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

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.

2019 ◽  
Vol 121 ◽  
pp. 104202
Author(s):  
Priska Bwana ◽  
Joshua Ageng’o ◽  
Jeff Danda ◽  
Joseph Mbugua ◽  
Allan Handa ◽  
...  

2013 ◽  
Vol 187 (2) ◽  
pp. 248-250 ◽  
Author(s):  
Dominique Goedhals ◽  
Lesley E. Scott ◽  
Serena Moretti ◽  
Mark A. Cooper ◽  
Willem J.L. Opperman ◽  
...  

Author(s):  
Lara Dominique Noble ◽  
Lesley Erica Scott ◽  
Asiashu Bongwe ◽  
Pedro Da Silva ◽  
Wendy Susan Stevens

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.


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

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.


2007 ◽  
Vol 146 (1-2) ◽  
pp. 178-187 ◽  
Author(s):  
Kim Steegen ◽  
Stanley Luchters ◽  
Nancy De Cabooter ◽  
Jacqueline Reynaerts ◽  
Kishor Mandaliya ◽  
...  

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