#PAGE_PARAMS# #ADS_HEAD_SCRIPTS# #MICRODATA#

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
prolekare.web.journal.doi_sk: https://doi.org/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:

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


Zdroje

1. World Health Organization. WHO HIV Update. July 2018.

2. Columbia University. Zimbabwe Population-based HIV Impact Assessment (ZIMPHIA) 2015–2016. Available at: http://phia.icap.columbia.edu/wp-content/uploads/2016/11/ZIMBABWE-Factsheet.FIN_.pdf (accessed 18 April 2018)

3. World Health Organization. Scaling up antiretroviral therapy in resource-limited settings: Guidelines for a public health approach. 2003 revision. WHO, Geneva, Switzerland.

4. Harries AD, Zachariah R, van Oosterhout JJ, Reid SD, Hosseinipour MC, Arendt V et al. Diagnosis and management of antiretroviral-therapy failure in resource-limited settings in sub-Saharan Africa: challenges and perspectives. Lancet Infect Dis 2010; 10: 60–65. doi: 10.1016/S1473-3099(09)70321-4 20129150

5. World Health Organization. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. Recommendations for a public health approach. June 2013. WHO, Geneva, Switzerland.

6. World Health Organization. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. Recommendations for a public health approach. Second Edition. 2016. WHO, Geneva, Switzerland.

7. UNAIDS 90-90-90. An ambitious treatment target to help end the AIDS epidemic. 2014. UNAIDS, Geneva, Switzerland.

8. ZIMSTATS and Macro ICF Inc. Zimbabwe Population Census 2012. Available: http://www.zimstat.co.zw/sites/default/files/img/National_Report.pdf [accessed 18 April 2018)

9. The World Bank. GDP per capita (current USD$). Available: http://data.worldbank.org/indicator/NY.GDP.PCAP.CD [accessed 18 April 2018)

10. National Microbiology Reference Laboratory Handbook. Version 2017. Ministry of Health and Child Care, Zimbabwe.

11. Standard Operating Procedure 300P07. National Microbiology Reference Laboratory Handbook. Version 2017. Ministry of Health and Child Care, Zimbabwe.

12. Viera AJ, Garrett JM. Understanding interobserver agreement: the kappa statistic. Fam Med 2005; 37: 360–363. 15883903

13. Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, et al for the HPTN 052 Study Team. Prevention of HIV-1 infection with early antiretroviral therapy. NEngl J Med 2011; 365: 493–505.

14. Hammer SM. Antiretroviral treatment as prevention. N Engl J Med 2011; 365: 561–562. doi: 10.1056/NEJMe1107487 21767102

15. Quinn TC, Wawer MJ, Sewankambo N, Serwadda D, Li C, Wabwire-Mangen F et al. Viral load and heterosexual transmission of human immunodeficiency virus type 1. N Engl J Med 2000; 342: 921–929. doi: 10.1056/NEJM200003303421303 10738050

16. Beyrer C, Pozniak A. HIV drug resistance–an emerging threat. N Engl J Med 2017; 377: 1605–1607. doi: 10.1056/NEJMp1710608 29069566

17. Gupta RK, Gregson J, Parkin N, Haile-Selassie H, Tanuri A, Andrade Forero L et al. HIV- drug resistance before initiation or re-initiation of first-line antiretroviral therapy in low-income and middle-income countries: a systematic review and meta-regression analysis. Lancet Infect Dis 2018; 18: 346–355. doi: 10.1016/S1473-3099(17)30702-8 29198909


Článok vyšiel v časopise

PLOS One


2019 Číslo 11
Najčítanejšie tento týždeň
Najčítanejšie v tomto čísle
Kurzy

Zvýšte si kvalifikáciu online z pohodlia domova

Aktuální možnosti diagnostiky a léčby litiáz
nový kurz
Autori: MUDr. Tomáš Ürge, PhD.

Všetky kurzy
Prihlásenie
Zabudnuté heslo

Zadajte e-mailovú adresu, s ktorou ste vytvárali účet. Budú Vám na ňu zasielané informácie k nastaveniu nového hesla.

Prihlásenie

Nemáte účet?  Registrujte sa

#ADS_BOTTOM_SCRIPTS#