Performance evaluation of a point-of-care whole blood viral load test (SAMBA II HIV-1 Semi-Q Whole Blood) to optimise HIV treatment

2016 ◽  
Author(s):  
Sarah Oakley-Mudge
Keyword(s):  
Performance Evaluation ◽  
Viral Load ◽  
Whole Blood ◽  
Point Of Care ◽  
Hiv Treatment ◽  
Load Test ◽  
Viral Load Test ◽  
Hiv 1 ◽  
Blood Viral Load

Performance and usability of mPIMA™ HIV 1/2 viral load test in point of care settings in Kenya

2019 ◽  
Vol 121 ◽  
pp. 104202
Author(s):  
Priska Bwana ◽  
Joshua Ageng’o ◽  
Jeff Danda ◽  
Joseph Mbugua ◽  
Allan Handa ◽  
...  
Keyword(s):  
Viral Load ◽  
Point Of Care ◽  
Load Test ◽  
Viral Load Test ◽  
Hiv 1

scholarly journals Study to evaluate the performance of a point-of-care whole blood HIV viral load test (SAMBA II HIV-1 Semi-Q Whole Blood).

2020 ◽  
Author(s):  
Gary Brook ◽  
Tetiana Stepchenkova ◽  
Innocent M. Ali ◽  
Sandra Chipuka ◽  
Neha Goel ◽  
...  
Keyword(s):  
Viral Load ◽  
Whole Blood ◽  
Point Of Care ◽  
Venous Blood ◽  
Load Test ◽  
Hiv Viral Load ◽  
Percent Agreement ◽  
Finger Prick ◽  
Hiv 1 ◽  
Point Of Care Assay

Remote areas of many low and middle income (LMI) countries have poor access to HIV viral load (HIV VL) testing. The SAMBA-II (Simple Amplification-based Assay) Semi-Q Whole Blood Test (Diagnostics for the Real World (DRW), Cambridge, UK) is a point of care assay which uses leucodepletion technology to allow whole blood testing in remote settings. 1540 consecutive HIV-positive clinic patients in Cameroon (250), UK (633), Ukraine (412) and Zimbabwe (245) donated venous blood (all countries) and finger-prick blood (all except UK) for testing on SAMBA-II. SAMBA II results were compared with simultaneous plasma results on the Abbott RealTime HIV-1 (Abbott Molecular, Des Plaines, IL) viral load assay and interpreted as either <1000 RNA copies/ml or ≥1000 RNA copies/ml. For 1528 venous whole-blood samples tested on SAMBA II, overall percent agreement with the reference test at a cut-off of HIV VL ≥1000 cps/ml was 96.9% (1480/1528 95% CI 95.9-97.7), negative percent agreement 97.7% (1259/1289 95% CI 96.7-98.4), positive percent agreement 92.5% (221/239 95% CI 88.4-95.5). For 854 finger-prick samples there was 95.0% (811/854 95% CI 93.3-96.3) overall percent agreement; negative percent agreement 98.0% (625/638, 95% CI 96.5-98.9); positive percent agreement 86.1% (186/216 95% CI 80.8-90.4). These rose to 93.5% (82.1, 98.6), 97.6% (95.6, 98.8) and 95.6% (93.3, 97.3) after exclusion of aberrant results from the Ukraine centre. These results show a high level of agreement between SAMBA-II and a laboratory-based assay. SAMBA-II has a performance that is suitable to use as a VL point of care assay in remote settings

Validity of a point-of-care viral load test for hepatitis B in a low-income setting

2021 ◽  
Vol 289 ◽  
pp. 114057
Author(s):  
Gezahegn Mekonnen Woldemedihn ◽  
Corina Silvia Rueegg ◽  
Hailemichael Desalegn ◽  
Hanna Aberra ◽  
Nega Berhe ◽  
...  
Keyword(s):  
Viral Load ◽  
Hepatitis B ◽  
Low Income ◽  
Point Of Care ◽  
Load Test ◽  
Viral Load Test ◽  
Low Income Setting

scholarly journals Performance evaluation of the point-of-care SAMBA I and II HIV-1 Qual whole blood tests

2016 ◽  
Vol 237 ◽  
pp. 143-149 ◽  
Author(s):  
Allyson V. Ritchie ◽  
Neha Goel ◽  
Hiroshi Sembongi ◽  
Jesse Lehga ◽  
Laura E. Farleigh ◽  
...  
Keyword(s):  
Performance Evaluation ◽  
Whole Blood ◽  
Point Of Care ◽  
Blood Tests ◽  
Hiv 1

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.

scholarly journals Point-of-Care Early Infant Diagnosis Improves Adherence to the Testing Algorithm in Kenya

2020 ◽  
Vol 19 ◽  
pp. 232595822090603
Author(s):  
Collins Otieno Odhiambo ◽  
George Githuka ◽  
Nancy Bowen ◽  
Leonard Kingwara ◽  
Jared Onsase ◽  
...  
Keyword(s):  
Viral Load ◽  
Point Of Care ◽  
Load Test ◽  
Baseline Viral Load ◽  
Early Infant Diagnosis ◽  
Confirmatory Testing ◽  
Subsequent Test ◽  
Early Infant ◽  
Viral Load Test ◽  
Testing Algorithm

Introduction: We determine the level of adherence to the revised Kenya early infant diagnosis (EID) algorithm during implementation of a point-of-care (POC) EID project. Methods: Data before (August 2016 to July 2017) and after (August 2017 to July 2018) introduction of POC EID were collected retrospectively from the national EID database and registers for 33 health facilities. We assessed the number of HIV-infected infants who underwent confirmatory testing and received baseline viral load test and proportion of infants with an initial negative result who had a subsequent test. Results and Discussion: Significantly higher number of infants accessed confirmatory testing (94.2% versus 38.6%; P < .0001) with POC EID. Baseline viral load test and follow-up testing at 6 months, although higher with POC EID, were not significantly different from the pre-POC EID intervention period. Conclusion: The POC EID implementation has the potential to increase proportion of infants who receive confirmatory testing, thus reducing the risk of false-positive results.

RNA Viral Load Test for Early Diagnosis of Vertical Transmission of HIV-1 Infection

2000 ◽  
Vol 23 (4) ◽  
pp. 358-360 ◽  
Author(s):  
Inara Espinelli Souza ◽  
M. Lucia Azevedo ◽  
Regina C. Succi ◽  
Daisy M. Machado ◽  
Ricardo S. Diaz
Keyword(s):  
Viral Load ◽  
Early Diagnosis ◽  
Vertical Transmission ◽  
Load Test ◽  
Viral Load Test ◽  
Vertical Transmission Of Hiv ◽  
Hiv 1

scholarly journals Point-of-Care Cepheid Xpert HIV-1 Viral Load Test in Rural African Communities Is Feasible and Reliable

2016 ◽  
Vol 54 (12) ◽  
pp. 3050-3055 ◽  
Author(s):  
Sikhulile Moyo ◽  
Terence Mohammed ◽  
Kathleen E. Wirth ◽  
Melanie Prague ◽  
Kara Bennett ◽  
...  
Keyword(s):  
Viral Load ◽  
Point Of Care ◽  
Load Test ◽  
Combination Prevention ◽  
Promising Tool ◽  
Routine Monitoring ◽  
Prevention Project ◽  
The Difference ◽  
Blood Specimens ◽  
Hiv 1

Routine monitoring of HIV-1 RNA or viral load (VL) in patients on antiretroviral therapy (ART) is important, but there are multiple impediments to VL testing in resource-constrained settings. An accurate point-of-care (POC) HIV-1 VL test could alleviate many of these challenges. We compared the performance of the Cepheid Xpert HIV-1 VL assay against the laboratory-based Abbott m 2000sp/ m 2000rt assay (Abbott assay). ART-naive individuals participating in the Botswana Combination Prevention Project in 20 communities provided EDTA-blood specimens during household surveys. Both the POC Xpert HIV-1 VL and Abbott assays were performed on specimens sampled from 277 individuals. We found a high correlation between the Xpert HIV-1 VL and Abbott assay results ( r 2 = 0.92; P < 0.001). The overall mean difference in the HIV-1 RNA values obtained by Xpert HIV-1 VL assay and Abbott assay was 0.34 log 10 copies/ml (95% confidence interval [CI], 0.26 to 0.40 log 10 copies/ml) ( P < 0.001). Using a clinically relevant level of 1,000 copies/ml as a threshold, agreement was 90.6% (95% CI, 87.9 to 93.1%), with a sensitivity of 98.6% (95% CI, 97.2 to 100%). The two methods agreed on their detectability of HIV-1 RNA (>40 copies/ml) at 97.1% (95% CI, 95.5 to 98.7%), with a sensitivity of 99.6% (95% CI, 97.2 to 100%). The POC Cepheid Xpert HIV-1 VL assay showed high agreement and accuracy with a laboratory-based method of HIV-1 RNA testing. The POC Xpert HIV-1 VL assay tended to overestimate HIV-1 VL, although the difference was below a clinically relevant threshold of 0.5 log 10 copies/ml. The POC Cepheid Xpert HIV-1 VL assay is a promising tool for monitoring patients on ART in southern Africa.

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