Can visual interpretation of NucliSens graphs reduce the need for repeat viral load testing? S1 Dataset
BACKGROUND: In Zimbabwe, viral load (VL) testing for people living with HIV on antiretroviral therapy is performed at the National Microbiology Reference Laboratory using a NucliSens machine. Anecdotal evidence has shown that invalid graphs for “Target Not Detectable (TND)” will upon repeat VL testing produce a valid result for virus not detected, therefore removing the need to repeat the test. This needs formal assessment.
OBJECTIVES: To determine i) intra- and inter-rater agreement of the visual interpretation of NucliSens graphs (Target Detectable [TD], TND and No Line [NL]) between two laboratory scientists and ii) sensitivity, specificity and predictive values of the NucliSens graphs compared with repeat VL results.
METHOD: Cross sectional study using secondary data. Two laboratory scientists independently rated graphs one week apart for intra-rater agreement and compared final ratings with each other for inter-rater agreement. Consensus interpretations of graphs were compared with repeat VL results. Kappa coefficients were used to obtain measures of agreement.
RESULTS: There were 562 patients with NucliSens graphs and repeat VL. Kappa scores were: 0.98 (Scientist A); 0.99 (Scientist B); 0.96 (Scientist A versus Scientist B); and 0.65 (NucliSens graphs versus VL). Sensitivity, specificity, positive predictive value and negative predictive value for graphs compared with VL were 71%, 92%, 79% and 89% respectively.
CONCLUSION: Intra-and inter-rater agreements were almost perfect. The negative predictive value translates to a false negative rate of 11%. If repeat VL testing is not done, the clinical consequences need to be balanced against cost savings and the risks outweigh the benefits.
Keywords
Antiretroviral therapy, HIV, Viral load, Zimbabwe, NucliSens graphsItem Type | Dataset |
---|---|
Capture method | Experiment |
Date | 20 November 2019 |
Language(s) of written materials | English |
Creator(s) |
Handireketi, N, Timire, C |
LSHTM Faculty/Department | Faculty of Infectious and Tropical Diseases > Dept of Clinical Research |
Participating Institutions | London School of Hygiene & Tropical Medicine, London, United Kingdom |
Date Deposited | 22 Nov 2019 12:51 |
Last Modified | 26 Jun 2025 08:59 |
Publisher | PLOS ONE |
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- Data record – Figshare (Data)
- S1 Data download - Figshare (Online Data Resource)
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- Data record – Figshare (Data)
- S1 Data download - Figshare (Online Data Resource)
- S2 Data codebook - Figshare (Data)
- PLOS One (Paper)