دورية أكاديمية
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.
| العنوان: | 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. |
|---|---|
| المؤلفون: | Ndoye AS; Laboratoire Bactériologie-Virologie, Hopital Aristide Le Dantec, Dakar, Senegal.; Institute for Health Research, Epidemiological Surveillance and Training, Dakar, Senegal., Ndiaye HD; Laboratoire Bactériologie-Virologie, Hopital Aristide Le Dantec, Dakar, Senegal., Diallo M; Clinton Health Access Initiative, Dakar, Senegal., Diack A; Hopital d´Enfants Albert Royer, Dakar, Senegal., Coulibaly K; Division de Lutte Contre le SIDA/IST, Dakar, Senegal., Lo G; Laboratoire Bactériologie-Virologie, Hopital Aristide Le Dantec, Dakar, Senegal.; Institute for Health Research, Epidemiological Surveillance and Training, Dakar, Senegal., Kiernan B; Clinton Health Access Initiative, Dakar, Senegal., Sène PY; Laboratoire Bactériologie-Virologie, Hopital Aristide Le Dantec, Dakar, Senegal., Ndiaye O; Laboratoire Bactériologie-Virologie, Hopital Aristide Le Dantec, Dakar, Senegal.; Institute for Health Research, Epidemiological Surveillance and Training, Dakar, Senegal., Ngom NF; United Nations International Children's Emergency Fund (UNICEF), Dakar, Senegal., Fall M; Laboratoire Bactériologie-Virologie, Hopital Aristide Le Dantec, Dakar, Senegal., Diop K; Division de Lutte Contre le SIDA/IST, Dakar, Senegal., Gueye SB; Laboratoire Bactériologie-Virologie, Hopital Aristide Le Dantec, Dakar, Senegal., Dieng A; Laboratoire Bactériologie-Virologie, Hopital Aristide Le Dantec, Dakar, Senegal., Lejeune C; Clinton Health Access Initiative, Dakar, Senegal., Ndour CT; Division de Lutte Contre le SIDA/IST, Dakar, Senegal., Kane CT; Institute for Health Research, Epidemiological Surveillance and Training, Dakar, Senegal. |
| المصدر: | The Pan African medical journal [Pan Afr Med J] 2022 Sep 27; Vol. 43, pp. 42. Date of Electronic Publication: 2022 Sep 27 (Print Publication: 2022). |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: African Field Epidemiology Network Country of Publication: Uganda NLM ID: 101517926 Publication Model: eCollection Cited Medium: Internet ISSN: 1937-8688 (Electronic) NLM ISO Abbreviation: Pan Afr Med J Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Kampala, Uganda : African Field Epidemiology Network |
| مواضيع طبية MeSH: | HIV-1*/genetics , HIV Infections*, Infant ; Infant, Newborn ; Child ; Humans ; Female ; HIV-2 ; Potassium Iodide ; Point-of-Care Systems ; Senegal ; Infectious Disease Transmission, Vertical ; Sensitivity and Specificity ; Early Diagnosis ; Viral Load ; RNA, Viral |
| مستخلص: | 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® 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® 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® 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. Competing Interests: The authors declare no competing interests. (Copyright: Aissatou Sow Ndoye et al.) |
| References: | Lancet HIV. 2017 Oct;4(10):e442-e448. (PMID: 28711526) PLoS One. 2017 Dec 20;12(12):e0189226. (PMID: 29261707) Med Trop (Mars). 2002;62(6):634-6. (PMID: 12731313) J Virol Methods. 2016 Mar;229:35-9. (PMID: 26709099) J Virol Methods. 2016 Mar;229:12-5. (PMID: 26706730) J Acquir Immune Defic Syndr. 2017 Aug 15;75(5):e128-e131. (PMID: 28350554) PLoS One. 2016 Mar 31;11(3):e0152672. (PMID: 27032094) J Clin Microbiol. 2017 Nov;55(11):3227-3235. (PMID: 28855305) J Int AIDS Soc. 2015 Dec 02;18(Suppl 6):20299. (PMID: 26639120) AIDS. 2009 Jan 2;23(1):101-6. (PMID: 19065753) Open AIDS J. 2008;2:17-25. (PMID: 18923696) Pilot Feasibility Stud. 2019 Jan 25;5:18. (PMID: 30701079) J Clin Microbiol. 2014 Mar;52(3):773-80. (PMID: 24353004) J Acquir Immune Defic Syndr. 2014 Sep 1;67(1):e1-4. (PMID: 24933096) PLoS One. 2019 Mar 22;14(3):e0213865. (PMID: 30901343) PLoS One. 2018 Dec 27;13(12):e0209778. (PMID: 30589900) Pediatr Infect Dis J. 2005 Nov;24(11):993-7. (PMID: 16282936) |
| فهرسة مساهمة: | Keywords: HIV; early infant diagnosis; evaluation; infant; performance |
| المشرفين على المادة: | 1C4QK22F9J (Potassium Iodide) 0 (RNA, Viral) |
| تواريخ الأحداث: | Date Created: 20221216 Date Completed: 20221219 Latest Revision: 20221222 |
| رمز التحديث: | 20240628 |
| مُعرف محوري في PubMed: | PMC9733457 |
| DOI: | 10.11604/pamj.2022.43.42.32714 |
| PMID: | 36523274 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1937-8688 |
|---|---|
| DOI: | 10.11604/pamj.2022.43.42.32714 |