Implementation and operational feasibility of SAMBA I HIV‐1 semi‐quantitative viral load testing at the point‐of‐care in rural settings in Malawi and Uganda

2020 ◽  
Author(s):  
Monique Gueguen ◽  
Sarala Nicholas ◽  
Elisabeth Poulet ◽  
Birgit Schramm ◽  
Elisabeth Szumilin ◽  
...  
Keyword(s):  
Viral Load ◽  
Point Of Care ◽  
Load Testing ◽  
Viral Load Testing ◽  
Rural Settings ◽  
Hiv 1

Evaluation of the use of plasma preparation tubes for HIV viral load testing on the COBAS AmpliPrep/COBAS TaqMan HIV-1 version 2.0

2013 ◽  
Vol 187 (2) ◽  
pp. 248-250 ◽  
Author(s):  
Dominique Goedhals ◽  
Lesley E. Scott ◽  
Serena Moretti ◽  
Mark A. Cooper ◽  
Willem J.L. Opperman ◽  
...  
Keyword(s):  
Viral Load ◽  
Load Testing ◽  
Hiv Viral Load ◽  
Cobas Taqman ◽  
Viral Load Testing ◽  
Version 2.0 ◽  
Hiv 1

scholarly journals The Development of a Standardized Quality Assessment Material to Support Xpert HIV-1 Viral Load Testing for ART Monitoring in South Africa

2020 ◽  
Author(s):  
Lara Dominique Noble ◽  
Lesley Erica Scott ◽  
Asiashu Bongwe ◽  
Pedro Da Silva ◽  
Wendy Susan Stevens
Keyword(s):  
South Africa ◽  
Viral Load ◽  
Quality Assessment ◽  
Molecular Transport ◽  
Load Testing ◽  
Hiv Viral Load ◽  
Viral Load Testing ◽  
Load Monitoring ◽  
Edta Plasma ◽  
Hiv 1

The tiered laboratory framework for HIV viral load monitoring accommodates a range of HIV viral load testing platforms, with quality assessment critical to ensure quality patient testing. HIV plasma viral load testing is challenged by the instability of viral RNA. An approach using an RNA stabilizing buffer is described for the Xpert HIV-1 Viral Load (Cepheid) assay and was tested in remote laboratories in South Africa. EDTA-plasma panels with known HIV viral titres was prepared in PrimeStore molecular transport medium for per-module verification and per-instrument external quality assessment. The panels were transported at ambient temperature to 13 testing laboratories during 2017-2018, tested according to standard procedures and uploaded to a web portal for analysis A total of 275 quality assessment specimens (57 verification panels and two EQA cycles) were tested. All participants passed verification (n=171 specimens) with an overall concordance correlation (ρc) of 0.997 (95%confidence interval [CI]:0.996,0.998) and a mean log bias of -0.019log cp/mL (95%CI:-0.044,0.063). The overall EQA ρc (n=104 specimens) was 0.999 (95%CI:0.998,0.999), with a mean log bias of 0.03 log cp/mL 95%(CI:0.02,0.05). The panels are suitable for use in quality monitoring of Xpert HIV-1 VL and are applicable to laboratories in remote settings.

scholarly journals Quality of Human Immunodeficiency Virus Viral Load Testing in Australia

2000 ◽  
Vol 38 (11) ◽  
pp. 4015-4020 ◽  
Author(s):  
Susan J. Best ◽  
Anthony P. Gust ◽  
Elizabeth I. M. Johnson ◽  
Catherine H. McGavin ◽  
Elizabeth M. Dax
Keyword(s):  
Human Immunodeficiency Virus ◽  
Viral Load ◽  
Load Testing ◽  
Viral Load Testing ◽  
Subtype B ◽  
Immunodeficiency Virus ◽  
Total Variability ◽  
Clinically Significant ◽  
Hiv 1

This study determined the proficiencies of laboratories measuring human immunodeficiency virus type 1 (HIV-1) viral loads and the accuracies of two assays used for HIV-1 viral load measurement in Australia and investigated the variability of the new versions of these assays. Quality assessment program panels containing (i) dilutions of HIV-1 subtype B, (ii) replicates of identical samples of HIV-1 subtype B, and (iii) samples of subtype E and B were tested by laboratories. Total variability (within and between laboratories) was tested with quality control samples. The coefficients of variation (CVs) for the Roche AMPLICOR HIV-1 MONITOR version (v) 1.0 and Chiron Quantiplex bDNA 2.0 assays ranged from 53 to 87% and 22 to 31%, respectively. The widespread occurrence of invalid runs with the AMPLICOR HIV-1 MONITOR 1.0 assay was identified. The CVs of the new versions of the assays were 82 to 86% for the AMPLICOR HIV-1 MONITOR v 1.5 assay and 16 to 23% for the Quantiplex bDNA 3.0 assay. For virus dilution samples, all but 5 of 19 laboratories obtained results within 2 standard deviations of the mean. The Quantiplex bDNA 2.0 assay reported values lower than those reported by the AMPLICOR HIV-1 MONITOR version 1.0 assay for samples containing HIV-1 subtype B, whereas the reverse was true for subtype E. Identification and resolution of the problem of invalid runs markedly improved the quality of HIV-1 viral load testing. The variability observed between laboratories and between assays, even the most recent versions, dictates that monitoring of viral load in an individual should always be by the same laboratory and by the same assay. Results for an individual which differ by less than 0.5 log10 HIV-1 RNA copy number/ml should not be considered clinically significant.

Evaluation of two commercially available alternatives for HIV-1 viral load testing in resource-limited settings

2007 ◽  
Vol 146 (1-2) ◽  
pp. 178-187 ◽  
Author(s):  
Kim Steegen ◽  
Stanley Luchters ◽  
Nancy De Cabooter ◽  
Jacqueline Reynaerts ◽  
Kishor Mandaliya ◽  
...  
Keyword(s):  
Viral Load ◽  
Load Testing ◽  
Resource Limited Settings ◽  
Viral Load Testing ◽  
Resource Limited ◽  
Hiv 1

scholarly journals Whatman FTA cards versus plasma specimens for the quantitation of HIV-1 RNA using two real-time PCR assays

2020 ◽  
Vol 2 (8) ◽  
Author(s):  
Abdourahamane Yacouba ◽  
Malika Congo ◽  
Gérard Komonsira Dioma ◽  
Hermann Somlare ◽  
David Coulidiaty ◽  
...  
Keyword(s):  
Viral Load ◽  
Real Time ◽  
Filter Paper ◽  
Real Time Pcr ◽  
Load Testing ◽  
Viral Loads ◽  
Viral Load Testing ◽  
Fta Cards ◽  
Pcr Assays ◽  
Hiv 1

Background. Several studies have compared the use of dried blot spot (DBS) as an alternative to plasma specimens, mainly using Whatman 903 cards as filter paper. The aim of this study was to evaluate the use of Whatman FTA card (FTA card) specimens for HIV-1 viral load testing compared to plasma specimens using two real-time PCR assays manufactured by Roche and Abbott. Methodology. A cross-sectional study was conducted between April 2017 and September 2017 on HIV-1 patients admitted to Yalgado Ouédraogo Teaching Hospital. Paired FTA cards and plasma specimens were collected and analysed using the Abbott Real-Time HIV-1 assay (Abbott) and COBAS AmpliPrep/COBAS TaqMan v2.0 (Roche). Results. In total, 107 patients were included. No statistical differences (P>0.05) were observed between the mean viral loads obtained from the FTA cards and those of the plasma specimens using the Roche and Abbott assays. In total, 29 samples with Roche and 15 samples with Abbott assay showed discrepant results. At viral loads of ≤1000 copies ml−1, the sensitivity and specificity of the FTA cards were 78.6 and 100% with Roche, and 92.3 and 95.9% with Abbott, respectively. Both the Roche and Abbott assays showed good correlation and agreement between the FTA cards and plasma values. Conclusion. Our study demonstrates the feasibility of using FTA card filter paper for HIV-1 viral load testing. However, further studies will be required for the validation of the use of FTA card filter paper in HIV-1 treatment monitoring.

Viral Load Test Reports

2001 ◽  
Vol 125 (12) ◽  
pp. 1546-1554
Author(s):  
Diane P. Francis ◽  
K. Michael Peddecord ◽  
Louise K. Hofherr ◽  
J. Rex Astles ◽  
William O. Schalla
Keyword(s):  
Viral Load ◽  
Telephone Survey ◽  
Health Department ◽  
Load Test ◽  
Load Testing ◽  
Test Results ◽  
Viral Load Testing ◽  
Viral Load Test ◽  
Test Kit ◽  
Hiv 1

Abstract Context.— Human immunodeficiency virus (HIV) RNA testing (viral load testing) is increasingly important in the care of patients infected with HIV-1 to determine when to initiate, monitor, and change antiretroviral therapy. Patient viral load testing information is communicated to the clinician through the laboratory test report. Objectives.—To examine the format and information used in reporting viral load testing results and determine the clarity of the information provided in these reports. Design.—Patient test reports with all personal identifiers removed were requested of viral load testing laboratories participating in a telephone survey of laboratory practices. Hospital, independent, health department, and “other type” laboratories identified as university-associated laboratories participated in the telephone survey. Results.—Thirty-seven unique test reports were collected. All laboratories reported results in copies/mL, while 14% also reported results as “log10 copies/mL.” The test kit was identified by only 24% of the laboratories. Reportable ranges were specified by 70% of the laboratories, but there was considerable variation in terminology. One laboratory reported a viral load copy number below the manufacturer's test kit lower limit of sensitivity. The layout and format differed among reports. Some results were expressed in log10, others contained nonsignificant integers, while others contained exponential numbers. Supplemental information in some reports included previous patient test results and significance of changes from baseline. The format of some reports made it difficult to read the report information and interpret the testing results. Conclusion.—This study emphasizes the importance of standardizing the reporting of HIV-1 viral load test results to minimize result misinterpretation and incorrect treatment.

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