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External quality assessment of point-of-care CD4 testing in Thailand and Southeast Asia

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Abstract

In recent years, the use of point-of-care (POC) CD4 testing technologies has increased dramatically in Thailand and other Southeast Asian (SEA) countries. However, no data regarding external quality assessment of these POC CD4 testing technologies have been reported. The current study aimed to evaluate the performance of POC CD4 testing technologies, including BD FACSPresto, CyFlow, Guava, Muse, and PIMA, used in the participating laboratories in Thailand, Myanmar, Laos, Indonesia, and Nepal from 2014 to 2017. The results showed a trend toward an increasing number of participating laboratories using POC CD4 testing technologies between trial numbers 73 and 90. In the laboratories participating in the study, CyFlow technologies were the most used POC CD4 testing technologies. In addition, a trend of decreasing coefficients of variation (%CVs) was demonstrated across the trials, and the final trial showed an overall %CV of 14 %. In trial numbers 73 and 77, 57 % and 68 % of measurements showed standard deviation index (SDI) values ranging between − 1 and + 1. In trial numbers 80 and 90, the proportion of measurements with SDI values ranging between − 1 and + 1 had increased to 100 % and 72 %. These results suggest an improvement in POC CD4 testing in Thailand and other SEA countries.

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Abbreviations

POC:

Point of care

CV :

Coefficient of variation

SDI :

Standard deviation index

EQA:

External quality assessment

References

  1. El-Sadr WM, Lundgren J, Neaton JD, Gordin F, Abrams D, Arduino RC, Babiker A, Burman W, Clumeck N, Cohen CJ, Cohn D, Cooper D, Darbyshire J, Emery S, Fatkenheuer G, Gazzard B, Grund B, Hoy J, Klingman K, Losso M, Markowitz N, Neuhaus J, Phillips A, Rappoport C (2006) CD4+ count-guided interruption of antiretroviral treatment. N Engl J Med 355(22):2283–2296. https://doi.org/10.1056/NEJMoa062360

    Article  CAS  PubMed  Google Scholar 

  2. Lundgren JD, Babiker AG, Gordin F, Emery S, Grund B, Sharma S, Avihingsanon A, Cooper DA, Fatkenheuer G, Llibre JM, Molina JM, Munderi P, Schechter M, Wood R, Klingman KL, Collins S, Lane HC, Phillips AN, Neaton JD (2015) Initiation of antiretroviral therapy in early asymptomatic HIV infection. N Engl J Med 373(9):795–807. https://doi.org/10.1056/NEJMoa1506816

    Article  CAS  PubMed  Google Scholar 

  3. World Health Organization (2015) Guideline on when to start antiretroviral therapy and on pre-exposure prophylaxis for HIV. World Health Organization, Geneva

    Google Scholar 

  4. Diagbouga S, Chazallon C, Kazatchkine MD, Van de Perre P, Inwoley A, M’Boup S, David MP, Tenin AT, Soudre R, Aboulker JP, Weiss L (2003) Successful implementation of a low-cost method for enumerating CD4+ T lymphocytes in resource-limited settings: the ANRS 12-26 study. AIDS 17(15):2201–2208. https://doi.org/10.1097/01.aids.0000088198.77946.5e

    Article  PubMed  Google Scholar 

  5. Janossy G, Jani I, Gohde W (2000) Affordable CD4(+) T-cell counts on ‘single-platform’ flow cytometers I. Primary CD4 gating. Br J Haematol 111(4):1198–1208

    Article  CAS  PubMed  Google Scholar 

  6. Mandy F, Nicholson J, Autran B, Janossy G (2002) T-cell subset counting and the fight against AIDS: reflections over a 20-year struggle. Cytometry 50(2):39–45. https://doi.org/10.1002/cyto.10097

    Article  PubMed  Google Scholar 

  7. Faal M, Naidoo N, Glencross DK, Venter WD, Osih R (2011) Providing immediate CD4 count results at HIV testing improves ART initiation. J Acquir Immune Defic Syndr 58(3):e54–e59. https://doi.org/10.1097/QAI.0b013e3182303921

    Article  PubMed  Google Scholar 

  8. Jani IV, Sitoe NE, Alfai ER, Chongo PL, Quevedo JI, Rocha BM, Lehe JD, Peter TF (2011) Effect of point-of-care CD4 cell count tests on retention of patients and rates of antiretroviral therapy initiation in primary health clinics: an observational cohort study. Lancet 378(9802):1572–1579. https://doi.org/10.1016/s0140-6736(11)61052-0

    Article  PubMed  Google Scholar 

  9. Mnyani CN, McIntyre JA, Myer L (2012) The reliability of point-of-care CD4 testing in identifying HIV-infected pregnant women eligible for antiretroviral therapy. J Acquir Immune Defic Syndr 60(3):260–264. https://doi.org/10.1097/QAI.0b013e318256b651

    Article  CAS  PubMed  Google Scholar 

  10. Malagun M, Nano G, Chevallier C, Opina R, Sawiya G, Kivavia J, Kalinoe A, Nathaniel K, Kaminiel O, Millan J, Carmone A, Dini M, Palou T, Topma K, Lavu E, Markby J (2014) Multisite evaluation of point of care CD4 testing in Papua New Guinea. PLoS ONE 9(11):e112173. https://doi.org/10.1371/journal.pone.0112173

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  11. Heffernan A, Barber E, Thomas R, Fraser C, Pickles M, Cori A (2016) Impact and cost-effectiveness of point-of-care CD4 testing on the HIV epidemic in South Africa. PLoS ONE 11(7):e0158303. https://doi.org/10.1371/journal.pone.0158303

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  12. Coetzee LM, Moodley K, Glencross DK (2016) Performance evaluation of the Becton Dickinson FACSPresto near-patient CD4 instrument in a laboratory and typical field clinic setting in South Africa. PLoS ONE 11(5):e0156266. https://doi.org/10.1371/journal.pone.0156266

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  13. Fryland M, Chaillet P, Zachariah R, Barnaba A, Bonte L, Andereassen R, Charrondiere S, Teck R, Didakus O (2006) The Partec CyFlow counter could provide an option for CD4+ T-cell monitoring in the context of scaling-up antiretroviral treatment at the district level in Malawi. Trans R Soc Trop Med Hyg 100(10):980–985. https://doi.org/10.1016/j.trstmh.2005.11.014

    Article  CAS  PubMed  Google Scholar 

  14. Mossoro-Kpinde CD, Kouabosso A, Mboumba Bouassa RS, Longo JD, Kokanzo E, Feissona R, Gresenguet G, Belec L (2016) Performance evaluation of the touchscreen-based Muse Auto CD4/CD4% single-platform system for CD4 T cell numeration in absolute number and in percentage using blood samples from children and adult patients living in the Central African Republic. J Transl Med 14(1):326. https://doi.org/10.1186/s12967-016-1082-7

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  15. Thakar M, Mahajan B, Shaikh N, Bagwan S, Sane S, Kabra S, Rewari B, Shaukat M, Singh N, Trevor P, Paranjape R (2012) Utility of the point of care CD4 analyzer, PIMA, to enumerate CD4 counts in the field settings in India. AIDS Res Ther 9(1):26. https://doi.org/10.1186/1742-6405-9-26

    Article  PubMed  PubMed Central  Google Scholar 

  16. Sachithanandham J, Solomon K, Prasannakumar S, Nithyandham G, Kannangai R (2011) Evaluation of a dry format reagent for CD4+ and CD8+ T-cell enumeration with FACSCount and Guava PCA [corrected]. Indian J Med Microbiol 29(4):401–405. https://doi.org/10.4103/0255-0857.90176

    Article  CAS  PubMed  Google Scholar 

  17. Meyers AFA, Sandstrom P, Denny TN, Hurlston M, Ball TB, Peeling RW, Boeras DI (2016) Quality assurance for HIV point-of-care testing and treatment monitoring assays. Afr J Lab Med 5(2):557. https://doi.org/10.4102/ajlm.v5i2.557

    Article  PubMed  PubMed Central  Google Scholar 

  18. Pham MD, Agius PA, Romero L, McGlynn P, Anderson D, Crowe SM, Luchters S (2016) Acceptability and feasibility of point-of-care CD4 testing on HIV continuum of care in low and middle income countries: a systematic review. BMC Health Serv Res 16(a):343. https://doi.org/10.1186/s12913-016-1588-y

    Article  PubMed  PubMed Central  Google Scholar 

  19. Westerman LE, Kohatsu L, Ortiz A, McClain B, Kaplan J, Spira T, Marston B, Jani IV, Nkengasong J, Parsons LM (2010) A quality management systems approach for CD4 testing in resource-poor settings. Am J Clin Pathol 134(4):556–567. https://doi.org/10.1309/ajcpp7mchfylx2fm

    Article  PubMed  Google Scholar 

  20. Noulsri E, Pattanapanyasat K (2015) Guidelines for organizing national external quality assessment scheme for performing CD4+ T-lymphocyte determinations in persons infected with HIV in resource-limited settings. Accred Qual Assur 20(6):511–518. https://doi.org/10.1007/s00769-015-1151-2

    Article  Google Scholar 

  21. Noulsri E, Lerdwana S, Pattanapanyasat K (2016) Long-term external quality assessment program for CD4+ T-lymphocyte enumeration in Thailand. Accred Qual Assur 21(5):367–375. https://doi.org/10.1007/s00769-016-1225-9

    Article  CAS  Google Scholar 

  22. Glencross DK, Aggett HM, Stevens WS, Mandy F (2008) African regional external quality assessment for CD4 T-cell enumeration: development, outcomes, and performance of laboratories. Cytom Part B Clin Cytom 74(Suppl 1):S69–S79. https://doi.org/10.1002/cyto.b.20397

    Article  Google Scholar 

  23. Mwau M, Adungo F, Kadima S, Njagi E, Kirwaye C, Abubakr NS, Okubi LA, Waihenya M, Lusike J, Hungu J (2013) Evaluation of PIMA(R) point of care technology for CD4 T cell enumeration in Kenya. PLoS ONE 8(6):e67612. https://doi.org/10.1371/journal.pone.0067612

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  24. Diaw PA, Daneau G, Coly AA, Ndiaye BP, Wade D, Camara M, Mboup S, Kestens L, Dieye TN (2011) Multisite evaluation of a point-of-care instrument for CD4(+) T-cell enumeration using venous and finger-prick blood: the PIMA CD4. J Acquir Immune Defic Syndr 58(4):e103–e111. https://doi.org/10.1097/QAI.0b013e318235b378

    Article  PubMed  Google Scholar 

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Acknowledgements

This research project is supported by the Faculty of Medicine Siriraj Hospital, Mahidol University; National Health Security Office; Thailand Ministry of Public Health; and WHO South-East Asia Region. KP was the recipient of the Thailand Research Fund—Distinguished Research Professor Award (Grant Contact Number DPG5980001).

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Correspondence to Egarit Noulsri or Kovit Pattanapanyasat.

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Noulsri, E., Lerdwana, S. & Pattanapanyasat, K. External quality assessment of point-of-care CD4 testing in Thailand and Southeast Asia. Accred Qual Assur 24, 145–150 (2019). https://doi.org/10.1007/s00769-018-1358-0

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