Unigold Recombigen HIV 1/2 Training for HIV Testing Sites. Updated: February 2018 Cicely Richard Office of HIV/AIDS
|
|
- Logan Mills
- 5 years ago
- Views:
Transcription
1 Unigold Recombigen HIV 1/2 Training for HIV Testing Sites Updated: February 2018 Cicely Richard Office of HIV/AIDS
2 Updated: February 2018 Cicely Richard Office of HIV/AIDS UNIGOLD RECOMBIGEN HIV 1/2 TRAINING FOR HIV TESTING SITES
3 Objective The objective of today s training is to become familiar with the Unigold Recombigen HIV 1/2 test. This is a 3 rd generation HIV antibody test. This testing device is currently utilized only by HIV testing sites that are approved to use the DPH rapid/rapid testing algorithm.
4 CLINICAL CHEMISTRY COAGULATION INFECTIOUS DISEASE POINT OF CARE Uni-Gold Recombigen HIV 1/2 Training Lou Pastors MT(ASCP National Account Manager Trinity Biotech Phone:
5 Uni-Gold Recombigen HIV NAME AND INTENDED USE Uni-Gold Recombigen HIV is a single use rapid immunoassay for the qualitative detection of antibodies to HIV-1 and /or HIV-2 in serum, plasma and whole blood (venipuncture and fingerstick). Uni-Gold Recombigen HIV is intended for use in point of care settings as an aid in diagnosis of infection with HIV-1 and HIV-2. * Uni-Gold Recombigen HIV Package Insert, pg. 1 5
6 HIV Antibodies 6
7 Rapid HIV-1 Screen Performance Data Review Manufacturer Performance Data from the four available CLIA Waived Rapid HIV-1 Tests when used with a Whole Blood Sample. Sensitivity Specificity Uni-Gold 100% 99.7% Clearview Sure Check 99.7% 99.9% Determine HIV Ag/Ab Combo 4 th Generation 99.9% 99.7% OraQuick Advance 99.5% 100% 7
8 Uni-Gold Recombigen HIV 1/2 Kit General Kit Information 20 Tests Devices per Kit Kit Storage at 35.6 to 80.6 F 12 month expiration from DOM Record Received Date on each Box Product Number:
9 Uni-Gold Recombigen HIV 1/2 Kit Each Kit Contains: 20 Test Devices 1 Vial of Wash Solution 20 Disposable Pipettes 20 Fingerstick Collection Devices 20 Subject Information Leaflets 1 Package Insert 9
10 Please note the Unigold pipettes are NOT the same as the INSTI pipetts. The specimen amount required is different. Pipette Comparison Pipettes can not be interchanged.
11 Uni-Gold Recombigen HIV 1/2 Controls Each Set of Controls Contains: 1 Vial of Positive HIV-1 Control O.5mL 1 Vial of Positive HIV-2 Control 0.5mL 1 Vial of Negative HIV Control 0.5mL 1 Package Insert Always Store at 2⁰ to 8⁰ C 12 Month Expiration from DOM Open Vial Stability is One Month Product Number:
12 Uni-Gold Rapid HIV Fingerstick Procedure Materials required for Uni-Gold Fingerstick Procedure Uni-Gold Test Device (Room Temp, 20 Minutes stored at 2-8 C) Uni-Gold Wash Solution (blue top dropper provided in Kit) Uni-Gold Fingerstick Collection Device (provided in Kit) Uni-Gold Subject Information Leaflet (provided in Kit) Lancet* (Any Blade Lancet Capable of a 50 µl Bleed) Sterile Gauze*, Alcohol Wipe*, and Band Aid* Latex Gloves* Marker/Sharpie* Biohazard Container* Sharps Container* Timer* (Timers provided by Trinity Biotech upon request) *Materials required but not provided with Uni-Gold Kit 12
13 Uni-Gold Rapid HIV Fingerstick Procedure Organize Materials required for Procedure Open a new Test Device and mark with Patient ID 13
14 Uni-Gold Rapid HIV Fingerstick Procedure Identify fingerstick location, clean the area with Alcohol Wipe, and allow to dry Make puncture with Lancet Wipe away the first drop of blood with a sterile gauze pad 14
15 Uni-Gold Rapid HIV Fingerstick Procedure Obtain a full drop of blood before starting the Collection 15
16 Uni-Gold Rapid HIV Fingerstick Procedure Holding the Fingerstick Collection Device horizontally Touch the tip of the Collection Device to the sample surface Fill the Fingerstick Collection Device to the black line Do NOT squeeze the bulb to collect the sample 16
17 Uni-Gold Rapid HIV Fingerstick Procedure Dispense the Sample into the Sample Port Squeezing the bulb to dispense the Sample Allow the sample to absorb into the membrane 17
18 Uni-Gold Rapid HIV Fingerstick Procedure Add 4 Drops of Wash Solution into the Sample Port Do not touch the sample port with the tip of the wash solution 18
19 Uni-Gold Rapid HIV Fingerstick Procedure After addition of the Wash Solution, set timer for 10 Minutes Read the test after 10 minutes and before 12 minutes 19
20 Uni-Gold Rapid HIV Fingerstick Procedure For a CLIA waived test result to be valid, there must be a control line present and full red color in the sample port Control Line Area Test Line Area Sample Port 20
21 Uni-Gold Rapid HIV Fingerstick Procedure Negative (Non-Reactive) Valid Test Result Control Line Present Test Line Absent Full Red color in the sample port. Preliminary Positive (Reactive) Valid Test Result Control Line Present Test Line Present Full Red color in the sample port. 21
22 Uni-Gold Quality Control (QC) Performance When do I need to run controls? Have I ever ran External Controls in the past? Has Anyone ran External Controls with this Lot Number? Has Anyone ran External Controls with this Shipment? Have the storage temperatures been acceptable? Am I in compliance with our Quality Assurance Guidelines? If the answer to any of the above is No, you will need to perform the external QC. 22
23 Uni-Gold Quality Control (QC) Performance Materials required for Uni-Gold HIV QC Performance Uni-Gold Recombigen HIV Kit Controls Uni-Gold Disposable Pipette Uni-Gold Test Devices (3) Uni-Gold Wash Solution Latex Gloves Marker/Sharpie Timer (use your watch or clock for today) Biohazard Container * Kit Controls are a separate product from Trinity Biotech (# ) 23
24 Uni-Gold Quality Control (QC) Performance Organize all materials required for External QC Performance Open new Test Devices (3) and Mark with QC ID (1+,2+, Neg) If the QC Vials are unopened, record date on vial/box 24
25 Uni-Gold Quality Control (QC) Performance Immerse the tip of the Disposable Pipette into the QC Vial GENTLY press on the bulb to draw a minimal amount of sample From vertical, dispense 1 free-falling Drop into the sample port Allow to absorb into the sample port 25
26 Uni-Gold Quality Control (QC) Performance Add 4 Drops of Wash Solution into the Sample Port Do not touch the sample port with the tip of the wash solution 26
27 Uni-Gold Quality Control (QC) Performance After addition of the wash solution, set timer for 10 Minutes Read test after 10 minutes and before 12 minutes 27
28 Uni-Gold HIV QC Performance Note Uni-Gold HIV Uni-Gold Venipuncture Procedure When using with fingerstick whole blood, full red color must appear in the sample port for the test to be valid Uni-Gold HIV Control Test Sample TRINITY BIOTECH Uni-Gold QC Determination When using with Uni-Gold External Kit Controls, the sample port will NOT have full red color. QC Determination is valid without the full red color in the sample port. Control Test Sample TRINITY BIOTECH 28
29 The link below is to an video demonstration of the UniGold Recombigen HIV 1/2 Fingerstick Procedure. Please note this is for use as a training guide only. The most current Instructions should always be reviewed prior to testing.
30 Thank you for participating in the Unigold Recombigen HIV 1/2 Training for HIV Testing Sites. Please direct any of your questions or concerns to your Regional Coordinator.
31 CLINICAL CHEMISTRY COAGULATION INFECTIOUS DISEASE POINT OF CARE Uni-Gold Recombigen HIV 1/2 Training Lou Pastors MT(ASCP National Account Manager Trinity Biotech Phone:
ANTIBODY SCREENING by Uni-Gold Recombigen HIV
ANTI-HIV SPECIMEN 1 REQUIREMENTS ANTIBODY SCREENING by Uni-Gold Recombigen HIV PRINCIPLE: The Uni-Gold Recombigen HIV was designed as a rapid immunoassay and is intended to detect antibodies to HIV- 1
More informationDETERMINE SPECIMEN REQUIREMENTS HIV-1/2 Ag/Ab Combo TESTING PROCEDURE
DETERMINE SPECIMEN REQUIREMENTS HIV-1/2 Ag/Ab Combo TESTING PROCEDURE PRINCIPLE: The Determine HIV-1/2 Ag/Ag Combo assay is a qualitative immunoassay for the simultaneous detection of Human Immunodeficiency
More informationStep-by-Step Instructions For OraQuick HCV Rapid Antibody Test
Step-by-Step Instructions For OraQuick HCV Rapid Antibody Test Complexity: WAIVED for fingerstick whole blood and venipuncture whole blood. A Certificate of CLIA Waiver is required to perform the test
More informationTo provide you with necessary knowledge and skills to accurately perform 3 HIV rapid tests and to determine HIV status.
Module 9 Performing HIV Rapid Tests Purpose To provide you with necessary knowledge and skills to accurately perform 3 HIV rapid tests and to determine HIV status. Pre-requisite Modules Module 3: Overview
More informationUni-Gold Recombigen HIV-1/2
Uni-Gold Recombigen 1206506 Pour d'autres langues Für andere Sprachen Para otras lenguas Per le altre lingue Dla innych języków Para outras línguas Για τις άλλες λώσσες För andra språk For andre språk
More informationQUICK REFERENCE INSTRUCTIONS. THYROCHEK TSH Cassette
QUICK REFERENCE INSTRUCTIONS THYROCHEK TSH Cassette A certificate of CLIA waiver is required to perform the testing in a waived setting. If the laboratory does not have a Certificate of Waiver, the Application
More informationONE-STEP WHOLE BLOOD H.PYLORI TEST. Product Code: 24529
ONE-STEP WHOLE BLOOD H.PYLORI TEST Product Code: 24529 Contents of Package: - Foil Package (Contains: Test Device and Dropper) - Vial of Test Solution - Finger Stick Device Alcohol Swab Materials required
More informationWHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT. Product: Uni-Gold HIV Number: PQDx Abstract
WHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT Product: Uni-Gold HIV Number: PQDx 0149-052-00 Abstract Uni-Gold HIV with product codes 1206502, 1206502N, 1206502E, 1206502N-100 manufactured
More informationTreponema Pallidum (TP) Antibody Test
Treponema Pallidum (TP) Antibody Test Instructions For Use Format: Cassette For: Catalog Number: VEL-001-TP Specimen: Serum/Plasma * Please read the instructions carefully before use INTENDED USE Velotest
More informationMalaria Pf/pan antigen Rapid Test
Malaria Pf/pan antigen Rapid Test Cat. No.:IVDTS003 Pkg.Size:10T/50T Intended use The Malaria Pf/pan antigen Rapid Test is a self-performing, qualitative, sandwich immunoassay, utilizing whole blood for
More informationHepatitis C Virus (HCV) Antibody Test
Hepatitis C Virus (HCV) Antibody Test Instructions For Use Format: Cassette For: Catalog Number: VEL-001-HCV Specimen: Serum/Plasma * Please read the instructions carefully before use INTENDED USE Hepatitis
More informationTips for Training New Customers
Tips for Training New Customers Good Habits: Test Strips Recap vial immediately and tightly after removing a single test strip. Never remove the desiccant from the vial. Do not lay test strips out ahead
More informationLeadCare BLOOD LEAD ANALYZER. Quick Reference Guide
LeadCare II BLOOD LEAD ANALYZER Quick Reference Guide Precautions Precautions Caution The LeadCare II Blood Lead Analyzer is a CLIA-waived device. Facilities that perform tests with the LeadCare II System
More informationRotavirus Test Kit. Instructions For Use. Format: Cassette Specimen: Fecal Extract Catalog Number: VEL-001-ROTA
Rotavirus Test Kit Instructions For Use Format: Cassette Specimen: Fecal Extract Catalog Number: VEL-001-ROTA * Please read the instructions carefully before use INTENDED USE Velotest Rotavirus Test is
More informationWHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT. Product: Uni-Gold HIV Number: PQDx Abstract
WHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT Product: Uni-Gold HIV Number: PQDx 0149-052-00 Abstract Uni-Gold HIV with product codes 1206502, 1206502N, 1206502E, 1206502N-100 manufactured
More informationCoaguChek S System. Quick Reference Guide. This is a CLIA-waived System. Coagulation Testing with Fresh Whole Blood
CoaguChek S System This is a CLIA-waived System Quick Reference Guide Coagulation Testing with Fresh Whole Blood May not print or view at 100% All unmarked prints black. Coag Swoosh prints gradients of
More informationA rapid test for the qualitative detection of Malaria pf and pv antigen in human blood sample
A rapid test for the qualitative detection of Malaria pf and pv antigen in human blood sample For in vitro use only Intended Use For the rapid qualitative determination of Malaria P. falciparum specific
More informationWHO Prequalification of In Vitro Diagnostics PUBLIC REPORT. Product: OraQuick HIV 1/2 Rapid Antibody Test WHO reference number: PQDx
WHO Prequalification of In Vitro Diagnostics PUBLIC REPORT Product: OraQuick HIV 1/2 Rapid Antibody Test WHO reference number: PQDx 0159-055-00 OraQuick HIV 1/2 Rapid Antibody Test with product codes 5x4-0010
More informationChlamydia trachomatis (CHLa)Test Kit
Chlamydia trachomatis (CHLa)Test Kit Instructions For Use Format: Cassette Specimen: Urethral/Genital Swab Catalog Number: VEL-001-CHLa * Please read the instructions carefully before use INTENDED USE
More informationWHO Prequalification of In Vitro Diagnostics PUBLIC REPORT. Product: OraQuick HIV 1/2 Rapid Antibody Test WHO reference number: PQDx
WHO Prequalification of In Vitro Diagnostics PUBLIC REPORT Product: OraQuick HIV 1/2 Rapid Antibody Test WHO reference number: PQDx 0159-055-00 OraQuick HIV 1/2 Rapid Antibody Test with product codes 5x4-0010
More informationCDIA 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 informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: ABON HIV 1/2/O Tri-Line Human Immunodeficiency Virus Rapid Test Device Number: PQDx 0141-051-00 Abstract ABON HIV 1/2/O Tri-Line Human
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 informationFOR INFORMATIONAL USE ONLY
CLIA-WAIVED PROCEDURE FOR WHOLE BLOOD INTENDED USE QuickVue+ Infectious Mononucleosis test is a rapid Color lmmunochromatographic Assay (CICA) for the detection of Infectious Mononucleosis lgm heterophile
More informationWorksheet. Worksheet. Worksheet. Worksheet. Student Performance Guide. Student Performance Guide
LESSON 6-3 Laboratory Reagent Preparation and Calculations Worksheet LESSON 6-4 Chemistry Instrumentation in the Physician Office Laboratory Worksheet LESSON 6-6 Measuring Blood Glucose Worksheet LESSON
More informationTESTS, REF TESTS)
ENGLISH Read the Package Insert completely before using the product. Follow the instructions carefully when performing testing. Failure to do so may result in inaccurate test results. For In Vitro Diagnostic
More informationHIV Testing. Susan Tusher, LMSW Program Coordinator The Kansas AIDS Education and Training Center
HIV Testing Susan Tusher, LMSW Program Coordinator The Kansas AIDS Education and Training Center The Number of Persons in the US Living with HIV Continues to Increase Over 1 Million people are estimated
More informationMalaria Combo Test Kit
CLIAwaived,Inc. Combo Test Kit A rapid test for the qualitative detection of Plasmodium falciparum and/or Plasmodium vivax, Plasmodium orale and Plasmodium malariae antigen in whole blood. For in-vitro
More informationRapid HIV Antibody Testing Update
Rapid HIV Antibody Testing Update Devery Howerton, Ph.D. Division of Laboratory Systems Centers for Disease Control and Prevention CLIAC meeting, February 15, 2007 Purpose: Why Rapid HIV Testing? An example
More informationHelicobacter pylori Antigen Test
Helicobacter pylori Antigen Test Instructions For Use Format: Cassette For: Catalog Number: VEL-001-HP(s) Specimen: Fecal Specimen * Please read the instructions carefully before use INTENDED USE Helicobacter
More informationHAV IgM Rapid Test(Cassette)
HAV IgM Rapid Test(Cassette) Cat. No.:DTS586 Pkg.Size:25 T Intended use The HAV IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgM antibody to Hepatitis A
More informationOraQuick ADVANCE Rapid HIV-1/2 Antibody Test Customer Letter
OraQuick ADVANCE Rapid HIV-1/2 Antibody Test Customer Letter Dear Customer, Thank you for deciding to use the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test. The sale, distribution, and use of this product
More informationINSTANT-VIEW H. pylori Rapid Test CLIA WAIVED Test for Whole Blood QUALITATIVE IN-VITRO DIAGNOSTIC TEST FOR EXTERNAL USE ONLY
INTENDED USE INSTANT-VIEW H. pylori Rapid Test CLIA WAIVED Test for Whole Blood QUALITATIVE IN-VITRO DIAGNOSTIC TEST FOR EXTERNAL USE ONLY INSTANT-VIEW H. pylori Rapid Test is a rapid qualitative immunoassay
More informationWHO Prequalification of In Vitro Diagnostics PUBLIC REPORT. Product: DPP HIV 1/2 Assay WHO reference number: PQDx
WHO Prequalification of In Vitro Diagnostics PUBLIC REPORT Product: DPP HIV 1/2 Assay WHO reference number: PQDx 0053-006-00 DPP HIV 1/2 Assay with product code 65-9506-0, manufactured by Chembio Diagnostic
More informationCrAg Lateral Flow Assay Standard Operating Procedure
CrAg Lateral Flow Assay Standard Operating Procedure 1.0. Purpose The purpose of this standard operating procedure (SOP) is to detail the steps for correctly performing, interpreting, and documenting valid
More informationPROCEDURE. TITLE: Bedside Glucose Monitoring PC Laboratory. Issuing Department: Clinical Director Signature: Departments Involved:
PROCEDURE TITLE: Bedside Glucose Monitoring Issuing Department: Clinical Director Signature: Departments Involved: Laboratory Nursing Effective Date: 10/97 Review Dates: 09/01, 07/02, 05/13 Revision Dates:
More informationHuman 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 informationPreventID TSH. Additional information Manual Medical information
Additional information Manual Medical information Manual (for professional use) PreventID TSH (KST72116) The PreventID TSH is a rapid test for the determination of TSH in capillary blood, serum or whole
More informationQUICK REFERENCE INSTRUCTIONS For use with Sofia and Sofia 2. Rx only
QUICK REFERENCE INSTRUCTIONS For use with Sofia and Sofia 2. Rx only Test Procedure Study the Package Insert and User Manual thoroughly before using Quick Reference Instructions. This is not a complete
More informationMalaria (Pan-LDH) W/B
CORTEZ DIAGNOSTICS, INC. 23961 Craftsman Road, Suite D/E/F, Calabasas, CA 91302 USA Tel: (818) 591-3030 Fax: (818) 591-8383 E-mail: onestep@rapidtest.com Web site: www.rapidtest.com See external label
More informationPROCEDURE MANUAL. Procedure: CLIA Complexity: Waived for Whole Blood, Moderate for Serum, Plasma. Prepared By Date Adopted Supersedes Procedure #
Procedure #: Procedure: CLIA Complexity: Waived for Whole Blood, Moderate for Serum, Plasma Prepared By Date Adopted Supersedes Procedure # Review Date Revision Date Signature Distributed to # of Copies
More informationBLOOD COLLECTION GUIDELINES
I. Patient Identification Lee Memorial Health System Lee County, FL CLINICAL LABORATORY BLOOD COLLECTION GUIDELINES A. Inpatient / Outpatient with armband 1. When possible, ask patient to state their name
More informationUSO PROFESSIONALE PROFESSIONAL USE
Gima S.p.A. - Via Marconi, 1-20060 Gessate (MI) Italy Italia: tel. 199 400 401 - fax 199 400 403 Export: tel. +39 02 953854209/221/225 fax +39 02 95380056 gima@gimaitaly.com - export@gimaitaly.com www.gimaitaly.com
More informationRapid-VIDITEST. Rota-Adeno Blister. One Step Rotavirus and Adenovirus Antigen Blister test. Instruction manual
Rapid-VIDITEST Rota-Adeno Blister One Step Rotavirus and Adenovirus Antigen Blister test. Instruction manual INTENDED USE: The Rapid-VIDITEST Rota-Adeno Blister test is a rapid chromatographic immunoassay
More informationPROCEDURE. Sekisui Diagnostics OSOM ifob Rapid Test. Title: Procedure #: Institution: Prepared by: Date: Title: Accepted by: Date adopted: Title:
SAMPLE PROCEDURE This Sample Procedure is not intended as a substitute for your facility s Procedure Manual or reagent labeling, but rather as a model for your use in customizing for your laboratory s
More informationNEGATIVE POSITIVE. Rev , 06/11. 5 min. Mono Test. For fi ngertip. blood: 1 DROP 1 DROP For serum, whole blood. plasma or. samples.
Mono Test 1 2 1 DROP 1 DROP For serum, plasma or whole blood samples in tubes: For fi ngertip blood: 3 4 5 min POSITIVE NEGATIVE Rev. 3078-0, 06/11 Mono Test CLIA Complexity: Waived for Whole Blood Non-Waived
More informationRapid-VIDITEST FOB Blister
Rapid-VIDITEST FOB Blister One Step Fecal Occult Blood Blister test. Instruction manual Producer: VIDIA spol. s r.o., Nad Safinou II 365, Vestec, 252 42 Jesenice, Czech Republic, Tel.: +420 261 090 565,
More informationPrecision Xtra Training
Precision Xtra Training Objectives At the end of this module, the participant will be able to: List the steps to calibrate the machine Describe the steps for sample collection and blood glucose testing
More informationFinTest 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 informationProcine sphingomyelin ELISA Kit
Procine sphingomyelin ELISA Kit For the quantitative in vitro determination of Procine sphingomyelin concentrations in serum - plasma - celiac fluid - tissue homogenate - body fluid FOR LABORATORY RESEARCH
More informationNEPHROCHECK 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 informationGeenius TM HIV 1/2 Supplemental Assay Instructions For Use
Geenius TM HIV 1/2 Supplemental Assay Instructions For Use 20 72461 16003787 (Instructions for Use) This IFU is effective beginning with Geenius TM Reader APF (Assay Protocol File) V1.3. Bio-Rad 3, boulevard
More informationThis is a CLIA-waived system. Policies and Procedures Manual
This is a CLIA-waived system. Policies and Procedures Manual Approval date Approved by Reviewed/Revised: Date By whom Title Roche Diagnostics 9115 Hague Road Indianapolis, IN 46256 www.poc.roche.com COAGUCHEK
More informationFor Detection of TSH in Whole Blood: For Professional Use. Whole Blood One-Step Rapid TSH Assay for Hypothyroidism Screening in Adults
For Detection of TSH in Whole Blood: For Professional Use Whole Blood One-Step Rapid TSH Assay for Hypothyroidism Screening in Adults The ThyroTest one-step, rapid TSH assay for hypothyroidism screening
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 informationMTN 009 Laboratory Logistics
MEDICAL RESEARCH COUNCIL OF SA HIV PREVENTION RESEARCH UNIT MTN 009 Laboratory Logistics RASHIKA MAHARAJ HPRU LABORATORY MANAGER Testing Menu Finger stick Blood Samples HIV Rapid Tests* Venous Blood Samples
More informationRapid-VIDITEST. Influenza A+B
Rapid-VIDITEST Influenza A+B (One step Influenza A+B blister Test for the detection of Influenza type A and type B from nasal swabs, nasal wash or nasal aspirate specimens). Instruction manual Producer:
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT. Product: INSTI HIV-1/HIV-2 Antibody Test Number: PQDx
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: INSTI HIV-1/HIV-2 Antibody Test Number: PQDx 0002-002-00 Abstract INSTI HIV-1/HIV-2 Antibody Test with product codes, 90-1013, 90-1010,
More informationHuman Influenza A (Swine Flu) Rapid test
Human Influenza A (Swine Flu) Rapid test Cat.No: DTSXY-Z9 Lot. No. (See product label) Size 20T Intended use The Influenza A (Swine Flu) test is a rapid chromatographic immunoassay for the qualitative
More informationHIV-1 p24 ELISA Kit. Catalog Number KA assays Version: 06. Intended for research use only.
HIV-1 p24 ELISA Kit Catalog Number KA0452 96 assays Version: 06 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Principle of the Assay... 3 General Information... 4 Materials
More informationCHEMSTRIP 10 Urine Test Strips * READ POLICY PRIOR TO STARTING TUTORIAL
CHEMSTRIP 10 Urine Test Strips * READ POLICY PRIOR TO STARTING TUTORIAL Before Testing a Patient Orient yourself to your working area: Locate the test strips. Locate testing supplies: Specimen cup Absorbent
More informationTB LAM Ag Lateral Flow Assay Standard Operating Procedure
TB LAM Ag Lateral Flow Assay Standard Operating Procedure 1.0. Purpose The purpose of this standard operating procedure (SOP) is to detail the steps for correctly performing, interpreting, and documenting
More informationRapid-VIDITEST. Helicobacter pylori. One step Helicobacter pylori Blister test. Instruction manual
Rapid-VIDITEST Helicobacter pylori One step Helicobacter pylori Blister test. Instruction manual Producer: VIDIA spol. s r.o., Nad Safinou II 365, 252 50 Vestec, Czech Republic, Tel.: +420 261 090 565,
More informationHIV Testing Technology and the Latest Algorithm
HIV Testing Technology and the Latest Algorithm David Warshauer, PhD, D(ABMM) Deputy Director, Communicable Diseases Wisconsin State Laboratory of Hygiene HIV Testing has changed over time Patients with
More informationHuman 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 informationMono Test 1 DROP 1 DROP. For fingertip blood: For serum, plasma or whole blood samples in tubes: Rev , 05/09
1 DROP 1 DROP For serum, plasma or whole blood samples in tubes: For fingertip blood: Rev. 38102, 05/09 FOR LABORATORY AND PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY. INTENDED USE The SureVue Signature
More informationCLIA Complexity for Whole Blood: WAIVED. Intended Use. Summary and Explanation
CLIA Complexity for Whole Blood: WAIVED Intended Use The is a lateral-flow immunoassay intended for the rapid, qualitative detection of IgG antibodies specific to Helicobacter pylori in whole blood. The
More informationMARSHALLTOWN MEDICAL & SURGICAL CENTER Marshalltown, Iowa
MARSHALLTOWN MEDICAL & SURGICAL CENTER Marshalltown, Iowa CARE OF PATIENT POLICY & PROCEDURE Policy Number: 4:10 Subject: Policy: Glucose Monitoring (Accuchek) Nursing department staff and laboratory staff
More information8. Quality Assurance Guidelines (Includes Appendices A-G)
8. Quality Assurance Guidelines (Includes Appendices A-G) Quality Assurance Guidelines for Testing Using the OraQuick HCV Rapid Antibody Test This document has been modified by OraSure Technologies from
More informationManagement of Central Venous Access Devices. Blood Glucose Monitoring
Management of Central Venous Access Devices Blood Glucose Monitoring Purpose To provide education on the standard of care regarding the use and monitoring of the Accu- Chek Blood glucose machine, including
More informationCatalog # 0W009 0W010 Test Cassettes, murine monoclonal antibody to human IgG (Test Line) and rabbit polyclonal antibody (Control Line)
For in vitro diagnostic use. CLIA Complexity for Whole Blood: WAIVED INTENDED USE The QuickVue H. pylori Test is a lateral-flow immunoassay intended for the rapid, qualitative detection of IgG antibodies
More informationRapid-VIDITEST C. difficile Ag (GDH) Card/Blister
Li StarFish S.r.l. Via Cavour, 35-20063 Cernusco S/N (MI), Italy Tel. +39-02-92150794 - Fax. +39-02-92157285 info@listarfish.it -www.listarfish.it Rapid-VIDITEST C. difficile Ag (GDH) Card/Blister One
More informationThyroid 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 informationHIV-1 p24 ELISA Kit. Cat.No: DEIA10155 Lot. No. (See product label) Size. Storage. Principle Of The Test. Reagents And Materials Provided
HIV-1 p24 ELISA Kit Cat.No: DEIA10155 Lot. No. (See product label) Size 96T Storage All reagents should be stored at 2-8 C, and should not be used beyond the expiration date on the label. Once opened,
More informationQUICK REFERENCE INSTRUCTIONS
QUICK REFERENCE INSTRUCTIONS For use with the Sofia Analyzer only. CLIA Complexity: WAIVED Nasal Swab and Nasopharyngeal Swab specimens ONLY. Study the Package Insert and User Manual thoroughly before
More informationAbbott PXP Glucose Meters Resource: Lin Gustafson, MT(ASCP) Point of Care Coordinator, Laboratory
Abbott PXP Glucose Meters 2015 Resource: Lin Gustafson, MT(ASCP) Point of Care Coordinator, Laboratory Objectives After you complete this Computer-Based Learning (CBL) module, you should be able to: Explain
More informationCatalog # 0W009 0W010 Test Cassettes, murine monoclonal antibody to human IgG (Test Line) and rabbit polyclonal antibody (Control Line) Reagents
For in vitro diagnostic use. CLIA Complexity: MODERATE INTENDED USE The QuickVue H. pylori Test is a lateral-flow immunoassay intended for the rapid, qualitative detection of IgG antibodies specific to
More informationToxoplasma 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 informationQUICK REFERENCE INSTRUCTIONS For use with Sofia only.
QUICK REFERENCE INSTRUCTIONS For use with Sofia only. CLIA Complexity: Waived Study the Package Insert and User Manual thoroughly before using Quick Reference Instructions. This is not a complete Package
More informationMouse/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 informationCarnitine / Acylcarnitines Dried Blood Spots LC-MS/MS Analysis Kit User Manual
Page 1 / 14 Carnitine / Acylcarnitines Dried Blood Spots LC-MS/MS Analysis Kit User Manual ZV-3051-0200-15 200 Page 2 / 14 Table of Contents 1. INTENDED USE... 3 2. SUMMARY AND EXPLANATION... 3 3. TEST
More informationHIV and Syphilis Testing in Non-Clinical Settings, Jamaica
HIV and Syphilis Testing in Non-Clinical Settings, Jamaica National Public Health Laboratory/National HIV/STI Programme, Ministry of Health, Jamaica January 2014 Preface The adult HIV prevalence in Jamaica
More informationAdvantages and disadvantages of different types of FDA-approved HIV immunoassays used for screening by generation and platform*
Advantages and disadvantages of different types of FDA-approved HIV immunoassays used for screening by generation and platform* HIV immunoassays grouped by generation, platform, and CLIA complexity + Advantages
More informationNCCLS. Accutest H. pylori WB Test. (Catalog. No. ID-92A225) For Professional and In Vitro Diagnostic Use Only
NCCLS Accutest H. pylori WB Test (Catalog. No. ID-92A225) For Professional and In Vitro Diagnostic Use Only A Rapid Visual Test for the Qualitative Detection of IgG Antibodies Specific to Helicobacter
More informationRapid-VIDITEST. Strep A Blister. One step Strep A Blister for the detection of Group A Streptococcal antigen from throat swabs or culture.
Rapid-VIDITEST Strep A Blister One step Strep A Blister for the detection of Group A Streptococcal antigen from throat swabs or culture. Instruction manual Producer: VIDIA spol. s r.o., Nad Safinou II
More informationCoaguChek XS Plus System Whole Blood Protime/INR
1 CoaguChek XS Plus System Whole Blood Protime/INR A. PURPOSE The CoaguChek XS System is intended for use by professional healthcare providers for quantitative protime testing (PT) and calculated INR for
More informationSpecimen Collection Policies
Specimen Collection Policies Purpose Great River Medical Center Laboratory is a hospital-based and outreach laboratory with specific standards of excellence. To best serve our patients, all specimens will
More informationToxoplasma 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 informationHuman 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 informationInfectious Mononucleosis IM Cassette Test RAPU04A830
Infectious Mononucleosis IM Cassette Test RAPU04A830 DIAsource ImmunoAssays S.A. - Rue de l'industrie, 8 - B-1400 Nivelles - Belgium : 090714/1 en DIAsource IM (Mononucleosis) Test Cassette for whole blood,
More informationStrep-a-Test Twister Test
Strep-a-Test Twister Test Code: 24524 A rapid test for the qualitative detection of Strep A antigen in throat swab specimens. For professional in vitro diagnostic use only. INTENDED USE The Strep A Twist
More informationHBeAg 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 informationINTEGRATING HIV SCREENING INTO ROUTINE PRIMARY CARE: A HEALTH CENTER MODEL
INTEGRATING HIV SCREENING INTO ROUTINE PRIMARY CARE: A HEALTH CENTER MODEL By Cheryl Modica, PhD, MPH, BSN NACHC Consultant The health center model has helped reduce health disparities among many poor
More informationA Summary of Clinical Evidence
A Summary of Clinical Evidence Supporting the use of the Alere Determine HIV-1/2 Ag/Ab Combo Rapid Test to assist in the diagnosis of Human Immunodeficiency Virus (HIV) TAP HERE TO SEE THE PRODUCTS Table
More informationCYTOMEGALOVIRUS (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 informationPoint-of-care HIV testing
Point-of-care HIV testing Joanne Stekler, MD MPH Associate Professor University of Washington December 5, 2016 Disclaimer: The findings and conclusions in this presentation are those of the author(s) and
More informationIVD Revised 22 July, 2008
INTENDED USE The DRG One Step HCG Pregnancy Test is an in vitro diagnostic test for the qualitative detection of human chorionic gonadotropin (hcg) in urine. The test is a two-site immunoassay employing
More informationAccu-Chek Inform II: Point of Care Glucose Testing. Sharp Healthcare 2014
Accu-Chek Inform II: Point of Care Glucose Testing Sharp Healthcare 2014 OBJECTIVES At the completion of this module the participant will be able to: Learn the proper technique of performing a finger stick
More informationOpiates Rapid Test. Cat. No.:DTS137 Pkg.Size:50T. Intended use. General Description. Principle Of The Test. Reagents And Materials Provided
Opiates Rapid Test Cat. No.:DTS137 Pkg.Size:50T Intended use The CD One Step Opiates Screening Test is a rapid, qualitative immunoassay for the detection of opiates and opiate metabolites in urine. The
More information