New HIV Tests and Algorithm: A change we can believe in
|
|
- Arline Shelton
- 6 years ago
- Views:
Transcription
1 New HIV Tests and Algorithm: A change we can believe in Esther Babady, PhD, D (ABMM) Memorial Sloan-Kettering Cancer Center New York, New York
2 Learning Objectives After this presentation you should be able to: List new methods used for diagnosis of HIV infections Explain the advantages of new methods in diagnosis of HIV infections Describe the most recent CDC/APHL laboratory testing recommendations for HIV diagnosis
3 Case 68 yo woman Developed a large parotid mass on neck Radiologic studies: Abnormal Fine needle aspirate of parotid Enlarged, atypical cells and abundant necrosis Suggestive of B cell lymphoma
4 Case Non-Hodgkin s Lymphoma confirmed Pre-chemotherapy Infectious Diseases Evaluation Hepatitis serologies HIV serologies
5 Case Tests Results Reference range Hepatitis B surface antigen Negative Negative Hepatitis B surface antigen Positive Positive* antibody Hepatitis B core antibody (Total) Positive Negative Hepatitis B core antibody IgM Negative Negative Hepatitis B quantitative PCR Negative [20-170,000,000 IU/mL] Hepatitis C antibody Negative Negative HIV-1 and HIV-2 antibodies Negative Negative
6 Case Patient admitted 1 week later Started on chemotherapy protocol Tests Results Reference range HIV-1 and HIV-2 Negative Negative Tests antibodies Results Reference range HIV-1 quantitative PCR 120,000 [20-10,000,000 copies/ml]
7 Memorial Sloan-Kettering Cancer Center
8 Background: The virus Enveloped positive-sense ss RNA virus Retroviridae Lentivirus ~100 nm diameter 9.7 kb genome 5 and 3 LTR, 9-10 genes
9 Background: HIV Phylogeny Groups Major (M) Subtypes A, B, C, D, E,F, G, H, J, K HIV-1 Non M/O (N) Outlier (O) Pending (P) Circulating recombinant forms A HIV-2 B C,D,E,F,G,H
10 Background: HIV Distribution Subtypes Subtype A Subtype B Subtype C Subtype D Subtype F Subtype G Subtype H Subtype J Subtype K HIV-2 Geography West Africa North America and Europe South Africa and S/E Asia Eastern and central Africa Central Africa, South America and Eastern Europe Africa and Central Europe Central Africa Africa and Caribbean DRC and Cameroon West Africa McCutchan, F.E. JMV 2006
11 Background: Stages of Infection Acute Flu-like symptoms Highly infectious Weeks Established Mild or No symptoms Infectious Years AIDS Low CD4 count Opportunistic infections Years Naif, H.M. Infect Dis Rep. 2013
12 Background: Epidemiology Memorial Sloan-Kettering Cancer Center
13 Background: Epidemiology Memorial Sloan-Kettering Cancer Center
14 Trends in Annual Age-Adjusted* Rate of Death Due to HIV Infection, United States, Memorial Sloan-Kettering Cancer Center Note: For comparison with data for 1999 and later years, data for were modified to account for ICD-10 rules instead of ICD-9 rules. *Standard: age distribution of 2000 US population
15 Stage 3 (AIDS) Classifications and Deaths of Persons with HIV Infection Ever Classified as Stage 3 (AIDS), among Adults and Adolescents, United States and 6 Dependent Areas Note. All displayed data have been statistically adjusted to account for reporting delays, but not for incomplete reporting. Deaths of persons with HIV infection, stage 3 (AIDS) may be due to any cause.
16 Need for new recommendations?
17 Need for new recommendations? Better tests Simpler tests More commercially available tests More treatment options
18 Laboratory testing sequence CDC and APHL. Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations. June 27, Accessed [04/2015]
19 CDC and APHL. Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations. June 27, Accessed [04/2015]
20 Laboratory testing: Immunoassays Utility: Screening Diagnostics Additional testing: Acute vs Established 5 LTR gag pol vif/vpr/tat rev/vpu env tat nef 3 LTR
21 Laboratory Testing: Immunoassays 1 st generation HIV-1 IgG ab Viral culture cell lysates 2 nd generation HIV-1/2 IgG ab Viral culture cell lysates Synthetic/Recombinant ag 3 rd generation HIV-1/2 IgM/IgG ab Synthetic/Recombinant ag 4 th generation HIV-1/2 IgM/IgG ab p24 ag Synthetic/Recombinant ag CDC and APHL. Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations. June 27, Accessed [04/2015]
22 Laboratory Testing: Western blot Cambridge Biotech HIV-1 Western Blot Kit PI
23 Laboratory Testing: Rapid HIV tests Manufacturer Rapid test: Test CLIA waived Methods Target Date Alere Scarborough Bio-Rad Laboratories, Inc Alere Determine HIV- 1/2 Ag/Ab Combo Geenius HIV 1/2 Supplemental Assay Lateral flow Immunoassay Immunochromatograph HIV-1 HIV-2 p24 HIV-1 HIV Accessed 4/2015
24 Laboratory Testing: Rapid HIV tests Manufacturer Test Methods Target Date Bio-Rad Laboratories, Inc. OraSure Technologies Multispot HIV- 1/HIV-2 Rapid Test OraQuick ADVANCE Rapid HIV-1/2 Antibody Immunoconcentration Microparticle Lateral flow Immunoassay HIV-1 HIV-2 HIV-1 HIV Accessed 4/2015
25 Laboratory Testing: Immunoassays Manufacturer Test Methods Generation Date cleared Abbott Diagnostics Bio-Rad Laboratories, Inc. Ortho Clinical Diagnostics Siemens Healthcare diagnostics Architect HIV Ag/Ab combo GS HIV Combo Ag/Ab Vitros Anti-HIV 1+2 Advia Centaur HIV 1/0/2 Chemiluminescence Microparticle Immunoassay Enzyme Immunoassay Chemiluminescence Immunoassay Chemiluminescence Immunoassay 4 th th rd rd 2006 Accessed 4/2015
26 Laboratory Testing: Molecular tests Utility Diagnosis of HIV infection (Qualitative) Baseline viral load before initiation of treatment (Quantitative) Monitoring of response to antiviral treatment (Quantitative) 5 LTR gag pol vif/vpr/tat rev/vpu env tat nef 3 LTR
27 Laboratory Testing: Molecular tests Examples of Qualitative Molecular Methods Manufacturer Test Methods LOD Hologic Aptima HIV-1 RNA TMA 100 qualitative assay HPA copies/ml Accessed 4/2015
28 Laboratory Testing: Molecular tests Manufacturer Test Methods Linear range Abbott Molecular Realtime HIV-1 RT-PCR 40-10,000,000 copies/ml Roche Molecular Siemens Cobas Ampliprep/Cobas Taqman quantitative HIV-1 v.2.0 COBAS TaqMan HIV Test v2.0 For Use With The High Pure System Cobas Amplicor HIV Monitor v1.5 VERSANT HIV 3.0 Assay (bdna) RT-PCR RT-PCR RT-PCR bdna signal amplification 20-10,000,000 copies/ml 34-10,000,000 copies/ml 50-75,000 copies/ml ,000 copies/ml ,000 copies/ml Accessed 4/2015
29 Laboratory Testing: Molecular Tests Highly specific and excellent sensitivity Expected viral loads log IU/mL Measured viral loads log IU/mL ULOQ LLOQ LOD
30 Laboratory Testing: Studies Comparison of WB to a rapid antigen test to on specimens reactive by a 4 th generation IA Philadelphia, PA Accuracy Rapid antigen test vs WB: 98.2% vs. 57.9% Specificity Rapid antigen test vs WB: HIV-2 misidentified as HIV-1 by WB. Cardenas, A.M. et al., Journal of Clinical Virology 58S1 (2013), e97 e103
31 Laboratory Testing: Studies Comparison of a rapid antigen test to WB, 3 rd and 4 th generation immunoassays. Commercial panels (HIV-1 and HIV-2) Seroconversion Rapid antigen test: 7-15 days earlier than WB. Accuracy Rapid antigen test was reactive in 99.0% and 92.5% of 3rd and 4th generation Masciotra, S. et al., Journal of Clinical Virology 58S (2013) e54 e58
32 Laboratory Testing: Studies 4 th generation HIV Ab/Ag, WB and HIV-1 RNA HIV treatment center: Amsterdam, Netherlands ~5,000/years over 10 years: 75 cases Ab/Ag positive, WB negative, HIV-1 RNA not detected 7 cases Ab/Ag positive, WB negative, HIV-1 RNA detected 6 cases Ab/Ag negative, WB negative, HIV-1 RNA detected Sensitivity/specificity: 99.6%/99.8%. Jurriaans, S. et al., Journal of Clinical Virology 52S (2011), S67-S69
33 Laboratory Testing: Studies Comparison of 3 rd and 4 th generation IA Multi sites study: CA and WA Seroconversion 4 th generation vs 3 rd generation: 7-11 days earlier Specificity 4 th generation vs 3 rd generation: % Mitchell, E.O. et al., Journal of Clinical Virology 58S1 (2013), e79-e84
34 Laboratory Testing: Studies Comparison of WB to RAT and NAAT. 11 U.S. public health laboratories 570 remnant 3 rd gen IA reactive, HIV WB neg or indeterminate. ~90% confirmed HIV negative ~10% HIV positive (~3% acute HIV and 0.2% HIV-2). Linley, L. et al., Journal of Clinical Virology 58S1 (2013), e108-e112
35 Laboratory testing: Genotyping Utility: Monitoring HIV-1 resistance Baseline before start of antiretroviral therapy (ART) Guide alternative ART selection in cases of drug therapy failure
36 Laboratory Testing: Genotyping Examples of Genotyping assays Manufacturer Test Methods LOD Target Abbott Molecular Siemens Molecular Diagnostics Viro Seq HIV-1 sequencing system TRUGENE HIV -1 Genotyping Assay Sequencing 2000 copies /ml Protease RT Sequencing 1000 copies/ml
37 U.S. Preventive Services Task Force
38 CDC HIV Testing Guidelines 1989: Testing for HIV-1 immunoassays and confirmation with HIV-1 WB or IFA (MMWR v38, 1989) 1992: Testing for HIV-2 antibodies (MMWR v41, 1992) 2004: Use of HIV-1 WB/IFA to confirm reactive rapid test results (MMWR v53, 2004)
39 CDC HIV Screening Guidelines 2014: Recommended algorithm Initial testing for HIV should be done using 4 th generation immunoassay Reactive screen should be confirmed with an Ab test that differentiates HIV-1 and HIV-2 If reactive samples do not confirm, additional testing with a HIV-1 NAT Algorithm should be applied to reactive rapid tests CDC and APHL. Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations. June 27, Accessed [04/2015]
40 CDC HIV Screening Guidelines 2014: Alternative algorithms Reactive 3 rd generation immunoassay followed by recommended algorithm Reactive WB/IFA followed by HIV-1 NAT and HIV-2 ab test if necessary Reactive 4 th generation IA followed by HIV-1 NAT Nonreactive 3 rd and 4 th generation IA followed by HIV-1 NAT CDC and APHL. Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations. June 27, Accessed [04/2015]
41 New Testing algorithm CDC and APHL. Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations. June 27, Accessed [04/2015]
42 Reporting results CDC guidelines, 2014
43 Conclusions Several, new, sensitive and user-friendly assays are now available for accurate diagnosis of HIV Recent CDC/APHL recommendations use combinations of these new methods to identify more cases of acute HIV infections
44 Self-Assessment Questions 1. The new CDC/APHL recommends that a reactive 4 th generation immunoassay be followed by testing with which of the following tests? A. HIV-1/HIV-2 ab C. Western Blot B. HIV-1 RNA D. HIV-2 RNA 2. Which of the following HIV antigens is detected by antibody/antigen combo assays? A. p24 C. gp120 B. p55 D. gp160
45 Self-Assessment Questions 3. Use of the new CDC/APHL HIV testing algorithm improves detection of acute HIV? A. True B. False 4. Which of the following test is reactive during the eclipse period of HIV infection? A. qualitative HIV-1 RNA C. Both of the above B. 4 th generation IA D. None of the above
Learning Objectives. New HIV Testing Algorithm from CDC. Overview of HIV infection and disease 3/15/2016
New HIV Testing Algorithm from CDC ASCLS-Michigan March 31, 2016 Dr. Kathleen Hoag Learning Objectives Following attendance and review of material provided, attendees will be able to: 1. Describe the new
More informationHIV Update in Laboratory Testing. Patricia Slev, PhD, D(ABCC)
HIV Update in Laboratory Testing Patricia Slev, PhD, D(ABCC) Objectives Explain the advances in HIV diagnostics, including fourth generation Ag/Ab combination HIV screening assays Describe the new CDC
More informationDiagnostic Tests for HIV
Mountain West AIDS Education and Training Center Diagnostic Tests for HIV David Spach, MD Principal Investigator, Mountain West AETC Professor of Medicine, University of Washington Last Updated: June 22,
More informationHIV Test Technologies, Best Practices, and New Algorithm. Jenny R. McFarlane DSHS HIV Prevention and Care Branch
HIV Test Technologies, Best Practices, and New Algorithm Jenny R. McFarlane DSHS HIV Prevention and Care Branch Testing History 1985 1 st Gen HIV-1 IA 1987 HIV-1 WB 1990 HIV-2 IA HIV-1 IA DBS 1991 2 nd
More information2018 HIV and HCV Diagnostic Testing Survey
2018 HIV and HCV Diagnostic Testing Survey This survey is designed to capture the 2017 HIV and HCV testing practices in state and local public health laboratories (PHL). The results of the survey will
More informationThe Latest in HIV Tests: What Do the Results Mean?
The Latest in HIV Tests: What Do the Results Mean? Bernard M. Branson MD Principal Consultant, Scientific Affairs LLC Atlanta, Georgia Objectives At the end of this workshop, participants will be able
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 information1 st and 2 nd Generation EIA
HIV Diagnostic Tests Bernard M. Branson, M.D. Associate D irector for Laboratory D iagnostics Division of HIV/AIDS Prevention Centers for D isease Control & Prevention The views expressed in this presentation
More informationList the steps in the fourth generation HIV screening algorithm Describe the relationship between rapid HIV antibody tests and the fourth generation
Alere (honoraria) List the steps in the fourth generation HIV screening algorithm Describe the relationship between rapid HIV antibody tests and the fourth generation testing algorithm Interpret challenging
More informationOverview of HIV Testing Practices and Technology
Overview of HIV Testing Practices and Technology 2019 HIV Diagnostics Conference March 25 th, 2019 Michele Owen, Ph.D National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention Centers for Disease
More informationComplicated viral infections
Complicated viral infections Clinical case discussion Diagnostic dilemmas NSW State Reference Laboratory for HIV St Vincent s Hospital Sydney Diagnostic dilemmas Indeterminate or discordant serology (western
More informationNew Generation of Nucleic Acid Testing. Michele Owen, Ph.D Division of HIV/AIDS Prevention Centers for Disease Control & Prevention
New Generation of Nucleic Acid Testing Michele Owen, Ph.D Division of HIV/AIDS Prevention Centers for Disease Control & Prevention Percentage (%) Persons Living with Diagnosed or Undiagnosed HIV Infection
More informationEvolution of HIV Diagnostics. Goals for the 2010 Conference. Bernard M. Branson, M.D. CDC Division of HIV/AIDS Prevention
Evolution of HIV Diagnostics and Goals for the 2010 Conference Bernard M. Branson, M.D. Associate Director for Laboratory Diagnostics CDC Division of HIV/AIDS Prevention Evolution or other influences like
More informationARCHITECT HIV Ag/Ab Combo: Moving HIV Diagnostics Forward in the U.S.
ARCHITECT HIV Ag/Ab Combo: Moving HIV Diagnostics Forward in the U.S. Catherine Brennan, Ph.D. Research Fellow Infectious Diseases Research Abbott Diagnostics 1 Agenda ARCHITECT HIV Ag/Ab Combo Assay What
More informationMicropathology Ltd. University of Warwick Science Park, Venture Centre, Sir William Lyons Road, Coventry CV4 7EZ
www.micropathology.com info@micropathology.com Micropathology Ltd Tel 24hrs: +44 (0) 24-76 323222 Fax / Ans: +44 (0) 24-76 - 323333 University of Warwick Science Park, Venture Centre, Sir William Lyons
More informationRoutine HIV Testing Community of Practice Session #2
Routine HIV Testing Community of Practice Session #2 Presenters: Denver Prevention Training Center Broward Community & Family Health Centers, Inc. 20 March 2016 Communities of Practice Routine HIV Testing
More informationUsing all the data: Immunoassay signal-to-cutoff values provide useful information that should be considered in HIV diagnostic
Using all the data: Immunoassay signal-to-cutoff values provide useful information that should be considered in HIV diagnostic algorithms KP Delaney, M Pentella, B Bennett, and K Landgraf for the CDC/APHL
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 informationAdventures in Discordance- HIV Testing
Anne Gaynor, PhD On behalf of Monica M. Parker, PhD Director, Bloodborne Viruses Laboratory Wadsworth Center, NYSDOH Adventures in Discordance- HIV Testing HIV Laboratory Testing Algorithm HIV-1/2 antigen/antibody
More informationHEALTH. Re: Interim Guidelines for Laboratories on the use of a new Diagnostic Testing Algorithm for Human Immunodeficiency Virus (HIV) Infection
===========ir ~~!!~~fk li=:='========= Nirav R. Shah, M.D., M.P.H. Commissioner May 16, 2013 HEALTH Sue Kelly Executive Deputy Commissioner Re: Interim Guidelines for Laboratories on the use of a new Diagnostic
More informationThe Evolving Landscape of HIV Prevention and Diagnosis
The Evolving Landscape of HIV Prevention and Diagnosis Jenny R. McFarlane Texas Department of State Health Services HIV/STD/TB/Viral Hepatitis Unit Is it okay if we just talk? NHAS: A Call to ACT Reduce
More informationSupplementary Online Content
Supplementary Online Content Peters PJ, Westheimer E, Cohen S, et al. Screening yield of HIV antigen/antibody combination and pooled HIV RNA testing for acute HIV infection in a high-prevalence population.
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 informationHIV Serology Quality Assessment Program Summary for Panel HIVS Oct22
National Laboratory for HIV Reference Services National HIV and Retrovirology Laboratories National Microbiology Laboratory Public Health Agency of Canada HIV Serology Quality Assessment Program Summary
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 information100 Abbott Park Road Abbott Park, IL Trade Name: ARCHITECT HIV Ag/Ab Combo Assay Approved Date: 18-JUN-2010
Currently Approved CBER Device Premarket Applications (PMAs) As of Nov 10, 2014 Sorted by Applicant Name BP090080-0 BP060002-0 BP120037-0 BP090022-0 BP090032-0 BP040046-0 BP100064-0 BP140120-0 Abbott Laboratories
More informationHIV Serology Quality Assessment Program Summary for Panel HIVSER 2017Apr19
National Laboratory for HIV Reference Services National HIV and Retrovirology Laboratories National Microbiology Laboratory Public Health Agency of Canada HIV Serology Quality Assessment Program Summary
More informationINTEGRATING HIV AND HCV TESTING
INTEGRATING AND HCV TESTING OVERVIEW Increasingly health departments (HDs) are seeking new strategies to improve the productivity and yield of testing and linkage programs, expand availability of and access
More informationDiagnosing HIV Infection AMNERIS E. LUQUE, M.D. PROFESSOR OF MEDICINE/INFECTIOUS DISEASES MEDICAL DIRECTOR, PARKLAND HIV SERVICES
Diagnosing HIV Infection AMNERIS E. LUQUE, M.D. PROFESSOR OF MEDICINE/INFECTIOUS DISEASES MEDICAL DIRECTOR, PARKLAND HIV SERVICES Disclosures None Objectives 1. Outline the CDC recommendations for HIV
More informationTechnical Bulletin No. 104b
CPAL Central Pennsylvania Alliance Laboratory Technical Bulletin No. 104b June 22, 2016 Update to Guidelines for Diagnosing HIV Infection CPAL s Testing Algorithm for Diagnostic HIV Testing HIV Geenius
More informationOpportunities Created by Diagnostic HCV and HIV Nucleic Acid Tests
Opportunities Created by Diagnostic HCV and HIV Nucleic Acid Tests Ann Winters, MD Medical Director, Viral Hepatitis Program, Bureau of Communicable Disease, New York City Department of Health and Mental
More informationAn Evaluation of Qualitative HIV-2 RNA Referral Testing
An Evaluation of Qualitative HIV-2 RNA Referral Testing Linda M. Styer, Anne Gaynor, Laura Wesolowski, Steve Ethridge and Monica M. Parker Wadsworth Center, NYSDOH; APHL; Division of HIV/AIDS Prevention,
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 IMMUNODEFICIENCY VIRUS (HIV) NON-IMMEDIATE NOTIFICATION STD PROGRAM. Version
1 HUMAN IMMUNODEFICIENCY VIRUS (HIV) NON-IMMEDIATE NOTIFICATION STD PROGRAM Event Name: Event Time Period: ADULT HIV 900 (AIDS.gov 12/31/2015) HIV Lifelong HIV (human immunodeficiency virus) is a retrovirus
More information2017 HIV AND HCV DIAGNOSTICS SURVEY REPORT
207 HIV AND HCV DIAGNOSTICS SURVEY REPORT MARCH 209 Table of Contents Background...3 Methods...3 Workforce...3 HIV Assay Utilization...4 Turnaround Time...6 Testing Volume and Specimen Types...7 Testing
More informationHIV testing has significantly improved
HIV testing: an update By Nicola Zetola, MD, and Jeffrey D. Klausner, MD, MPH HIV testing has significantly improved since the first diagnostic test in 1985. Increased understanding of HIV transmission
More informationHIV: 2009 DIAGNOSTIC SURVEY FACING NEW CHALLENGES
ISSUES IN BRIEF: MEMBER SURVEY OF HIV ASSAY USE ASSOCIATION OF PUBLIC HEALTH LABORATORIES MARCH 2010 HIV: 2009 DIAGNOSTIC SURVEY FACING NEW CHALLENGES Twenty years ago, the Association of Public Health
More informationAccuVert HIV-1 Seroconversion Panel PRB974 ( )
PACKAGE INSERT PRB974 (0600-0258) INTENDED USE PRB974 (0600-0258) is a group of serial bleeds from an individual plasma donor during seroconversion. This panel is intended for use by diagnostics manufacturers
More informationHIV-1 Seroconversion Panel PRB973
A SERACARE PANEL PRODUCT INTENDED USE The is a group of serial bleeds from an individual plasma donor during seroconversion. This panel is intended for use by diagnostics manufacturers and clinical laboratorians
More informationA Case of False-Positive Test Results in a Pregnant Woman of Unknown HIV Status at Delivery
A Case of False-Positive Test Results in a Pregnant Woman of Unknown HIV Status at Delivery Pascale Akl, MD, 1 Kenneth E. Blick, PhD 1* Lab Med Spring 2014;45:259-263 DOI: 10.1309/LMAAGVXK05LUWOQN ABSTRACT
More informationTEST REQUEST INFORMATION- VIROLOGY
Chlamydia/ Gonorrhea Nucleic Acid Amplification VC75 Qualitative Nucleic Acid Amplification SPECIMEN: Genital swab or first catch urine CONTAINER:GEN-PROBE APTIMA 2 Combo swab transport tube or urine transport
More informationHIV Serology Quality Assessment Program Summary for Panel HIVSER 2018Apr19
National Laboratory for HIV Reference Services National HIV and Retrovirology Laboratories National Microbiology Laboratory Public Health Agency of Canada HIV Serology Quality Assessment Program Summary
More informationHIV-1 Seroconversion Panel PRB975
Seroconversion OVERVIEW is a five member HIV Seroconversion collected from a single donor over a 14 day period in 2002, prior to antibody seroconversion. -03 is a challenging sample for HIV RNA assays,
More informationClinical Education Initiative TESTING FOR HIV AND HCV: WHAT S CURRENT AND WHAT S COMING. Bernard M.
Clinical Education Initiative Support@ceitraining.org TESTING FOR HIV AND HCV: WHAT S CURRENT AND WHAT S COMING Bernard M. Branson, MD 1/23/2018 Testing for HIV and HCV: What s Current and What s Coming
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 informationAccuVert HBV Seroconversion Panel PHM941(M) ( )
PACKAGE INSERT PHM941(M) (0605-0061) INTENDED USE PHM941(M) (0605-0061) is a group of serial bleeds from an individual plasma donor during HBV seroconversion. This panel is intended for use by diagnostics
More informationHigh Rate of Missed HIV Infections in Individuals With Indeterminate or Negative HIV Western Blots Based on Current HIV Testing Algorithm in China
Journal of Medical Virology 88:1462 1466 (2016) High Rate of Missed HIV Infections in Individuals With Indeterminate or Negative HIV Western Blots Based on Current HIV Testing Algorithm in China Man-Qing
More informationHOPE Follow-Up Algorithm: Unusual Cases. Urvi Parikh, PhD MTN Virology Core Regional Meeting Lab Breakout Sept 27-28, 2016, Cape Town
HOPE Follow-Up Algorithm: Unusual Cases Urvi Parikh, PhD MTN Virology Core Regional Meeting Lab Breakout Sept 27-28, 2016, Cape Town MTN-025 Testing Algorithm Screening/Enrollment MTN-025 Testing Algorithm
More informationFrequency of occult hepatitis B in HBsAg seronegative blood donors in a tertiary care hospital in kerala,south India.
Frequency of occult hepatitis B in HBsAg seronegative blood donors in a tertiary care hospital in kerala,south India. Cinzia Keechilot, Veena Shenoy 1,V Anil kumar 2,Lalita Biswas 3. MBBS student * Transfusion
More informationThe Alphabet Soup of Viral Hepatitis Testing
The Alphabet Soup of Viral Hepatitis Testing August 18, 2011 Patricia Slev, PhD, DABCC Medical Director, Serologic Hepatitis and Retrovirus Laboratory, ARUP Laboratories Assistant Professor of Pathology,
More informationHIV-1 Seroconversion Panel
OVERVIEW This Data Sheet contains test results specific for HIV-1. s are undiluted aliquots from plasma units collected from a single donor. No preservatives were added. CAUTION: Potentially infectious
More informationSchedule of Accreditation
Schedule of Accreditation Organisation Name National Virus Reference Laboratory INAB Reg No 326MT Contact Name Eimear Malone Address University College Dublin, Belfield, Dublin Contact Phone No 01-7161319
More informationClinical HIV-2 Viral Load Testing of a Large Population of HIV-2 Infected Individuals
Clinical HIV-2 Viral Load Testing of a Large Population of HIV-2 Infected Individuals Linda M. Styer Wadsworth Center, NYSDOH ** The authors have no conflicts of interest to disclose ** HIV-2 viral load
More informationAPHL/CDC HIV Demonstration Project Demonstration Project for HIV Nucleic Acid Testing (NAT) Referral Updated: January 2018
APHL/CDC HIV Demonstration Project Demonstration Project for HIV Nucleic Acid Testing (NAT) Referral Updated: January 2018 Shipping and Submission Instructions Thank you for participating as a submitting
More informationHIV-1 AccuVert TM Seroconversion Panel
PACKAGE INSERT PRB954 (0600-0238) INTENDED USE The is intended for use by diagnostic manufacturers, researchers, and clinical laboratories to develop, evaluate, or troubleshoot test methods. Characterized
More informationTechnical Bulletin No. 104a
CPAL Central Pennsylvania Alliance Laboratory Technical Bulletin No. 104a April 22, 2014 Update to Guidelines for Diagnosing HIV Infection - CPAL s Testing Algorithm for Diagnostic HIV Testing Contact:
More informationAccuSet HCV Performance Panel
Signal to cutoff (s/co) DATA SHEET OVERVIEW AccuSet HCV (0810-0204) is a 25-member validation panel of undiluted, naturally occurring plasma samples (1 vial per member, 1.0 ml per vial). Panel members
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 informationAccuSet HIV-1/2 Performance Panel
OVERVIEW AccuSet HIV-1/2 (0800-0380) is a 13-member validation panel of undiluted, naturally occurring plasma samples (1 vial per member, 1.0 ml per vial). Panel members represent bleeds from multiple
More informationAdvaMedDx Value Assessment Framework in Practice
AdvaMedDx Value Assessment Framework in Practice Application of the Comprehensive Assessment of the Value of Diagnostic Technologies Framework to Abbott s 4th Generation ARCHITECT HIV Antigen/Antibody
More informationImmunologic Methods in Diagnosis of HIV Infection. Tehran Medical Sciences Branch, Islamic Azad
Immunologic Methods in Diagnosis of HIV Infection M Parsania, Ph.D. Tehran Medical Sciences Branch, Islamic Azad University Retroviridae Retroviruses (family Retroviridae) id ) are enveloped, single stranded
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 informationHIV Serology Quality Assessment Program Revised Summary for Panel HIVSER 2017Oct27
National Laboratory for HIV Reference Services National HIV and Retrovirology Laboratories National Microbiology Laboratory Public Health Agency of Canada HIV Serology Quality Assessment Program Revised
More informationAccuSet Anti-HIV-1 Mixed Titer Performance Panel
signal to cut-off (s/co) DATA SHEET OVERVIEW PRB205(M3) is a modified 16-member panel originating from Anti- HIV-1 Mixed Titer PRB205(M2). Panel members 3, 5, 6, 17, 21, 22, 23, 24, and 25 from the original
More informationSchedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK West of Scotland Specialist Virology Centre New Lister Building Level 5 Glasgow Royal Infirmary 10-16 Alexandra Parade Glasgow G31 2ER Contact:
More informationExpression of HIV-1 Markers During Progression of Infection E E E Days Since 1st Bleed
Seroconversion OVERVIEW HIV-1 AccuVert TM Seroconversion PRB970 is a 4 member, 1.0 ml per vial panel of undiluted, naturally-occurring plasma samples. members represent serial bleeds collected from a single
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 informationResearch Article Decision on conducting HCV Immunoblot and HCV Viral Load Tests Dependent upon the Result of the Screening Tests
IBIMA Publishing Journal of Virology & Microbiology http://www.ibimapublishing.com/journals/jvm/jvm.html Vol. 2013 (2013), Article ID 332501, 7 pages DOI: 10.5171/2013.332501 Research Article Decision
More informationQUANTITATIVE HIV RNA (VIRAL LOAD)
CLINICAL GUIDELINES For use with the UnitedHealthcare Laboratory Benefit Management Program, administered by BeaconLBS QUANTITATIVE HIV RNA (VIRAL LOAD) Policy Number: PDS - 008 Effective Date: October
More informationThe Challenges in Developing and Commercializing HIV Tests that are Useful in Differentiating VISP/R VISP/R Workshop Bethesda, MD March 2013
The Challenges in Developing and Commercializing HIV Tests that are Useful in Differentiating VISP/R VISP/R Workshop Bethesda, MD March 2013 Christopher Bentsen, M.S.,RAC, FRAPS Bio-Rad Laboratories, Redmond,
More informationHIV-1 Subtypes: An Overview. Anna Maria Geretti Royal Free Hospital
HIV-1 Subtypes: An Overview Anna Maria Geretti Royal Free Hospital Group M Subtypes A (1, 2, 3) B C D F (1, 2) G H J K Mechanisms of HIV-1 genetic diversification Point mutations RT error rate: ~1 per
More informationRNA PCR, Proviral DNA and Emerging Trends in Infant HIV Diagnosis
RNA PCR, Proviral DNA and Emerging Trends in Infant HIV Diagnosis 1 B R E N D A N M C M U L L A N I N F E C T I O U S D I S E A S E S, S Y D N E Y C H I L D R E N S H O S P I T A L S C H O O L O F W O
More informationIt takes more than just a single target
It takes more than just a single target As the challenges you face evolve... HIV mutates No HIV-1 mutation can be considered to be neutral 1 Growing evidence indicates all HIV subtypes may be prone to
More informationAccuSet Anti-HIV-1 Mixed Titer Performance Panel
PACKAGE INSERT PRB205(M3) / (0800-0379) INTENDED USE The Performance Panel PRB205(M3) / (0800-0379) is intended for use by diagnostics manufacturers and clinical laboratorians to evaluate their HIV-1 test
More informationHepatitis C Virus (RNA)A
Hepatitis C Virus (RNA)A 2012 EQA Programme Final Report QAV994112 (HCVRNA12A) Professor Jacques Izopet Scientific Expert on behalf of QCMD Report authorised by the QCMD Executive in July 2012 A UKAS accredited
More informationHIV-1 Seroconversion Panel PRB964
A SERACARE PANEL PRODUCT Seroconversion INTENDED USE The is a group of serial bleeds from an individual plasma donor during seroconversion. This is intended for use by diagnostics manufacturers and clinical
More information2006 HIV Diagnostics Survey
Public Health Laboratory Issues in Brief: 2006 HIV Diagnostics Survey Association of Public Health Laboratories November 2007 Background Nearly 20 years ago, the Association of Public Health Laboratories
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 informationQUANTITATIVE HIV RNA (VIRAL LOAD)
CLINICAL GUIDELINES For use with the UnitedHealthcare Laboratory Benefit Management Program, administered by BeaconLBS QUANTITATIVE HIV RNA (VIRAL LOAD) Policy Number: PDS - 008 Effective Date: January
More informationThe author has received speaker honoraria and travel assistance from Bio-Rad, inc.
CVI Accepted Manuscript Posted Online 2 March 2016 Clin. Vaccine Immunol. doi:10.1128/cvi.00053-16 Copyright 2016, American Society for Microbiology. All Rights Reserved. 1 Human Immunodeficiency Virus
More informationSerology and International units
Serology and International units L. Grangeot-Keros, National Reference Laboratory for Rubella, Virology Department, A. Béclère Hospital, Clamart, France Detection of rubella-specific IgG antibody Assays
More informationHIV Guideline Sakchai Dettrairat
HIV Guideline 2016 Sakchai Dettrairat Division of Clinical Immunology Department of Medical Technology Faculty of Associated Medical Sciences Chiang Mai University Appearance of HIV markers in early HIV
More informationHIV-1 Seroconversion Panel
A SERACARE PANEL PRODUCT Seroconversion INTENDED USE The Seroconversion is a group of serial bleeds from an individual plasma donor during seroconversion. This is intended for use by diagnostics manufacturers
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 informationArizona State Office of Rural Health Webinar Series
Arizona State Office of Rural Health Webinar Series Mute your phone &/or computer microphone Time is reserved at the end for Q&A Please fill out the post-webinar survey Webinar is being recorded Recording
More informationDiagnosis and Management of Acute HIV
Diagnosis and Management of Acute HIV A New HIV Diagnosis is a Call to Action In support of the NYSDOH AIDS Institute s January 2018 call to action for patients newly diagnosed with HIV, this committee
More informationAbility to Identify Acute HIV Infections from Surveillance Data Varies by Diagnostic Testing Algorithm
Ability to Identify Acute HIV Infections from Surveillance Data Varies by Diagnostic Testing Algorithm Laurie Linley, MPH; Anne H. Peruski, MPH, PhD; Richard M. Selik, MD; Kevin P. Delaney, MPH, PhD; Alexandra
More informationWhich of the Two Make the Best Soul Mate: An Autoantibody, Antibody or Antigen? Maria Crisostomo, September 28, 2018
Which of the Two Make the Best Soul Mate: An Autoantibody, Antibody or Antigen? Maria Crisostomo, September 28, 2018 Disclosure Employee and stock holder of Bio-Rad Laboratories 2 Outline At the completion
More informationdetection of HIV-1/2 antibodies
CVI Accepts, published online ahead of print on 18 June 214 Clin. Vaccine Immunol. doi:1.1128/cvi.153-14 Copyright 214, American Society for Microbiology. All Rights Reserved. 1 2 Evaluation of Bio-Rad
More informationFailure of the Alere Determine 4th Generation HIV POC test to Detect an Acute Case of HIV-1 Infection
Failure of the Alere Determine 4th Generation HIV POC test to Detect an Acute Case of HIV-1 Infection Carol Loring, MS Rachel Gridley Fengxiang Gao, MD, MPH NH Public Health Laboratories Concord, NH Conflicts
More informationObjectives. Seven days of separation. Clinical situation a transplant. The Donor COOMBS MD PHD 1. Laboratory Diagnosis & Monitoring of HIV Infection
Laboratory Diagnosis & Monitoring of HIV Infection An Introduction to Diagnostic HIV Testing Robert W Coombs MD, PhD, FRCPC Professor, Departments of Laboratory Medicine & Medicine University of Washington,
More informationSchedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Royal Liverpool & Broadgreen University Hospitals NHS Trust Department of Virology Liverpool Clinical Laboratories Royal Liverpool and Broadgreen
More informationSEROLOGICAL DIAGNOSIS OF VIRAL INFECTIONS:
SEROLOGICAL DIAGNOSIS OF VIRAL INFECTIONS: POSSIBILITIES OF SEROLOGICAL DIAGNOSIS TYPES OF SEROLOGICAL REACTIONS SEROLOGICAL REACTIONS Ag-Ab reactions used for the detection of unknown Ag or Ab, in vitro
More informationThis work is licensed under a Creative Commons Attribution- NonCommercial-NoDerivatives 4.0 International License.
Title Current assays for HIV-1 diagnostics and antiretroviral therapy monitoring: challenges and possibilities Author(s) To, SWC; Chen, JHK; Yam, WC Citation Future Virology, 2013, v. 8 n. 4, p. 405-419
More informationCalibration and stability of WHO and secondary viral standards
Calibration and stability of WHO and secondary viral standards Nico Lelie, Harry van Drimmelen and the International NAT Study Group Facilities DDL Diagnostic Laboratories Outline Calibration of WHO and
More informationHow are testing technologies used to diagnose HIV infection?
HIV testing technologies are used to determine if a person has HIV. Several types of HIV testing technologies are used in Canada. These tests differ in several ways, including where the test is conducted,
More informationReview. Laboratory Methods for Diagnosis and Management of Hepatitis C Virus Infection
Laboratory Methods for Diagnosis and Management of Hepatitis C Virus Infection Muhammad Amjad, PhD, 1* Varsha Moudgal, MD, 2 Muhammad Faisal, MD 3 ABSTRACT Hepatitis C virus (HCV) infection is associated
More informationCMV Diagnostic Strategies: Current and Future
CMV Diagnostic Strategies: Current and Future Tony Mazzulli, MD, FRCPC, FACP Microbiologist-in-Chief Mount Sinai Hospital & University Health Network, Toronto Faculty/Presenter Disclosure Relationships
More informationConsolidated Donor Funded Procurement of HIV Diagnostics
Consolidated Donor Funded Procurement of HIV Diagnostics Meeting on HIV Diagnostic Global Demand Forecast Geneva, 9 April 2015 Mercedes Perez Gonzalez Prequalification Team Diagnostics Assessment Department
More information