Heliyon (May 2024)
Performance characteristics of INDICAID antigen rapid diagnostic test on SARS-CoV-2 samples during the omicron wave in Cameroon
- Joseph Fokam,
- Désiré Takou,
- Ezechiel Ngoufack Jagni Semengue,
- Evariste Molimbou,
- Collins Chenwi Ambe,
- Alex Durand Nka,
- Sandrine Djupsa Ndjeyep,
- Grace Angong Beloumou,
- Christelle Aude Ka'e,
- Davy-Hyacinthe Gouissi Anguechia,
- Audrey Rachel Mundo Nayang,
- Larissa Gaëlle Moko Fotso,
- Aurelie Minelle Kengni Ngueko,
- Naomi-Karell Etame,
- Pamela Patricia Tueguem,
- Carlos Michel Tommo Tchouaket,
- Nadine Fainguem,
- Cyrille Abega Abega,
- Aissatou Abba,
- Derrick Tambe Ayuk Ngwese,
- Rina Djubgang Djoukwe,
- Blaise Akenji,
- Marie-Claire Okomo Assoumou,
- Nadia Mandeng,
- Linda Esso,
- Giulia Cappelli,
- Judith Shang,
- Clement Ndongmo,
- Georges Alain Etoundi Mballa,
- Nicaise Ndembi,
- Vittorio Colizzi,
- Carlo-Federico Perno,
- Alexis Ndjolo
Affiliations
- Joseph Fokam
- Chantal BIYA International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaoundé, Cameroon; Faculty of Health Sciences, University of Buea, Buea, Cameroon; National Public Health Emergency Operations Coordination Centre, Ministry of Public Health, Yaoundé, Cameroon; Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon; Corresponding author. Chantal BIYA International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaoundé, Cameroon.
- Désiré Takou
- Chantal BIYA International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaoundé, Cameroon
- Ezechiel Ngoufack Jagni Semengue
- Chantal BIYA International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaoundé, Cameroon
- Evariste Molimbou
- Chantal BIYA International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaoundé, Cameroon; Department of Experimental Medicine, Faculty of Medicine and Surgery, University of Rome “Tor Vergata”, Rome, Italy; Faculty of Science and Technology, Evangelic University of Cameroon, Bandjoun, Cameroon
- Collins Chenwi Ambe
- Chantal BIYA International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaoundé, Cameroon; Department of Experimental Medicine, Faculty of Medicine and Surgery, University of Rome “Tor Vergata”, Rome, Italy
- Alex Durand Nka
- Chantal BIYA International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaoundé, Cameroon
- Sandrine Djupsa Ndjeyep
- Chantal BIYA International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaoundé, Cameroon
- Grace Angong Beloumou
- Chantal BIYA International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaoundé, Cameroon
- Christelle Aude Ka'e
- Chantal BIYA International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaoundé, Cameroon; Department of Experimental Medicine, Faculty of Medicine and Surgery, University of Rome “Tor Vergata”, Rome, Italy
- Davy-Hyacinthe Gouissi Anguechia
- Chantal BIYA International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaoundé, Cameroon; Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon
- Audrey Rachel Mundo Nayang
- Chantal BIYA International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaoundé, Cameroon
- Larissa Gaëlle Moko Fotso
- Chantal BIYA International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaoundé, Cameroon; Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon
- Aurelie Minelle Kengni Ngueko
- Chantal BIYA International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaoundé, Cameroon; Department of Experimental Medicine, Faculty of Medicine and Surgery, University of Rome “Tor Vergata”, Rome, Italy
- Naomi-Karell Etame
- Chantal BIYA International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaoundé, Cameroon; Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon
- Pamela Patricia Tueguem
- Chantal BIYA International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaoundé, Cameroon
- Carlos Michel Tommo Tchouaket
- Chantal BIYA International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaoundé, Cameroon; School of Health Sciences, Catholic University of Central Africa, Yaoundé, Cameroon
- Nadine Fainguem
- Chantal BIYA International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaoundé, Cameroon
- Cyrille Abega Abega
- Chantal BIYA International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaoundé, Cameroon
- Aissatou Abba
- Chantal BIYA International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaoundé, Cameroon; Laboratory Department, Garoua Regional Health Centre, Garoua, Cameroon
- Derrick Tambe Ayuk Ngwese
- Chantal BIYA International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaoundé, Cameroon; Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon
- Rina Djubgang Djoukwe
- Directorate for Pharmacy, Drug and Laboratory, Ministry of Public Health, Yaounde, Cameroon
- Blaise Akenji
- National Public Health Laboratory, Yaoundé, Cameroon
- Marie-Claire Okomo Assoumou
- Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon; National Public Health Laboratory, Yaoundé, Cameroon
- Nadia Mandeng
- National Public Health Emergency Operations Coordination Centre, Ministry of Public Health, Yaoundé, Cameroon; Faculty of Health Sciences, University of Bamenda, Bamenda, Cameroon; Department of Disease, Epidemic and Pandemic Control, Ministry of Public Health, Yaounde, Cameroon
- Linda Esso
- National Public Health Emergency Operations Coordination Centre, Ministry of Public Health, Yaoundé, Cameroon; Department of Disease, Epidemic and Pandemic Control, Ministry of Public Health, Yaounde, Cameroon
- Giulia Cappelli
- Chantal BIYA International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaoundé, Cameroon; National Research Council, Rome, Italy
- Judith Shang
- United States Centres for Disease Control and Prevention, Country Office, Yaoundé, Cameroon
- Clement Ndongmo
- United States Centres for Disease Control and Prevention, Country Office, Yaoundé, Cameroon
- Georges Alain Etoundi Mballa
- National Public Health Emergency Operations Coordination Centre, Ministry of Public Health, Yaoundé, Cameroon; Department of Disease, Epidemic and Pandemic Control, Ministry of Public Health, Yaounde, Cameroon
- Nicaise Ndembi
- Africa Centres for Disease Control and Prevention (Africa CDC), Addis Ababa, Ethiopia
- Vittorio Colizzi
- Chantal BIYA International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaoundé, Cameroon; Department of Experimental Medicine, Faculty of Medicine and Surgery, University of Rome “Tor Vergata”, Rome, Italy; Faculty of Science and Technology, Evangelic University of Cameroon, Bandjoun, Cameroon
- Carlo-Federico Perno
- Bambino Gesu' Children's Research Hospital, Rome, Italy
- Alexis Ndjolo
- Chantal BIYA International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaoundé, Cameroon; Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon
- Journal volume & issue
-
Vol. 10,
no. 9
p. e29937
Abstract
Background: WHO recommends the use of COVID-19 antigen rapid diagnostic tests (Ag-RDT) with at least 80 % sensitivity and 97 % specificity. In the era of Omicron variants, we sought to ascertain the performance of the INDICAID™ Ag-RDT compared to real-time PCR (RT-PCR) as the gold standard. Methods: A laboratory-based study was conducted among consenting individuals tested for COVID-19 at the virology laboratory of the Chantal BIYA International Reference Centre, Yaoundé-Cameron. The samples were processed by INDICAID™ Ag-RDT and DaAn Gene real-time PCR according to the manufacturer's instructions, and PCR-results were interpreted as per cycle thresholds (CT). The sensitivity, specificity, positive and negative predictive values (PPV and NVP) of INDICAID™ Ag-RDT were evaluated according to PCR CT-values. Results: A total of 565 nasopharyngeal swabs were collected from participants (median age [IQR]: 40 [31–75]; M/F sex-ratio was 1.2 and 380 were vaccinated). Following PCR, overall COVID-19 positivity was 5.66 %. For CT < 37, INDICAID™ Ag-RDT sensitivity was 21.9 % (95%CI: [8.3–39.9]), specificity 100 % (95%CI: [99.3–100]); PPV 100 % (95%CI: [59.0–100]), NPV 95.5 % (95%CI: [93.4–97.1]) and kappa = 0.34 (95%CI: [0.19–0.35]). For CT < 25, sensitivity was 100 % (95%CI: [47.8–100.0]), specificity 99.6 % (95%CI: [98.7–99.9]); PPV 94.4 % (95%CI: [51.7–100]), NPV 100 % (95%CI: [99.3–100]) and kappa = 0.83 (95%CI: [0.6–1.0]). COVID-19 sequences generated were all Omicron BA.1 subvariants. Conclusion: For patients infected with high viral loads (CT < 25), INDICAID™ Ag-RDT has high intrinsic (sensitivity and specificity) and extrinsic (predictive values) performances for COVID-19 diagnosis. Due to its simplicity and short turnaround time, INDICAID™ Ag-RDT is, therefore a reliable tool to prevent the spread of COVID-19 at community level in the current era of Omicron subvariants.
