results are reported as HCV RNA equivalents (Eq) per milliliter. Dilution Samples Clinical specimens that were quantitated for HCV RNA levels in the COBAS AMPLICOR HCV MONITOR Test, version 2.0, were diluted serially in HCV seronegative normal human plasma. Dilutions were prepared to provide values throughout the expected range of the assay, 1,000 to 1 million HCV RNA copies per milliliter. Duplicate and triplicate determinations were made on the diluted samples in the COBAS AMPLICOR HCV MONITOR Test, version 2.0. The 1,000 copies per milliliter limit of detection corresponds to 100 extracted copies of nucleic acid (100 µl 1,000 copies per milliliter) and 5 copies introduced to the PCR (50 µl/1,000 µl 100 copies). HCV Genotype Genotype determination was done using RT-PCR amplification followed by nucleic acid sequence analysis. Nucleic acid was extracted from samples by guanidine thiocyanate lysis and isopropanol precipitation with an ethanol wash. RT- PCR was performed in PCR reagent mixture containing rtth polymerase, manganese, primers, nucleotide triphosphates (including dutp), AmpErase, and dimethyl sulfoxide. The primers were identical to the primers used in the AMPLICOR HCV MONITOR tests and allowed RT-PCR of a 244-basepair product located in the 5 untranslated region of the HCV genome. Amplified product was purified using a Qiagen QIAquick PCR purification column (Qiagen, Valencia, CA) and cycle sequenced using Big Dye Terminator chemistry (PE-Applied Biosystems, Foster City, CA). Product from the cycle sequencing was purified by precipitation with an ethanol salt solution and underwent polyacrylamide gel electrophoresis on the ABI Prism 77 DNA Sequencer (PE- Applied Biosystems) for determination of nucleotide sequence. Genotype identification was made by reference to a sequence analysis database program created with HCV genotype sequence information found in the National Center for Biotechnology Information GenBank database. Data Analysis Before analysis, all HCV RNA results were converted to log 10 (copies per milliliter). Reproducibility was evaluated by determining the SD and the percentage of the coefficient of variation for within-run and between-run replicates. Linear regression analysis was used to analyze observed and expected values in the dilution study. Deming regression analysis was used for comparison of methods. Results Linearity Study Serial dilutions of 11 samples were prepared, and the HCV RNA levels were measured in the COBAS AMPLICOR HCV MONITOR Test, version 2.0. The individual dilutions were tested in triplicate for all except 4 dilutions. One dilution was run in duplicate owing to space restrictions on the instrument. Calculations were done using duplicate measurements on other samples, which in each case had 1 replicate that did not quantify. The mean observed values for the 4 samples run in duplicate were.2, 2.9,.6, and.0 log 10 (copies per milliliter). Expected values for each dilution series were established by using the observed result for that series that was greater than.0 and less than 6.0 HCV RNA log 10 (copies per milliliter), usually the result closest to 4.5 log 10 (copies per milliliter). The observed results used to establish the expected values were not used in the final analysis. The dilutions that had measurable HCV RNA (n = 5) were evaluated in a plot of the mean of the triplicate or duplicate observed values vs the expected values Figure 1. These data show that the COBAS AMPLICOR HCV MONITOR Test, version 2.0, is almost linear over the range of.0 to 6.0 HCV RNA log 10 (copies per milliliter). The linearity becomes compromised at measurements made above 6.0 and below.0 HCV RNA log 10 (copies per milliliter) as shown by the leveling off of the data in these ranges. Within-Run Reproducibility Within-run reproducibility was evaluated by using the triplicate determinations made on 56 dilutions evaluated in the linearity study. The SDs of the log 10 (copies per milliliter) were calculated and plotted against the average log 10 (copies per milliliter) for each sample. The trend in data was analyzed using a second-order polynomial curve fit Figure 2. A SD for log 10 (copies per milliliter) of or less is considered acceptable within-run reproducibility. The within-run reproducibility for samples with higher HCV RNA levels was well within this specification; however, as the level of HCV RNA approached the.0 log 10 (copies per milliliter) detection limit of the assay, the SD trended upward. Between-Run Reproducibility Between-run reproducibility was evaluated by using the high and low positive controls included with the COBAS 182 Am J Clin Pathol 2000;114: American Society of Clinical Pathologists
4 Clinical Chemistry / ORIGINAL ARTICLE 7 Observed Standard Deviation Expected Figure 1 Observed (y) vs expected (x) hepatitis C virus (HCV) RNA log 10 (copies per milliliter) for a dilution series measured in the COBAS AMPLICOR HCV MONITOR Test, version 2.0 (Roche Diagnostics, Indianapolis, IN). The equation for the linear regression line is y = 0.85 (± 0.016)x (± 0.080); S y/x = 0.148; n = 5; r 2 = 0.982; r = The diagonal dashed line is the line of unity. The upper and lower horizontal dashed lines are 1 million and 1,000 copies per milliliter, respectively. Figure 2 Within-run precision profile. The SD of triplicate determinations vs the mean hepatitis C virus (HCV) RNA log 10 (copies per milliliter). The solid trend line was generated by using a second-order polynomial curve fit. The horizontal dashed line is an SD of The vertical dashed line is the limit of detection of the assay,.0 log 10 (copies per milliliter). AMPLICOR HCV MONITOR, version 2.0 kits. Reproducibility was measured on 1 lot of reagents over 27 days with different operators and different instruments. The total number of determinations made was 70 for the high control and 72 for the low control. The mean values for the high and low controls were 150,000 HCV RNA copies per milliliter (5.1 log 10 [copies per milliliter]) and 8,000 HCV RNA copies per milliliter (.9 log 10 [copies per milliliter]), respectively. The percentage of the coefficient of variation of the copies per milliliter for the high control was 66%, and the SD of the log 10 (copies per milliliter) was For the low control, the percentage of the coefficient of variation of the copies per milliliter was %, and the SD of the log 10 (copies per milliliter) was A Levey-Jennings plot of the data is presented in Figure. Comparison With Manual AMPLICOR HCV MONITOR Test, Version 1.0 A total of 146 samples were measured in singlet in the manual version 1.0 and in COBAS version 2.0 AMPLICOR HCV MONITOR tests. Of the samples, 92 had levels of HCV RNA that quantified in both assays. A Deming regression analysis was performed on the data Figure 4. The overall correlation of the 2 assays was good; however, the values obtained in the COBAS version 2.0 assay were on average about log 10, or almost 5-fold higher than in the manual version 1.0. This variation might have been due to differences in the ability of the 2 assays to detect the various HCV genotypes. To study the possible effect of genotype on HCV RNA levels between the methods, a number of the more discrepant samples were chosen for genotype determination. Genotype Determination of Discrepant Samples Twenty samples that differed in the COBAS version 2.0 from the manual version 1.0 by at least 0.50 log 10 (copies per milliliter), or a -fold difference in copies per milliliter, were analyzed to determine the HCV genotype. The genotypes for the samples tested are given in Table 1. The genotype distribution in this population was as follows: 1a, 4 of 20 (20%); 1b, of 20 (15%); 2a, 2 of 20 (10%); a, 10 of 20 (50%); and 4a, 1 of 20 (5%). Comparison With QUANTIPLEX HCV RNA 2.0 bdna Test Forty-five samples were measured in both the COBAS HCV MONITOR Test version 2.0 and the QUANTIPLEX HCV 2.0 bdna Test. Twenty-six samples that quantified in both assays were compared by Deming regression analysis Figure 5. American Society of Clinical Pathologists Am J Clin Pathol 2000;114:
5 Erali et al / EVALUATION OF QUANTITATIVE HEPATITIS C VIRUS ASSAY Cobas version Run Number Figure A Levey-Jennings plot of the high control (closed circle) and low control (open circle) for the COBAS AMPLICOR HCV MONITOR Test, version 2.0 (Roche Diagnostics, Indianapolis, IN). For the high control, n = 70 measured over 27 days by operators on instruments. For the low control, n = 72 measured over 27 days by operators on instruments. The mean log 10 (copies per milliliter) for the high and low controls is 5.1 and.9, respectively. The dashed error bars are 2 SD units. 4 5 Manual version Figure 4 Hepatitis C virus (HCV) RNA log 10 (copies per milliliter) for 92 clinical specimens as determined by the COBAS version 2.0 (y) and the manual version 1.0 (x) AMPLICOR HCV MONITOR tests (Roche Diagnostics, Indianapolis, IN). The equation for the Deming regression line (solid line) is y = (±0.04)x (±0.22); S y/x D = 0.6; r 2 = 0.846; r = The diagonal dashed line is the line of unity. Table 1 Hepatitis C Virus Genotypes Determined for 20 Samples * HCV RNA (copies/ml) Genotype Manual Version 1.0 COBAS Version 2.0 Fold Difference 1a 5,200 4, ,000 2,200, ,600 12, ,000 67, b 800,000 2,600,000 2,700 1,000 5, , a 92, , ,000,200, a 2,500 52, ,000,700, ,000 70, , , , , ,000 60, , , ,400 99, , , , , a 170,000 2,400, * The samples chosen for genotyping quantified greater than -fold higher, or 0.50 log 10 (copies per milliliter), in the COBAS version 2.0 (AMPLICOR HCV MONITOR Test, version 2.0, Roche Diagnostics, Indianapolis, IN) than in the manual version 1.0 (AMPLICOR HCV MONITOR Test, Roche Diagnostics). 184 Am J Clin Pathol 2000;114: American Society of Clinical Pathologists
6 Clinical Chemistry / ORIGINAL ARTICLE Quantiplex HCV bdna HCV RNA log 10 (Eq/mL) Discussion Cobas Amplicor HCV Monitor, v2.0 Figure 5 Hepatitis C virus (HCV) RNA log 10 (copies per milliliter) for 26 clinical specimens as determined by the QUANTIPLEX HCV RNA 2.0 bdna Test (y) (Chiron, Emeryville, CA) and the COBAS AMPLICOR HCV MONITOR Test, version 2.0 (x) (Roche Diagnostics, Indianapolis, IN). The equation for the Deming regression line (solid line) is y = 0.94 (±0.10)x (±0.717); S y/x D = 0.194; r 2 = 0.600; r = The diagonal dashed line is the line of unity. The vertical dashed line is the upper limit of detection of the COBAS assay, 1 million HCV RNA copies per milliliter. The horizontal dashed line is the lower limit of detection of the QUANTIPLEX assay, 200,000 HCV RNA equivalents per milliliter. Compared with quantitative RNA testing for HIV-1, the indications for quantitative HCV measurement remain less certain, and recommendations for testing are poorly standardized. Nevertheless, quantitative serum HCV RNA levels are used widely to estimate disease prognosis, for monitoring therapy, and as a general indicator of clinical outcome. The association of high HCV levels with poor clinical outcome does not warrant testing for exclusion of patients from therapy, but recent data suggest an important role for HCV viral load testing in determining the appropriate length of treatment. Although the use of serial HCV quantification for therapeutic monitoring has been discussed extensively in the literature, especially for interferon monotherapy, 8,9 consensus is lacking. An alternative approach to serial quantitative monitoring is to test the patient at the end of therapy with a sensitive qualitative HCV assay. As more studies on current therapies are completed and as the next generation of more effective HCV antiviral drugs becomes available, more clear-cut indications for quantitative HCV monitoring will hopefully emerge. In addition to these difficulties, the clinician should understand the performance attributes of the various HCV assays referenced in current clinical studies and how they compare with one another. Our evaluation of the COBAS AMPLICOR HCV MONITOR Test, version 2.0, included an assessment of the reproducibility, sensitivity, and dynamic range of the assay, as well as comparison of the assay with the first-generation AMPLICOR HCV MONITOR Test and the QUANTIPLEX HCV bdna Test. In addition, we performed sequence-based genotyping on samples most discrepant between the version 1.0 and 2.0 AMPLICOR assays as an indication of the ability of the new assay to better detect the various genotypes. The COBAS AMPLICOR HCV MONITOR Test, version 2.0, performed reproducibly and reliably. The within-run precision and between-run precision were acceptable with SDs for log 10 (copies per milliliter) of less than 0.150, or a -fold variation in copies per milliliter. The linearity studies supported a reportable range of 1,000 to 1 million HCV RNA copies per milliliter. The reproducibility of the assay was good across the -log dynamic range; however, greater imprecision was evident at the low end. Above 1 million HCV RNA copies per milliliter, the values generated by the assay were reproducible but not reliable, and dilutions are necessary to obtain accurate results. Comparison of the COBAS version 2.0 assay with the manual version 1.0 assay showed generally improved detection of all samples in the COBAS version 2.0 assay. This improvement was reflected as an average 5-fold increase in HCV RNA levels when measured in the COBAS version 2.0 assay vs the manual version 1.0 assay. Since large changes in viral level are expected for patients with HCV undergoing therapy, a 5-fold difference in values between the 2 assay versions should not mislead clinicians. However, for serial values obtained for 1 patient with the 2 versions, care should be taken in interpreting results when the HCV RNA levels do not decrease dramatically. When the genotypes of samples with large viral load increases in the COBAS version 2.0 assay were determined, it was evident that the ability of the test to detect various genotypes is much improved over the version 1.0 assay. A number of earlier studies suggested that HCV quantitation was higher in infections with genotype 1b and lower in infections with type 2a or 2b. 10,11 It is now evident that the method used to measure the levels of HCV RNA greatly influenced the apparent HCV level. The first-generation Roche assay for HCV, version 1.0, has been shown to underestimate viral loads in HCV infections with genotypes 2 and 4,6,12 compared with other methods. In the present study, 65% of the discrepant samples genotyped were types 2,, or 4. Since these types constitute only 2% of the clinical samples reported by our laboratory, these results indicate that American Society of Clinical Pathologists Am J Clin Pathol 2000;114:
7 Erali et al / EVALUATION OF QUANTITATIVE HEPATITIS C VIRUS ASSAY detection of these genotypes is much improved in the version 2.0 assay. This conclusion also is supported by a recent study that extensively evaluated the ability of the AMPLICOR version 2.0 assay to detect various HCV genotypes. 1 The incomplete detection of various genotypes in the version 1.0 assay may have been related to the efficiency of PCR amplification in the 5 untranslated region of the HCV genome. While this is considered a fairly well-conserved region of the genome, sequence variations among the different genotypes exist. The efficiency of PCR amplification may be affected by these sequence variations. The addition of dimethyl sulfoxide by Roche to the PCR reagent mixture in the version 2.0 AMPLICOR HCV MONITOR Test seems to have allowed improved and equivalent amplification of the various genotypes. The ability of the AMPLICOR HCV MONITOR Test, version 2.0, to more accurately detect genotypes will contribute to a better understanding of the importance of genotype on viral load and its relationship to disease and treatment outcome. The COBAS AMPLICOR HCV MONITOR Test, version 2.0, and the Chiron QUANTIPLEX HCV RNA 2.0 bdna Test generated fairly comparable results over the narrow range evaluated. Since the QUANTIPLEX assay has a lower limit of detection of 200,000 Eq/mL and the AMPLICOR assay has an upper limit of detection of 1 million copies per milliliter, the range that could be evaluated was rather narrow. However, these data suggest that modifications made to the COBAS AMPLICOR HCV MONITOR Test, version 2.0, reduce the differences in quantitation previously observed between the 2 assay platforms. Improvements in the COBAS AMPLICOR HCV MONITOR Test have resulted in an average 5-fold increase in the quantitative result for a given clinical sample and in more uniform detection of different viral types. These changes underscore the need for standardized calibration of all qualitative and quantitative HCV molecular assays. Recent studies examining the outcomes of patients undergoing combination interferon alfa and ribavirin treatment have relied on HCV measurements using a multicycle RT-PCR method that uses gel electrophoresis and Southern blot end detection. 14 These studies ascribe a clinical significance to HCV RNA levels that are greater than or less than 2 million copies per milliliter. Lack of standardized calibration of HCV RNA quantitative units makes comparison of clinical studies difficult and limits the interpretation of clinical hypotheses generated by different study groups. Nonstandardization also creates confusion for clinicians who use a different HCV quantitative assay system to monitor their patients when following clinical recommendations from the literature. An important question is whether the 2 million copies per milliliter reported in the ribavirin-interferon trials are equivalent to the copies per milliliter reported in other assays, including the widely used Roche test. In addition, it is also important to ask whether it is appropriate to assign 2 million copies per milliliter as a special cutoff with unique clinical significance or whether there may be a gradual gradient of outcomes associated with viral titer. The accuracy of different assay systems in the broad ranges above and below the 2-million-unit cutoff must be evaluated. An international calibration standard for HCV RNA is being established to provide reference material that could be used for the standardization of various HCV RNA assays. 15 Standardization of quantitative and qualitative molecular infectious disease assays should be a high priority for developers of commercial tests and for those developing tests using in-house reagents and formats. Reporting in standardized units with the benefit of validation studies that examine test performance for the widely used test assays is a necessary precedent for appropriate understanding and interpretation of results generated using different methods. From the 1 ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT, and the 2 Department of Pathology, University of Utah Health Sciences Center, Salt Lake City. Supported in part by Roche Molecular Systems, Pleasanton, CA. Address reprint requests to Ms Erali: ARUP Institute for Clinical and Experimental Pathology, 500 Chipeta Way, Salt Lake City, UT Acknowledgments: We thank Stewart Wood for technical assistance. References 1. Simmonds P, McOmish F, Yap PL, et al. Sequence variability in the 5 non-coding region of hepatitis C virus: identification of a new virus type and restrictions on sequence diversity. J Gen Virol. 199;74: Simmonds P, Mellor J, Sakuldamrongpanich T, et al. Evolutionary analysis of variants of hepatitis C virus found in South-East Asia: comparison with classifications based upon sequence similarity. J Gen Virol. 1996;77: National Institutes of Health Consensus Development Conference Panel statement: management of hepatitis C. Hepatology. 1997;26(suppl 1):2S-10S. 4. Hawkins A, Davidson F, Simmonds P. Comparison of plasma virus loads among individuals infected with hepatitis C virus (HCV) genotypes 1, 2, and by Quantiplex HCV RNA assay versions 1 and 2, Roche Monitor assay, and an in-house limiting dilution method. J Clin Microbiol. 1997;5: Jacob S, Baudy D, Jones E, et al. Comparison of quantitative HCV RNA assays in chronic hepatitis C. Am J Clin Pathol. 1997;107: Lunel F, Cresta P, Vitour D, et al. Comparative evaluation of hepatitis C virus RNA quantitation by branched DNA, NASBA, and monitor assays. Hepatology. 1999;29: Trabaud M-A, Bailly F, Si-Ahmed SN, et al. Comparison of HCV RNA assays for the detection and quantification of hepatitis C virus RNA levels in serum of patients with chronic hepatitis C treated with interferon. J Med Virol. 1997;52: Am J Clin Pathol 2000;114: American Society of Clinical Pathologists
8 Clinical Chemistry / ORIGINAL ARTICLE 8. McHutchison JG, Gordon SC, Schiff ER, et al. Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. N Engl J Med. 1998;9: Davis GL, Lau JYN. Factors predictive of a beneficial response to therapy of hepatitis C. Hepatology. 1997;26(suppl 1):122S-127S. 10. Mahaney K, Tedeschi V, Maertens G, et al. Genotypic analysis of hepatitis C virus in American patients. Hepatology. 1994;20: Orito E, Mizokami M, Nakano T, et al. Serum hepatitis C virus RNA level as a predictor of subsequent response to interferon-alpha therapy in Japanese patients with chronic hepatitis C. J Med Virol. 1994;44: Tong CYW, Hollingsworth RC, Williams H, et al. Effect of genotypes on the quantification of hepatitis C virus (HCV) RNA in clinical samples using the Amplicor HCV Monitor Test and the Quantiplex HCV RNA 2.0 Assay (bdna). J Med Virol. 1998;55: Mellor J, Hawkins A, Simmonds P. Genotype dependence of hepatitis C virus load measurement in commercially available quantitative assays. J Clin Microbiol. 1999;7: Tong MJ, Blatt LM, McHutchison JG, et al. Prediction of response during interferon alfa 2b therapy in chronic hepatitis C patients using viral and biochemical characteristics: a comparison. Hepatology. 1997;26: Saldanha J, Lelie N, Heath A, and the WHO Collaborative Study Group. Establishment of the first international standard for nucleic acid amplification technology (NAT) assays for HCV RNA. Vox Sang. 1999;76: American Society of Clinical Pathologists Am J Clin Pathol 2000;114:
Technical Bulletin No. 162
CPAL Central Pennsylvania Alliance Laboratory Technical Bulletin No. 162 cobas 6800 HCV Viral Load Assay - New Platform - June 1, 2017 Contact: Heather Habig, MLS (ASCP) CM, MB CM, 717-851-1422 Operations
More informationPerformance of an automated system for quantification of hepatitis C virus RNA
Journal of Virological Methods 86 (2000) 55 60 www.elsevier.com/locate/jviromet Performance of an automated system for quantification of hepatitis C virus RNA Anne Marie Roque Afonso a, *, Josiane Didier
More informationTechnical Bulletin No. 161
CPAL Central Pennsylvania Alliance Laboratory Technical Bulletin No. 161 cobas 6800 HIV-1 Viral Load Assay - New Platform - June 1, 2017 Contact: Heather Habig, MLS (ASCP) CM, MB CM, 717-851-1422 Operations
More informationPapers. Clinical application of the Quantiplex HCV RNA 2.0 and Amplicor HCV Monitor assays for quantifying serum hepatitis C virus RNA
J Clin Pathol 1999;52:807 811 807 Papers Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical College Hospital, No 100, Shih-Chuan 1st Rd, Kaohsiung, Taiwan, Republic of China M-L
More informationCALIBRATION OF ANALYTICAL STANDARDS FOR HBV-DNA, HCV-RNA AND HIV-1 RNA IN GENOME COPIES BY A REFERENCE METHOD
CALIBRATION OF ANALYTICAL STANDARDS FOR HBV-DNA, HCV-RNA AND HIV-1 RNA IN GENOME COPIES BY A REFERENCE METHOD AAJ van Drimmelen, E.R. Bax and W.G.V. Quint, BioQControl (BQC), Delft Diagnostic Laboratories
More informationMolecular Diagnosis Future Directions
Molecular Diagnosis Future Directions Philip Cunningham NSW State Reference Laboratory for HIV/AIDS & Molecular Diagnostic Medicine Laboratory, SydPath St Vincent s Hospital Sydney Update on Molecular
More informationComparison of Quantitative HCV RNA Assays in Chronic Hepatitis C
MICROBIOLOGY AND INFECTIOUS DISEASE Original Article Comparison of Quantitative HCV RNA Assays in Chronic Hepatitis C SHERAJ JACOB, MD, DEBORAH BAUDY, ELIZABETH JONES, LIZHE XU, PhD, ANDREW MASON, MBBS,
More informationLaboratory for Clinical and Biological Studies, University of Miami Miller School of Medicine, Miami, FL, USA.
000000 00000 0000 000 00 0 bdna () 00000 0000 000 00 0 Nuclisens () 000 00 0 000000 00000 0000 000 00 0 Amplicor () Comparison of Amplicor HIV- monitor Test, NucliSens HIV- QT and bdna Versant HIV RNA
More informationDiagnostic Methods of HBV infection. Zohreh Sharifi,ph.D of Virology Research center, Iranian Blood Transfusion Organization (IBTO)
Diagnostic Methods of HBV infection Zohreh Sharifi,ph.D of Virology Research center, Iranian Blood Transfusion Organization (IBTO) Hepatitis B-laboratory diagnosis Detection of HBV infection involves
More informationHuman diagnostics. Better be Sure: Quantify HDV & HBV viral load. RoboGene product family
Human diagnostics Better be Sure: Quantify HDV & HBV viral load. RoboGene product family 2 RoboGene Product Family Improved patient management: Standardized monitoring of HBV DNA and HDV RNA viral load.
More informationCMV DNA Quantification Using an Automated Platform for Nucleic Acid Extraction and Real- time PCR Assay Set-up
JCM Accepts, published online ahead of print on 11 May 2011 J. Clin. Microbiol. doi:10.1128/jcm.00721-11 Copyright 2011, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 48) Number: PQDx 0126-046-00 Abstract The COBAS AmpliPrep/COBAS TaqMan
More informationHEPATITIS C VIRUS GENOTYPING IN CHRONIC HEPATITIS C PATIENTS
HEPATITIS C VIRUS GENOTYPING IN CHRONIC HEPATITIS C PATIENTS I. Qattan Centres for Hepatology, Royal Free & University College Medical School, London V. Emery Department of Virology, Royal Free & University
More informationGenotype Dependence of Hepatitis C Virus Load Measurement in Commercially Available Quantitative Assays
JOURNAL OF CLINICAL MICROBIOLOGY, Aug. 1999, p. 2525 2532 Vol. 37, No. 8 0095-1137/99/$04.00 0 Copyright 1999, American Society for Microbiology. All Rights Reserved. Genotype Dependence of Hepatitis C
More informationHIV-1 Viral Load Real Time (RG)
-1 Viral Load Real Time (RG) Real Time RT-PCR type 1 RNA quantification assay MSP Reg. pending Valdense 3616. 11700. Montevideo. Uruguay. phone (598) 2 336 83 01. Fax (598) 2 336 71 60. Info@atgen.com.uy
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT. Product: VERSANT HIV-1 RNA 1.0 Assay (kpcr) Number: PQDx
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: VERSANT HIV-1 RNA 1.0 Assay (kpcr) Number: PQDx 0115-041-00 Abstract The VERSANT HIV-1 RNA 1.0 Assay (kpcr) with product codes 10375763,
More informationInstructions for Use. RealStar Influenza Screen & Type RT-PCR Kit /2017 EN
Instructions for Use RealStar Influenza Screen & Type RT-PCR Kit 4.0 05/2017 EN RealStar Influenza Screen & Type RT-PCR Kit 4.0 For research use only! (RUO) 164003 INS-164000-EN-S01 96 05 2017 altona
More informationWHO Prequalification of In Vitro Diagnostics PUBLIC REPORT. Product: Alere q HIV-1/2 Detect WHO reference number: PQDx
WHO Prequalification of In Vitro Diagnostics PUBLIC REPORT Product: Alere q HIV-1/2 Detect WHO reference number: PQDx 0226-032-00 Alere q HIV-1/2 Detect with product codes 270110050, 270110010 and 270300001,
More informationDiagnostic Methods of HBV and HDV infections
Diagnostic Methods of HBV and HDV infections Zohreh Sharifi,ph.D Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine Hepatitis B-laboratory diagnosis Detection
More informationStrengths and Limitations of Commercial Tests for Hepatitis C Virus RNA Quantification
JOURNAL OF CLINICAL MICROBIOLOGY, Jan. 2004, p. 421 425 Vol. 42, No. 1 0095-1137/04/$08.00 0 DOI: 10.1128/JCM.42.1.421 425.2004 Copyright 2004, American Society for Microbiology. All Rights Reserved. Strengths
More informationPhosphate buffered saline (PBS) for washing the cells TE buffer (nuclease-free) ph 7.5 for use with the PrimePCR Reverse Transcription Control Assay
Catalog # Description 172-5080 SingleShot Cell Lysis Kit, 100 x 50 µl reactions 172-5081 SingleShot Cell Lysis Kit, 500 x 50 µl reactions For research purposes only. Introduction The SingleShot Cell Lysis
More informationPanther has new prey
Raising the Bar for Performance Testing Panther has new prey The Aptima HIV-1 Quant Dx assay leads the hunt for HIV-1 diagnosis and viral load monitoring. Freedom to work the way you choose Run what assays
More informationaltona RealStar Instructions for Use RealStar CMV PCR Kit /2017 EN DIAGNOSTICS
altona DIAGNOSTICS Instructions for Use RealStar CMV PCR Kit 1.2 08/2017 EN RealStar RealStar CMV PCR Kit 1.2 For research use only! (RUO) 021202 INS-021200-EN-S01 48 08 2017 altona Diagnostics GmbH Mörkenstr.
More informationTrends in molecular diagnostics
Trends in molecular diagnostics Detection of target genes of interest Quantification Infectious diseases HIV Hepatitis C & B TB / MAC Cytomegalovirus Herpes simplex Varicella zoster CT/GC HPV Profiling
More informationInstructions for Use. RealStar Influenza S&T RT-PCR Kit /2017 EN
Instructions for Use RealStar Influenza S&T RT-PCR Kit 3.0 01/2017 EN RealStar Influenza S&T RT-PCR Kit 3.0 For research use only! (RUO) 163003 INS-163000-EN-S02 96 01 2017 altona Diagnostics GmbH Mörkenstr.
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT. Product: Abbott RealTime HIV-1 (m2000sp) Number: PQDx
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: Abbott RealTime HIV-1 (m2000sp) Number: PQDx 0145-027-00 Abstract Abbott RealTime HIV-1 (m2000sp) assay with product code 2G31, which
More informationQuantification of HBV, HCV genotype and HIV subtype panels
Quantification of HBV, HCV genotype and HIV subtype panels Harry van Drimmelen 1,2, Wim Quint 2, Nico Lelie 3 and the international NAT study group 1. Biologicals Quality Control, 2. DDL Diagnostic Laboratory,
More informationProduct # Kit Components
3430 Schmon Parkway Thorold, ON, Canada L2V 4Y6 Phone: (905) 227-8848 Fax: (905) 227-1061 Email: techsupport@norgenbiotek.com Pneumocystis jirovecii PCR Kit Product # 42820 Product Insert Background Information
More informationRoche Molecular Biochemicals Application Note No. HP 1/1999
Roche Molecular Biochemicals Application Note No. HP 1/1999 Nucleic Acid Purification High Pure Viral Nucleic Acid Kit High Pure 16 System Viral Nucleic Acid Kit Efficiency of Hepatitis C Virus sample
More informationP0141 HBV 1000 copies/ml genotype reference panel
P0141 HBV 1000 copies/ml genotype reference panel P0141 The kit insert contains a detailed protocol and should be read carefully before testing the run control to ensure optimal performance Table of contents
More informationHuman Rotavirus A. genesig Standard Kit. Non structural protein 5 (NSP5) 150 tests. Primerdesign Ltd. For general laboratory and research use only
TM Primerdesign Ltd Human Rotavirus A Non structural protein 5 (NSP5) genesig Standard Kit 150 tests For general laboratory and research use only 1 Introduction to Human Rotavirus A Rotavirus is a genus
More informationComparison of Three Roche HBV Viral Load Assay Formats
JCM Accepts, published online ahead of print on 25 April 2012 J. Clin. Microbiol. doi:10.1128/jcm.00746-12 Copyright 2012, American Society for Microbiology. All Rights Reserved. 1 Title 2 3 4 5 6 7 8
More informationHuman Rotavirus A. genesig Advanced Kit. Non structural protein 5 (NSP5) 150 tests. Primerdesign Ltd. For general laboratory and research use only
TM Primerdesign Ltd Human Rotavirus A Non structural protein 5 (NSP5) genesig Advanced Kit 150 tests For general laboratory and research use only 1 Introduction to Human Rotavirus A Rotavirus is a genus
More informationNorgen s HIV proviral DNA PCR Kit was developed and validated to be used with the following PCR instruments: Qiagen Rotor-Gene Q BioRad icycler
3430 Schmon Parkway Thorold, ON, Canada L2V 4Y6 Phone: (905) 227-8848 Fax: (905) 227-1061 Email: techsupport@norgenbiotek.com HIV Proviral DNA PCR Kit Product # 33840 Product Insert Background Information
More informationNorgen s HIV Proviral DNA PCR Kit was developed and validated to be used with the following PCR instruments: Qiagen Rotor-Gene Q BioRad T1000 Cycler
3430 Schmon Parkway Thorold, ON, Canada L2V 4Y6 Phone: 866-667-4362 (905) 227-8848 Fax: (905) 227-1061 Email: techsupport@norgenbiotek.com HIV Proviral DNA PCR Kit Product# 33840 Product Insert Intended
More informationW ith an estimated million people worldwide
141 ORIGINAL ARTICLE Clinical evaluation of the COBAS Amplicor HBV monitor test for measuring serum HBV DNA and comparison with the Quantiplex branched DNA signal amplification assay in Taiwan C-Y Dai,
More informationIntroduction: Table/Figure Descriptions:
Introduction: We have completed the analysis of your HIV RNA Validation Study. The validation plan was designed to verify the installation of an unmodified FDA-approved HIV RNA assay into your laboratory.
More informationStability of native, lyophilized and inactivated standards
Stability of native, lyophilized and inactivated standards Harry van Drimmelen Bio Quality Control, Heiloo, Netherlands Satellite Meeting before IPFA-PEI 25 th Workshop Twenty-five Years Standardization
More informationRotavirus A. genesig Standard Kit. DNA testing. Everything... Everyone... Everywhere... Non structural protein 5 (NSP5) 150 tests.
TM Primerdesign Ltd TM Primerdesign Ltd Rotavirus A Non structural protein 5 (NSP5) genesig Standard Kit 150 tests DNA testing Everything... Everyone... Everywhere... For general laboratory and research
More informationFor Research Use Only Ver
INSTRUCTION MANUAL Quick-RNA Viral Kit Catalog Nos. R1034 & R1035 Highlights Quick, spin-column purification of viral RNA from plasma, serum, CSF, cell culture media, cellular suspensions, urine, blood,
More informationAIDS - Knowledge and Dogma. Conditions for the Emergence and Decline of Scientific Theories Congress, July 16/ , Vienna, Austria
AIDS - Knowledge and Dogma Conditions for the Emergence and Decline of Scientific Theories Congress, July 16/17 2010, Vienna, Austria Reliability of PCR to detect genetic sequences from HIV Juan Manuel
More informationStandardization of Hepatitis C Virus RNA Quantification
Standardization of Hepatitis C Virus RNA Quantification JEAN-MICHEL PAWLOTSKY, 1,2 MAGALI BOUVIER-ALIAS, 1 CHRISTOPHE HEZODE, 3 FRANCOISE DARTHUY, 1 JOCELYNE REMIRE, 1 AND DANIEL DHUMEAUX 2,3 It was recently
More informationFor purification of viral DNA and RNA from a wide range of sample materials
QIAamp virus kits For purification of viral DNA and RNA from a wide range of sample materials Automatable on QIAGEN s proven QIAamp Kits set the standard for purification of viral DNA and RNA. QIAamp virus
More informationHuman influenza A virus subtype (H1)
PCRmax Ltd TM qpcr test Human influenza A virus subtype (H1) Haemoglutinin H1 gene 150 tests For general laboratory and research use only 1 Introduction to Human influenza A virus subtype (H1) Influenza,
More informationcobas TaqScreen West Nile Virus Test for use on the cobas s 201 system
cobas TaqScreen West Nile Virus Test for use on the cobas s 201 system FOR IN VITRO DIAGNOSTIC USE. cobas TaqScreen West Nile Virus Test WNV 96 Tests P/N: 04741722 190 cobas TaqScreen West Nile Virus Control
More informationHuman Immunodeficiency Virus type 1 (HIV-1) gp120 / Glycoprotein 120 ELISA Pair Set
Human Immunodeficiency Virus type 1 (HIV-1) gp120 / Glycoprotein 120 ELISA Pair Set Catalog Number : SEK11233 To achieve the best assay results, this manual must be read carefully before using this product
More informationAli Alabbadi. Bann. Bann. Dr. Belal
31 Ali Alabbadi Bann Bann Dr. Belal Topics to be discussed in this sheet: Particles-to-PFU Single-step and multi-step growth cycles Multiplicity of infection (MOI) Physical measurements of virus particles
More information(DNA) Real-time PCR. Exicycler 96 Rotor-Gene Q/6000 PCR
Real-Time (DNA) Real-time Exicycler 96 Rotor-Gene Q/6000 IU Mix1 Mix2 IU/μl IU/μl IU/μl IU/μl IU/μl IPC NTC C 1 Lot# 2 Freeze & thawing 1 MSDS: Material Safety Data Sheets (TaqMan Real-time ' FAM ' BHQ1
More informationACTG Laboratory Technologist Committee Version 2.0 ACTG Lab Man UltraSensitive Roche Monitor Test, v1.5- MWP 18 May 2004
1. PRINCIPLE UltraSensitive Roche Monitor Test, v1.5- MWP 1.1 Name and Intended Use 1.1.1 The AMPLICOR HIV-1 MONITOR test version 1.5 is an in vitro nucleic acid amplification test for the quantitation
More informationTriiodothyronine (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 informationon October 4, 2018 by guest
JCM Accepts, published online ahead of print on 3 July 2012 J. Clin. Microbiol. doi:10.1128/jcm.01249-12 Copyright 2012, American Society for Microbiology. All Rights Reserved. 1 Title: Performance of
More informationMouse C3 (Complement Factor 3) ELISA Kit
Mouse C3 (Complement Factor 3) ELISA Kit Cat. No.:DEIA8289 Pkg.Size:96T Intended use The Mouse C3 (Complement Factor 3) ELISA Kit is a highly sensitive two-site enzyme linked immunoassay (ELISA) for measuring
More informationKit Components Product # EP42720 (24 preps) MDx 2X PCR Master Mix 350 µl Cryptococcus neoformans Primer Mix 70 µl Cryptococcus neoformans Positive
3430 Schmon Parkway Thorold, ON, Canada L2V 4Y6 Phone: 866-667-4362 (905) 227-8848 Fax: (905) 227-1061 Email: techsupport@norgenbiotek.com Cryptococcus neoformans End-Point PCR Kit Product# EP42720 Product
More informationSerum Amyloid A ELISA
Serum Amyloid A ELISA For the quantitative determination of serum amyloid A (SAA) in serum plasma For Research use Only. Not for Use in Diagnostic Procedures Please see Appendix A for Reference Serum information
More informationHuman Rotavirus B. Non structural protein 5 (NSP5) 150 tests. Quantification of Human Rotavirus B genomes Advanced kit handbook HB10.01.
PCR Max Ltd TM qpcr test Human Rotavirus B Non structural protein 5 (NSP5) 150 tests For general laboratory and research use only 1 Introduction to Human Rotavirus B Rotavirus is a genus of double-stranded
More informationFor in vitro Veterinary Diagnostics only. Kylt Rotavirus A. Real-Time RT-PCR Detection.
For in vitro Veterinary Diagnostics only. Kylt Rotavirus A Real-Time RT-PCR Detection www.kylt.eu DIRECTION FOR USE Kylt Rotavirus A Real-Time RT-PCR Detection A. General Kylt Rotavirus A products are
More informationE.Z.N.A. SQ Blood DNA Kit II. Table of Contents
E.Z.N.A. SQ Blood DNA Kit II Table of Contents Introduction and Overview...2 Kit Contents/Storage and Stability...3 Blood Storage and DNA Yield...4 Preparing Reagents...5 100-500 μl Whole Blood Protocol...6
More informationSwine H1N1 Influenza Human Pandemic Strain
Techne qpcr test Swine H1N1 Influenza Human Pandemic Strain M1 - global Influenza A & N1- specific for Swine H1N1 Influenza Human Pandemic Strain 150 tests For general laboratory and research use only
More informationA Genotype-Independent Real-Time PCR Assay for Quantification of Hepatitis B Virus DNA
JOURNAL OF CLINICAL MICROBIOLOGY, Feb. 2007, p. 553 558 Vol. 45, No. 2 0095-1137/07/$08.00 0 doi:10.1128/jcm.00709-06 Copyright 2007, American Society for Microbiology. All Rights Reserved. A Genotype-Independent
More informationExperience with Standardisation of Blood Virology NAT. Clare Morris Division of Retrovirology National Institute for Biological Standards and Control
Experience with Standardisation of Blood Virology NAT Clare Morris Division of Retrovirology National Institute for Biological Standards and Control Background of Blood Virology Standardisation In the
More informationCotinine (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 informationPelagia Research Library. European Journal of Experimental Biology, 2015, 5(10):1-5
Available online at www.pelagiaresearchlibrary.com European Journal of Experimental Biology, 2015, 5(10):1-5 ISSN: 2248 9215 CODEN (USA): EJEBAU Molecular diagnosis of human immuno deficiency virus (HIV)
More informationAPOB (Human) ELISA Kit
APOB (Human) ELISA Kit Catalog Number KA4330 96 assays Version: 01 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Background... 3 Principle of the Assay...
More informationFully automated quantification of hepatitis C virus (HCV) RNA in human plasma and human serum by the COBAS AmpliPrep/COBAS TaqMan System,
Journal of Clinical Virology 38 (2007) 326 333 Fully automated quantification of hepatitis C virus (HCV) RNA in human plasma and human serum by the COBAS AmpliPrep/COBAS TaqMan System, Dorothea Sizmann,
More informationHbA1c (Human) ELISA Kit
HbA1c (Human) ELISA Kit Cat. No.:DEIA3509 Pkg.Size:96T Intended use GHbA1c (Human) ELISA Kit is a sandwich enzyme immunoassay for the quantitative measurement of human GHbA1c. General Description vhemoglobin,
More informationIntroduction to the Impact of Resistance in Hepatitis C
Introduction to the Impact of Resistance in Hepatitis C Sponsored by AbbVie 2/1/2017 Presented by Sammy Saab, MD, MPH, FACG, AGAF, FAASLD February 1 st, 2017 1 AbbVie disclosures This is an Abbvie sponsored
More informationDATA SHEET. Provided: 500 µl of 5.6 mm Tris HCl, 4.4 mm Tris base, 0.05% sodium azide 0.1 mm EDTA, 5 mg/liter calf thymus DNA.
Viral Load DNA >> Standard PCR standard 0 Copies Catalog Number: 1122 Lot Number: 150298 Release Category: A Provided: 500 µl of 5.6 mm Tris HCl, 4.4 mm Tris base, 0.05% sodium azide 0.1 mm EDTA, 5 mg/liter
More informationReceived 6 January 1995/Returned for modification 23 February 1995/Accepted 13 March 1995
JOURNAL OF CLINICAL MICROBIOLOGY, June 1995, p. 1562 1566 Vol. 33, No. 6 0095-1137/95/$04.00 0 Copyright 1995, American Society for Microbiology Comparative Stabilities of Quantitative Human Immunodeficiency
More informationRetro-X qrt-pcr Titration Kit User Manual
Takara Bio USA Retro-X qrt-pcr Titration Kit User Manual Cat. No. 631453 PT3952-1 (030218) 1290 Terra Bella Avenue, Mountain View, CA 94043, USA U.S. Technical Support: techus@takarabio.com United States/Canada
More informationPerformance of Version 2.0 of the Cobas AmpliPrep/Cobas TaqMan Real-Time PCR Assay for Hepatitis B Virus DNA Quantification
JOURNAL OF CLINICAL MICROBIOLOGY, Oct. 2010, p. 3641 3647 Vol. 48, No. 10 0095-1137/10/$12.00 doi:10.1128/jcm.01306-10 Copyright 2010, American Society for Microbiology. All Rights Reserved. Performance
More informationHuman Immunodeficiency Virus type 1 (HIV-1) p24 / Capsid Protein p24 ELISA Pair Set
Human Immunodeficiency Virus type 1 (HIV-1) p24 / Capsid Protein p24 ELISA Pair Set Catalog Number : SEK11695 To achieve the best assay results, this manual must be read carefully before using this product
More informationStandard Roche Monitor Test, v1.5- Boom Extraction
1. PRINCIPLE: Standard Roche Monitor Test, v1.5- Boom Extraction 1.1 Name and Intended Use The AMPLICOR HIV-1 MONITOR test is an in vitro nucleic acid amplification test for the quantitation of Human Immunodeficiency
More informationA multi-center clinical study comparing Sansure Magb and CAP/CTM HBV tests in the quantitative detection of HBV DNA
Original Article A multi-center clinical study comparing Sansure Magb and CAP/CTM HBV tests in the quantitative detection of HBV DNA Xiaoyu Fu 1,Deming Tan 1, Xiaoguang Dou 2,Jinjun Chen 3,Juan Wu 1 1
More informationcobas HBV Quantitative nucleic acid test for use on the cobas 4800 System For in vitro diagnostic use 240 Tests 960 Tests 240 Tests 960 Tests
Quantitative nucleic acid test for use on the cobas 4800 System For in vitro diagnostic use cobas HBV 120 Tests P/N: 06979564190 cobas HBV/HCV/HIV-1 Control Kit 10 Sets P/N: 06979572190 cobas 4800 System
More informationHepatitis B Virus Genemer
Product Manual Hepatitis B Virus Genemer Primer Pair for amplification of HBV Viral Specific Fragment Catalog No.: 60-2007-10 Store at 20 o C For research use only. Not for use in diagnostic procedures
More informationIdentification of Microbes Lecture: 12
Diagnostic Microbiology Identification of Microbes Lecture: 12 Electron Microscopy 106 virus particles per ml required for visualization, 50,000-60,000 magnification normally used. Viruses may be detected
More informationAvian influenza A virus subtype (H5)
TM Primerdesign Ltd Avian influenza A virus subtype (H5) Haemoglutinin H5 gene genesig Standard Kit 150 tests For general laboratory and research use only 1 Introduction to Avian influenza A virus subtype
More informationSupplemental Materials and Methods Plasmids and viruses Quantitative Reverse Transcription PCR Generation of molecular standard for quantitative PCR
Supplemental Materials and Methods Plasmids and viruses To generate pseudotyped viruses, the previously described recombinant plasmids pnl4-3-δnef-gfp or pnl4-3-δ6-drgfp and a vector expressing HIV-1 X4
More informationComparison of Five Automated Serum and Whole Blood Folate Assays
Clinical Chemistry / FIVE AUTOMATED FOLATE ASSAYS Comparison of Five Automated Serum and Whole Blood Folate Assays William E. Owen, MT(ASCP), 1 and William L. Roberts, MD, PhD 2 Key Words: Hemolysate;
More informationJOURNAL OF CLINICAL MICROBIOLOGY, Nov. 2000, p Vol. 38, No. 11. Copyright 2000, American Society for Microbiology. All Rights Reserved.
JOURNAL OF CLINICAL MICROBIOLOGY, Nov. 2000, p. 4171 4179 Vol. 38, No. 11 0095-1137/00/$04.00 0 Copyright 2000, American Society for Microbiology. All Rights Reserved. Improved Version 2.0 Qualitative
More informationAmpliX HBV Quantitative
Instructions for use REAL TIME PCR DETECTION AND QUANTITATION KIT OF HEPATITIS B VIRUS DNA Research Use Only (RUO) (Lyo-format) VBD0595 96 rcs valid from May 2013 Explanation of symbols used in labeling
More informationHepatitis C virus (HCV) is a major cause of posttransfusion
Molecular Testing in the Diagnosis and Management of Hepatitis C Virus Infection Raymond P. Podzorski, PhD Objectives. To review hepatitis C virus (HCV), describe the types of molecular-based tests available
More informationVirological Tools and Monitoring in the DAA Era
Virological Tools and Monitoring in the DAA Era Prof. Jean-Michel Pawlotsky, MD, PhD National Reference Center for Viral Hepatitis B, C and delta Department of Virology & INSERM U955 Henri Mondor Hospital
More informationRealLine HIV quantitative Str-Format
Instructions for use DETECTION AND QUANTIFICATION OF THE HUMAN IMMUNODEFICIENCY VIRUS RNA BY REAL TIME PCR Research Use Only (RUO) Attention! Please read the information about quantification process carefully!
More informationHuman Rotavirus C. genesig Advanced Kit. DNA testing. Everything... Everyone... Everywhere... Non structural protein 5 (NSP5) 150 tests
TM Primerdesign Ltd TM Primerdesign Ltd Human Rotavirus C Non structural protein 5 (NSP5) genesig Advanced Kit 150 tests DNA testing Everything... Everyone... Everywhere... For general laboratory and research
More informationHuman influenza A virus subtype (H3)
PCRmax Ltd TM qpcr test Human influenza A virus subtype (H3) Haemoglutinin H3 gene 150 tests For general laboratory and research use only 1 Introduction to Human influenza A virus subtype (H3) Influenza,
More informationAvian Influenza A H5N8
TM Primerdesign Ltd Avian Influenza A H5N8 Hemagglutinin (HA) gene & Neuraminidase (NA) gene genesig Standard Kit 150 tests For general laboratory and research use only 1 Introduction to Avian Influenza
More informationLaboratory and Clinical Diagnosis of HCV Infection
Laboratory and Clinical Diagnosis of HCV Infection Jean-Michel Pawlotsky,, MD, PhD Department of Virology (EA 3489) Henri Mondor Hospital University of Paris XII Créteil,, France I Nonspecific Liver Tests
More informationIntroduction to Cladosporium_spp
Techne qpcr test Cladosporium_spp 150 tests For general laboratory and research use only 1 Introduction to Cladosporium_spp Cladosporium is a genus of slow growing fungi, colonies are mostly dark green
More informationHIV-RNA reference panels
The kit insert contains a detailed protocol and should be read carefully before testing the run control to ensure optimal performance Table of contents Overview HIV-RNA panels for sensitivity analysis...
More informationInterferon and ribavirin therapy for chronic hepatitis C virus genotype 6: A comparison with genotype 1
Title Interferon and ribavirin therapy for chronic hepatitis C virus genotype 6: A comparison with genotype 1 Author(s) Hui, CK; Yuen, MF; Sablon, E; Chan, AOO; Wong, BCY; Lai, CL Citation Journal Of Infectious
More informationACTG Laboratory Technologist Committee Version 1.0 ACTG Lab Man UltraSensitive Roche Monitor Test, v1.5- Boom Extraction 26 April 2004
1. PRINCIPLE: UltraSensitive Roche Monitor Test, v1.5- Boom Extraction 1.1 Name and Intended Use The AMPLICOR HIV-1 MONITOR test is an in vitro nucleic acid amplification test for the quantitation of Human
More informationFor Research Use Only Ver
INSTRUCTION MANUAL Quick-DNA/RNA Viral MagBead Catalog Nos. R2140 & R2141 Highlights High-throughput, magnetic-bead based purification of viral DNA and RNA from plasma, serum, urine, cell culture media,
More informationTNF-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 informationHBV-DNA reference panels
HBV-DNA reference panels The kit insert contains a detailed protocol and should be read carefully before testing the run control to ensure optimal performance Table of contents Overview HBV-DNA panels
More informationSupplemental Figure 1 ELISA scheme to measure plasma total, mature and furin-cleaved
1 Supplemental Figure Legends Supplemental Figure 1 ELISA scheme to measure plasma total, mature and furin-cleaved PCSK9 concentrations. 4 Plasma mature and furin-cleaved PCSK9s were measured by a sandwich
More informationHBV PUBLIC HEALTH IMPLICATIONS
جزايری دکتر سيد محمد آزمايشگاه ھپاتيت B -دانشکده بھداشت ويروس شناسی- گروه دانشگاه علوم پزشکی تھران کنگره ارتقا کيفيت- ١٣٩٢ HBV PUBLIC HEALTH IMPLICATIONS 2 billion people have been infected by HBV worldwide.
More informationCEPHIA Consortium for the Evaluation and Performance of HIV Incidence Assays STANDARD OPERATING PROCEDURE
CEPHIA Consortium for the Evaluation and Performance of HIV Incidence Assays STANDARD OPERATING PROCEDURE TITLE : SOP for (off board dilution) Less Sensitive Modified VITROS Enzyme Immunoassay CEPHIA DOCUMENT
More informationInfluenza A H1N1 HA ELISA Pair Set
Influenza A H1N1 HA ELISA Pair Set for H1N1 ( A/Puerto Rico/8/1934 ) HA Catalog Number : SEK11684 To achieve the best assay results, this manual must be read carefully before using this product and the
More information