Evaluation of four commercial virological assays for early infant HIV-1 diagnosis using dried blood specimens

Álvarez, Patrícia; Prieto, Luís; Martín, Leticia; Obiang, Jacinta; Avedillo, Pedro; Vargas, Antonio; Rojo, Pablo; McPhee, Carolina Fernández; Canalejas, Leticia Sanz; Benito, Agustín; Ramos, José Tomás; Holguín, África

doi:10.1038/pr.2016.183

Cited by 12 publications

(6 citation statements)

References 37 publications

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“…Nurses in two primary healthcare centres performed the collection of the cobas 1 PSC specimens for this study, attesting to the feasibility of implementing this new method in resourcelimited health systems. The procedures for collecting cobas 1 PSC specimens are similar to those for DBS, which health professionals throughout sub-Saharan Africa have been using in HIV viral load testing and early infant diagnosis for many years [6,[8][9][10]. Additionally, in this study viral load testing using cobas 1 PSC specimens was executed in a laboratory that routinely tests for viral load and early infant diagnosis, with no additional equipment required.…”

Section: Discussionmentioning

confidence: 99%

“…Whole capillary or venous blood is spotted onto filter paper cards to prepare DBS. This method of whole blood collection has been very successfully implemented for diagnosing HIV-infection among infants younger than 18 months through the qualitative detection of HIV-1 proviral DNA [8][9][10]. The comparative advantages of DBS include their ease of transportation, lack of cold chain needs and low biosafety requirements.…”

Section: Introductionmentioning

confidence: 99%

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Accurate HIV viral load measurement in primary health care settings using the cobas® plasma separation card

et al. 2020

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Introduction Plasma is considered the gold standard for HIV viral load (VL) testing, however its use is challenging due to the need for phlebotomy and centrifugation services, as well as cold chain for transporting to laboratories for testing. The use of Dried Blood Spot (DBS) specimen has allowed a rapid expansion of antiretroviral therapy (ART) monitoring in remote areas in many African countries, however, the VL in DBS may overestimate the copies of viral RNA result at the clinically relevant range of 1000 copies/ml, due to proviral DNA and intracellular RNA. The characteristics of the cobas ® Plasma Separation Card (PSC) specimen are similar to fresh plasma (gold standard), so a better performance of HIV VL is expetected in PSC specimen and can be an alternative to DBS. This study aims to evaluate the performance of cobas ® PSC for VL testing at primary health care facilities in Mozambique. Methodology HIV-1 infected adults on ART were enrolled consecutively in two health facilities in Mozambique, between August 2018 and October 2018. Capillary and venous cobas ® PSC, DBS and fresh plasma specimens were collected from each patient. All specimens were tested for VL using CAP/CTM v2.0. Sensitivity and specificity of viral load using DBS, capillary and venous PSC specimens were estimated. Viral load obtained in fresh plasma specimen was used as reference and a threshold of 1000 copies/ml was considered for the analyses. Results From the total 613 patients included for the study, 2444 specimens including DBS (613), plasma (613), venous cobas ® PSC (609) and capillary cobas ® PSC (609) were collected and 2407 results were obtained. Sensitivity and specificity of the VL using venous cobas ® PSC specimen at 1000 copies/ml threshold were 99.8% and 98.1% respectively, whereas for capillary cobas ® PSC sensitivity was 99.6% and specificity was 97.2%. For DBS VL, sensitivity was 96.9% and specificity was 81.8%. Misclassification rate was more prominent in DBS

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Accurate HIV viral load measurement in primary health care settings using the cobas® plasma separation card

et al. 2020

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“…Previous studies have reported discordant or false‐positive values using molecular technologies, either qualitative or quantitative assays . While there is a correlation between the cycle threshold value and the level of virus in a sample, the various circulating viral subtypes, assay techniques, and use of older technologies can led to discordant PCR results.…”

Section: Discussionmentioning

confidence: 99%

Viral load assay performs comparably to early infant diagnosis assay to diagnose infants with HIV in Mozambique: a prospective observational study

et al. 2020

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Introduction Viral load testing is essential to manage HIV disease, especially in infants and children. Early infant diagnosis (EID) is performed using nucleic‐acid testing in children under 18 months. Resource‐limited health systems face severe challenges to scale‐up both viral load and EID to unprecedented levels. Streamlining laboratory systems would be beneficial to improve access to quality testing and to increase efficiency of antiretroviral treatment programmes. We evaluated the performance of viral load testing to serve as an EID assay in children younger than 18 months. Methods This study was an observational, prospective study, including children between one and 18 months of age who were born to HIV‐positive mothers in 134 health facilities in Maputo City and Maputo Province, Mozambique. Dried blood spot specimens from heel or toe pricks were collected between January and April 2018, processed using SPEX buffer for both assays, and tested for routine EID and viral load testing using the Roche CAP/CTM HIV‐1 Qualitative v2 and Roche CAP/CTM HIV‐1 Quantitative v2 assays respectively. The sensitivity, specificity and positive and negative predictive values were estimated using the EID results as the reference standard. Results A total of 1021 infants were included in the study, of which 47% were female. Over 95% of mothers and children were on antiretroviral treatment or received antiretroviral prophylaxis respectively. The sensitivity and specificity of using the viral load assay to detect infection were 100% (95% CI: 96.2 to 100%) and 99.9% (95% CI: 99.4 to 100%). The positive and negative predictive values were 99.0% (95% CI: 94.3 to 100%) and 100% (95% CI: 99.6 to 100%). The McNemar’s test was 1.000 and Cohen’s kappa was 0.994. Conclusions The comparable performance suggests that viral load assays can be used as an infant diagnostic assay. Infants with either low levels of viraemia or high cycle threshold values should be repeat tested to ensure the result is truly positive prior to treatment initiation, regardless of assay used. Viral load assays could replace traditional EID testing, substantially streamlining molecular laboratory services for children and lowering costs, with the additional advantage of providing baseline viral load results for antiretroviral treatment management.

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“…In an evaluation of four commercial virological assays for early infant HIV-1 diagnosis using dried blood specimens, these tests were all useful for EID, although discrepant results were common [16]. These studies advocate further research to reduce false-positive results that could lead to false diagnosis and unnecessary treatment, and that caution should be exercised in interpreting the results of quantitative PCR with low viral load (VL) values and in developing guidelines for the management of cases with discordant virological findings [15,16].…”

Section: What Early Diagnosismentioning

confidence: 99%

Assessment of the Early Infant Diagnosis of HIV Infection in Togo in 2014

Azoumah¹,

Agbeko²,

Kar³

et al. 2017

J AIDS Clin Res

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Evaluation of four commercial virological assays for early infant HIV-1 diagnosis using dried blood specimens

Cited by 12 publications

References 37 publications

Accurate HIV viral load measurement in primary health care settings using the cobas® plasma separation card

Accurate HIV viral load measurement in primary health care settings using the cobas® plasma separation card

Viral load assay performs comparably to early infant diagnosis assay to diagnose infants with HIV in Mozambique: a prospective observational study

Assessment of the Early Infant Diagnosis of HIV Infection in Togo in 2014

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