Can visual interpretation of NucliSens graphs reduce the need for repeat viral load testing?


Autoři: Newten Handireketi aff001;  Collins Timire aff002;  Hemant Deepak Shewade aff004;  Ellen Munemo aff002;  Charles Nyagupe aff002;  Sandra Chipuka aff002;  Lucia Sisya aff002;  Hlanai Gumbo aff002;  Ezekiel Dhitima aff002;  Anthony D. Harries aff004
Působiště autorů: Ministry of Health and Child Care Zimbabwe, National Institute of Health Research (NIHR), Harare, Zimbabwe aff001;  Ministry of Health and Child Care Zimbabwe, National HIV/AIDS and TB Programme, Harare, Zimbabwe aff002;  International Union Against Tuberculosis and Lung Disease, Harare, Zimbabwe aff003;  International Union Against Tuberculosis and Lung Disease, New Dehli, India aff004;  International Union Against Tuberculosis and Lung Disease, Paris, France aff005;  London School of Hygiene and Tropical Medicine, London, United Kingdom aff006
Vyšlo v časopise: PLoS ONE 14(11)
Kategorie: Research Article
doi: 10.1371/journal.pone.0223597

Souhrn

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.

Klíčová slova:

Antimicrobial resistance – Government laboratories – Graphs – Scientists – Target detection – Viral load – Zimbabwe


Zdroje

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PLOS One


2019 Číslo 11