Correlation between HIV-1 viral load quantification in plasma, dried blood spots, and dried plasma spots using the Roche COBAS Taqman assay

Andreotti, Mauro; Pirillo, Maria Franca; Guidotti, Giovanni; Ceffa, Susanna; Paturzo, Giovanna; Germano, Paola; Luhanga, Richard; Chimwaza, D; Mancini, Maria Grazia; Marazzi, Maria Cristina; Vella, Stefano; Palombi, Leonardo; Giuliano, Marina

doi:10.1016/j.jcv.2009.11.006

Cited by 45 publications

(49 citation statements)

References 15 publications

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“…8,10 The results with bDNA reported here are consistent and modestly improved from our previous results using this assay, which indicated that HIV-1 viral load levels were approximately 0.5 log 10 copies/mL lower than those obtained from frozen samples. 8 Although the overall correlation between frozen and dried samples was good (within 0.3 log 10 /mL) and consistent with differences seen with DBS, 11,12 there were some samples around the lower limit of detection that resulted in false negative or positive results. However, all discordant HIV-1 viral load results were no greater than 200 copies/mL.…”

Section: Discussionsupporting

confidence: 59%

Comparative effectiveness of dried plasma HIV-1 viral load testing in Brazil using ViveST for sample collection

Zanoni

Cortes

Diaz

et al. 2010

Journal of Clinical Virology

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Section: Discussionsupporting

confidence: 59%

Comparative effectiveness of dried plasma HIV-1 viral load testing in Brazil using ViveST for sample collection

Zanoni

Cortes

Diaz

et al. 2010

Journal of Clinical Virology

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“…The CAP/ CTM also facilitates efficient processing and high throughput of specimens to allow laboratories to rapidly quantify HIV load in large numbers of specimens (21). A high degree of correlation in HIV-1 viral load measurement between plasma and DBS specimens has been reported using the CAP/CTM assay (22). The CAP/CTM has not been widely adopted in Kenya or across sub-Saharan Africa, with the exception of South Africa (23).…”

mentioning

confidence: 99%

Evaluation of Quantification of HIV-1 RNA Viral Load in Plasma and Dried Blood Spots by Use of the Semiautomated Cobas Amplicor Assay and the Fully Automated Cobas Ampliprep/TaqMan Assay, Version 2.0, in Kisumu, Kenya

et al. 2013

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dIn Kenya, HIV-1 viral load monitoring is commonly performed with the Cobas Amplicor using plasma specimens. Interest is growing in transitioning to real-time PCR (RT-PCR), such as the Cobas Ampliprep/Cobas TaqMan (CAP/CTM), using dried blood spots (DBS). Before implementation, direct evaluation of the two assays using DBS field specimens is required. This study compares the sensitivity, specificity, negative and positive predictive values (NPV and PPV, respectively), concordance, and agreement between HIV-1 viral load measurements using plasma and DBS specimens obtained from 512 HIV-1-infected pregnant females enrolled in the Kisumu Breastfeeding Study and tested with the Cobas Amplicor and CAP/CTM assays. The sensitivity and NPV of viral load detection in DBS specimens were higher with CAP/CTM (sensitivity, 100%; 95% confidence interval [CI], 99.1 to 100.0%; NPV, 100%; 95% CI, 59.0 to 100.0%) than the Cobas Amplicor (sensitivity, 96.6%; 95% CI, 94.3 to 98.1%; NPV, 58.8%; 95% CI, 40.7 to 75.4%). The PPVs were comparable between both assays when using DBS. The specificity of viral load detection in DBS specimens was lower with CAP/CTM (77.8%; 95% CI, 40.0 to 97.2%) than that of the Cobas Amplicor (95.2%; 95% CI, 76.2 to 99.9%). Good concordance and agreement were observed when paired plasma and DBS specimens were tested with both assays. Lower specificity with the CAP/CTM is likely due to proviral HIV-1 DNA amplification and lower detection limits with RT-PCR. However, the CAP/CTM has better sensitivity and higher throughput than the Cobas Amplicor. These findings suggest that DBS may be a suitable alternative to plasma when using RT-PCR, which could increase access to viral load monitoring in resource-limited settings.

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“…DBS can be easily collected and stored without being frozen or refrigerated (2,17,22). Several studies have demonstrated the feasibility of DBS as a specimen type for VL testing using different methodologies, although limitations in terms of sensitivity and stability have been noted (3,5,9,10,12,16). In addition, the recognition of distinct subtypes is an important problem in countries where HIV variability is high, and some VL assays occasionally underquantify some variants (19,24).…”

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confidence: 99%

Comparison of HIV-1 RNA Measurements Obtained by Using Plasma and Dried Blood Spots in the Automated Abbott Real-Time Viral Load Assay

Arredondo¹,

Garrido²,

Parkin

et al. 2012

J Clin Microbiol

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c Dried blood spots (DBS) may be a promising alternative specimen type to plasma for measuring the viral load (VL) in HIVinfected individuals in resource-limited settings. However, characterization of assay performance using DBS is incomplete. In this prospective study, the VL was measured in parallel using plasma and DBS specimens collected at the same time from 157 HIV-1-infected individuals. DBS were prepared by dispensing 50 l of blood onto filter paper cards and were stored desiccated at ؊20°C. Nucleic acid extraction from plasma and DBS was performed automatically using the Abbott m2000sp instrument, and the VL was measured using the RealTime HIV-1 VL assay, which has a lower limit of detection of 40 HIV RNA copies/ml. The correlation between plasma and DBS results was good (R ‫؍‬ 0.91; P < 0.001). The mean difference in the VL (DBS minus plasma) was 0.35 log copies (standard deviation [SD], 0.47 log copies). A total of 40 (26%) paired specimens had a difference of >0.5 log copy, and in 12 (7.8%) it was >1 log copy. the VL from DBS was measurable in 95.7% of specimens with a plasma VL of >2.74 log copies (550 HIV RNA copies/ml). In summary, the VL can reliably be measured using DBS with the Abbott RealTime HIV-1 assay. The estimated lower limit of detection of this automated methodology on DBS is 550 copies/ml, a threshold that may be acceptable for periodic VL monitoring in patients on antiretroviral therapy in resource-limited settings, where early detection of virologic treatment failure is often problematic. P eriodic measurement of the viral load (VL) in plasma remains a key parameter in the follow-up of HIV-infected individuals, especially those on antiretroviral therapy (ART) (21). However, reliable VL testing in plasma requires specialized facilities that often are not available in resource-poor settings. Dried blood spots (DBS) may be an interesting alternative to plasma for periodic VL testing (1,5,7,9,12,23). DBS can be easily collected and stored without being frozen or refrigerated (2,17,22). Several studies have demonstrated the feasibility of DBS as a specimen type for VL testing using different methodologies, although limitations in terms of sensitivity and stability have been noted (3,5,9,10,12,16). In addition, the recognition of distinct subtypes is an important problem in countries where HIV variability is high, and some VL assays occasionally underquantify some variants (19,24).In a previous study, we reported the results of VL testing on DBS using the Abbott mSample preparation system, a manual RNA isolation method. Although the correlation with plasma values was acceptable, the sensitivity was significantly lower on DBS (ϳ3.5 log copies) (11). Improvements in the detection limit (similar to plasma values of ϳ400 copies/ml) are important for early recognition of virological failure in patients on antiretroviral treatment. Here, we evaluate the feasibility of using an automated RNA isolation method, m2000sp, and the Abbott RealTime HIV-1 VL assay to quantify HIV-1 RNA on DBS and compar...

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Correlation between HIV-1 viral load quantification in plasma, dried blood spots, and dried plasma spots using the Roche COBAS Taqman assay

Cited by 45 publications

References 15 publications

Comparative effectiveness of dried plasma HIV-1 viral load testing in Brazil using ViveST for sample collection

Comparative effectiveness of dried plasma HIV-1 viral load testing in Brazil using ViveST for sample collection

Evaluation of Quantification of HIV-1 RNA Viral Load in Plasma and Dried Blood Spots by Use of the Semiautomated Cobas Amplicor Assay and the Fully Automated Cobas Ampliprep/TaqMan Assay, Version 2.0, in Kisumu, Kenya

Comparison of HIV-1 RNA Measurements Obtained by Using Plasma and Dried Blood Spots in the Automated Abbott Real-Time Viral Load Assay

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