PMID- 36523274 OWN - NLM STAT- MEDLINE DCOM- 20221219 LR - 20221222 IS - 1937-8688 (Electronic) VI - 43 DP - 2022 TI - Validation of the point-of-care (POC) technologies Xpert HIV-1 Qual and m-PIMA HIV 1/2 detect for early diagnosis of HIV-1 and HIV-2 in Senegal. PG - 42 LID - 10.11604/pamj.2022.43.42.32714 [doi] LID - 42 AB - INTRODUCTION: early infant diagnosis (EID) is crucial in the prevention of mother to child transmission (PMTCT) of human immunodeficiency virus (HIV) and is an essential component for the elimination of HIV. EID can be strengthened in resource-limited countries by the introduction and the roll out of real-time polymerase chain reaction (PCR) technologies via point-of-care (POC) devices which improves treatment in remote areas and reduces turnaround time for clinicians and patients to receive results and linkage to care. The objective of this study was to evaluate the performance of Xpert(R) HIV-1 Qual Assay (Cepheid) and m-PIMA HIV 1/2 Detect (ABBOTT) for EID of HIV-1 and HIV-2. METHODS: the performance of the Xpert(R) HIV-1 qual device was evaluated with 192 samples including 100 dried blood spot (DBS) samples from the National Reference Laboratory biobank (71 negative and 29 positive samples) and an additional 92 whole blood samples collected from infants from neonatal departments. These infants from seven treatment centers in the Dakar region were born to mothers infected with HIV-1 (n=91), HIV-2 (n= 8) or HIV-1/2 (n=1). The m-PIMA HIV 1/2 detect assay was evaluated on whole blood samples (n=100) with 92 HIV-1 samples and 8 HIV-2 samples from children born to HIV-infected mothers. The Cobas AmpliPreP/Cobas TaqMan (CAP/CTM) platform from Roche Diagnostic Laboratories was used as a reference for HIV-1 diagnosis and the Generic HIV-2 Viral Load Assay (Biocentric) was used as a reference for HIV-2 diagnosis. Performance was evaluated by calculating sensitivity (Se), specificity (Sp), positive predictive value (PPV), negative predictive value (NPV) and Cohen's kappa coefficient. RESULTS: for HIV-1 detection on GeneXpert and m-PIMA, no discordance was found on the samples tested, i.e. a sensitivity of 100% (95% CI: 93.9-100%), a specificity of 100% (95% CI: 97.5-100%), a positive predictive value (PPV) of 100% (95% CI: 93.9-100%) and a negative predictive value (NPV) of 100% (95% CI: 97.5-100%). Agreement with Cobas AmpliPrep/Cobas TaqMan (CAP/CTM) was 100% with a Kappa coefficient of 1 (p<0.001, 95% CI) for both techniques. Similarly, the comparison between m-PIMA and generic biocentric for the detection of HIV-2 on the 8 samples tested showed perfect agreement. CONCLUSION: these results confirm the excellent performance of the Xpert(R) HIV-1 qual and m-PIMA HIV1/2 detect tests for the detection of HIV-1 and HIV-2 and encourage the extension of POC tests to improve access to EID in Senegal. CI - Copyright: Aissatou Sow Ndoye et al. FAU - Ndoye, Aissatou Sow AU - Ndoye AS AD - Laboratoire Bacteriologie-Virologie, Hopital Aristide Le Dantec, Dakar, Senegal. AD - Institute for Health Research, Epidemiological Surveillance and Training, Dakar, Senegal. FAU - Ndiaye, Halimatou Diop AU - Ndiaye HD AD - Laboratoire Bacteriologie-Virologie, Hopital Aristide Le Dantec, Dakar, Senegal. FAU - Diallo, Marieme AU - Diallo M AD - Clinton Health Access Initiative, Dakar, Senegal. FAU - Diack, Aminata AU - Diack A AD - Hopital d Enfants Albert Royer, Dakar, Senegal. FAU - Coulibaly, Khadydiatou AU - Coulibaly K AD - Division de Lutte Contre le SIDA/IST, Dakar, Senegal. FAU - Lo, Gora AU - Lo G AD - Laboratoire Bacteriologie-Virologie, Hopital Aristide Le Dantec, Dakar, Senegal. AD - Institute for Health Research, Epidemiological Surveillance and Training, Dakar, Senegal. FAU - Kiernan, Brianan AU - Kiernan B AD - Clinton Health Access Initiative, Dakar, Senegal. FAU - Sene, Pauline Yacine AU - Sene PY AD - Laboratoire Bacteriologie-Virologie, Hopital Aristide Le Dantec, Dakar, Senegal. FAU - Ndiaye, Ousseynou AU - Ndiaye O AD - Laboratoire Bacteriologie-Virologie, Hopital Aristide Le Dantec, Dakar, Senegal. AD - Institute for Health Research, Epidemiological Surveillance and Training, Dakar, Senegal. FAU - Ngom, Ndeye Fatou AU - Ngom NF AD - United Nations International Children's Emergency Fund (UNICEF), Dakar, Senegal. FAU - Fall, Mengue AU - Fall M AD - Laboratoire Bacteriologie-Virologie, Hopital Aristide Le Dantec, Dakar, Senegal. FAU - Diop, Karim AU - Diop K AD - Division de Lutte Contre le SIDA/IST, Dakar, Senegal. FAU - Gueye, Sokhna Bousso AU - Gueye SB AD - Laboratoire Bacteriologie-Virologie, Hopital Aristide Le Dantec, Dakar, Senegal. FAU - Dieng, Assane AU - Dieng A AD - Laboratoire Bacteriologie-Virologie, Hopital Aristide Le Dantec, Dakar, Senegal. FAU - Lejeune, Charlotte AU - Lejeune C AD - Clinton Health Access Initiative, Dakar, Senegal. FAU - Ndour, Cheikh Tidiane AU - Ndour CT AD - Division de Lutte Contre le SIDA/IST, Dakar, Senegal. FAU - Kane, Coumba Toure AU - Kane CT AD - Institute for Health Research, Epidemiological Surveillance and Training, Dakar, Senegal. LA - eng PT - Journal Article DEP - 20220927 PL - Uganda TA - Pan Afr Med J JT - The Pan African medical journal JID - 101517926 RN - 1C4QK22F9J (Potassium Iodide) RN - 0 (RNA, Viral) SB - IM MH - Infant MH - Infant, Newborn MH - Child MH - Humans MH - Female MH - *HIV-1/genetics MH - HIV-2 MH - Potassium Iodide MH - Point-of-Care Systems MH - Senegal MH - *HIV Infections MH - Infectious Disease Transmission, Vertical MH - Sensitivity and Specificity MH - Early Diagnosis MH - Viral Load MH - RNA, Viral PMC - PMC9733457 OTO - NOTNLM OT - HIV OT - early infant diagnosis OT - evaluation OT - infant OT - performance COIS- The authors declare no competing interests. EDAT- 2022/12/17 06:00 MHDA- 2022/12/20 06:00 PMCR- 2022/09/27 CRDT- 2022/12/16 02:13 PHST- 2021/12/06 00:00 [received] PHST- 2022/09/11 00:00 [accepted] PHST- 2022/12/16 02:13 [entrez] PHST- 2022/12/17 06:00 [pubmed] PHST- 2022/12/20 06:00 [medline] PHST- 2022/09/27 00:00 [pmc-release] AID - PAMJ-43-42 [pii] AID - 10.11604/pamj.2022.43.42.32714 [doi] PST - epublish SO - Pan Afr Med J. 2022 Sep 27;43:42. doi: 10.11604/pamj.2022.43.42.32714. eCollection 2022.