Performance characteristics of INDICAID antigen rapid diagnostic test on SARS-CoV-2 samples during the omicron wave in Cameroon

doi:10.1016/j.heliyon.2024.e29937

. 2024 Apr 19;10(9):e29937.

doi: 10.1016/j.heliyon.2024.e29937. eCollection 2024 May 15.

Performance characteristics of INDICAID antigen rapid diagnostic test on SARS-CoV-2 samples during the omicron wave in Cameroon

Joseph Fokam^{1

2

3

4}, Désiré Takou¹, Ezechiel Ngoufack Jagni Semengue¹, Evariste Molimbou^{1

5

6}, Collins Chenwi Ambe^{1

5}, Alex Durand Nka¹, Sandrine Djupsa Ndjeyep¹, Grace Angong Beloumou¹, Christelle Aude Ka'e^{1

5}, Davy-Hyacinthe Gouissi Anguechia^{1

4}, Audrey Rachel Mundo Nayang¹, Larissa Gaëlle Moko Fotso^{1

4}, Aurelie Minelle Kengni Ngueko^{1

5}, Naomi-Karell Etame^{1

4}, Pamela Patricia Tueguem¹, Carlos Michel Tommo Tchouaket^{1

7}, Nadine Fainguem¹, Cyrille Abega Abega¹, Aissatou Abba^{1

8}, Derrick Tambe Ayuk Ngwese^{1

4}, Rina Djubgang Djoukwe⁹, Blaise Akenji¹⁰, Marie-Claire Okomo Assoumou^{4

10}, Nadia Mandeng^{3

11

12}, Linda Esso^{3

12}, Giulia Cappelli^{1

13}, Judith Shang¹⁴, Clement Ndongmo¹⁴, Georges Alain Etoundi Mballa^{3

12}, Nicaise Ndembi¹⁵, Vittorio Colizzi^{1

5

6}, Carlo-Federico Perno¹⁶, Alexis Ndjolo^{1

4}

Affiliations

¹ Chantal BIYA International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaoundé, Cameroon.
² Faculty of Health Sciences, University of Buea, Buea, Cameroon.
³ National Public Health Emergency Operations Coordination Centre, Ministry of Public Health, Yaoundé, Cameroon.
⁴ Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon.
⁵ Department of Experimental Medicine, Faculty of Medicine and Surgery, University of Rome "Tor Vergata", Rome, Italy.
⁶ Faculty of Science and Technology, Evangelic University of Cameroon, Bandjoun, Cameroon.
⁷ School of Health Sciences, Catholic University of Central Africa, Yaoundé, Cameroon.
⁸ Laboratory Department, Garoua Regional Health Centre, Garoua, Cameroon.
⁹ Directorate for Pharmacy, Drug and Laboratory, Ministry of Public Health, Yaounde, Cameroon.
¹⁰ National Public Health Laboratory, Yaoundé, Cameroon.
¹¹ Faculty of Health Sciences, University of Bamenda, Bamenda, Cameroon.
¹² Department of Disease, Epidemic and Pandemic Control, Ministry of Public Health, Yaounde, Cameroon.
¹³ National Research Council, Rome, Italy.
¹⁴ United States Centres for Disease Control and Prevention, Country Office, Yaoundé, Cameroon.
¹⁵ Africa Centres for Disease Control and Prevention (Africa CDC), Addis Ababa, Ethiopia.
¹⁶ Bambino Gesu' Children's Research Hospital, Rome, Italy.

PMID: 38694118
PMCID: PMC11058880
DOI: 10.1016/j.heliyon.2024.e29937

Performance characteristics of INDICAID antigen rapid diagnostic test on SARS-CoV-2 samples during the omicron wave in Cameroon

Joseph Fokam et al. Heliyon. 2024.

. 2024 Apr 19;10(9):e29937.

doi: 10.1016/j.heliyon.2024.e29937. eCollection 2024 May 15.

Authors

Affiliations

¹ Chantal BIYA International Reference Centre for Research on HIV/AIDS Prevention and Management, Yaoundé, Cameroon.
² Faculty of Health Sciences, University of Buea, Buea, Cameroon.
³ National Public Health Emergency Operations Coordination Centre, Ministry of Public Health, Yaoundé, Cameroon.
⁴ Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon.
⁵ Department of Experimental Medicine, Faculty of Medicine and Surgery, University of Rome "Tor Vergata", Rome, Italy.
⁶ Faculty of Science and Technology, Evangelic University of Cameroon, Bandjoun, Cameroon.
⁷ School of Health Sciences, Catholic University of Central Africa, Yaoundé, Cameroon.
⁸ Laboratory Department, Garoua Regional Health Centre, Garoua, Cameroon.
⁹ Directorate for Pharmacy, Drug and Laboratory, Ministry of Public Health, Yaounde, Cameroon.
¹⁰ National Public Health Laboratory, Yaoundé, Cameroon.
¹¹ Faculty of Health Sciences, University of Bamenda, Bamenda, Cameroon.
¹² Department of Disease, Epidemic and Pandemic Control, Ministry of Public Health, Yaounde, Cameroon.
¹³ National Research Council, Rome, Italy.
¹⁴ United States Centres for Disease Control and Prevention, Country Office, Yaoundé, Cameroon.
¹⁵ Africa Centres for Disease Control and Prevention (Africa CDC), Addis Ababa, Ethiopia.
¹⁶ Bambino Gesu' Children's Research Hospital, Rome, Italy.

PMID: 38694118
PMCID: PMC11058880
DOI: 10.1016/j.heliyon.2024.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.

Keywords: Antigen detection; Cameroon; Diagnostic performance; INDICAID™ Ag-RDT; SARS‐CoV‐2.

PubMed Disclaimer

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Cited by

Viral dynamics and factors associated with duration of COVID-19 positivity: evidence from the first-three epidemiological waves in Cameroon.
Fokam J, Kengni Ngueko AM, Nka AD, Chenwi CA, Ngoufack Jagni Semengue E, Bouba Y, Takou D, Fainguem N, Tommo Tchouaket MC, Ka'e AC, Beloumou GA, Djupsa Ndjeyep SC, Togna Pabo WL, Gouissi Anguechia DH, Etame NK, Molimbou E, Nayang Mundo RA, Abba A, Sosso SM, Otshudiema Otokoye J, Ngongang Ouankou C, Alteri C, Colagrossi L, Santoro MM, Ceccherini-Silberstein F, Boum Y 2nd, Halle Ekane EG, Njamnshi AK, Colizzi V, Ndembi N, Ndjolo A, Perno CF. Fokam J, et al. BMC Infect Dis. 2025 May 5;25(1):660. doi: 10.1186/s12879-025-11048-5. BMC Infect Dis. 2025. PMID: 40325359 Free PMC article.

References

1. Chowdhury S.D., Oommen A.M. Epidemiology of COVID-19. J. Dig. Endosc. 2020;11:3. doi: 10.1055/S-0040-1712187. - DOI
1. Wu Z., McGoogan J.M. Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China: summary of a report of 72314 cases from the Chinese center for disease control and prevention. JAMA, J. Am. Med. Assoc. 2020;323:1239–1242. doi: 10.1001/JAMA.2020.2648. - DOI - PubMed
1. Yan R., Zhang Y., Li Y., Xia L., Guo Y., Zhou Q. Structural basis for the recognition of SARS-CoV-2 by full-length human ACE2. Science. 2020;367:1444–1448. doi: 10.1126/science.abb2762. - DOI - PMC - PubMed
1. Zhu N., Zhang D., Wang W., Li X., Yang B., Song J., Zhao X., Huang B., Shi W., Lu R., Niu P., Zhan F., Ma X., Wang D., Xu W., Wu G., Gao G.F., Tan W. A novel coronavirus from patients with pneumonia in China, 2019. N. Engl. J. Med. 2020;382:727–733. doi: 10.1056/NEJMOA2001017/SUPPL_FILE/NEJMOA2001017_DISCLOSURES.PDF. - DOI - PMC - PubMed
1. World Health Organization (WHO), n.d. WHO Coronavirus (COVID-19) Dashboard | WHO Coronavirus (COVID-19) Dashboard With Vaccination Data [WWW Document]. URL https://covid19.who.int/?adgroupsurvey=%7Badgroupsurvey%7D&gclid=Cj0KCQi... (accessed 8.7.23)..

LinkOut - more resources

Full Text Sources
Miscellaneous
- NCI CPTAC Assay Portal

[1] Chowdhury S.D., Oommen A.M. Epidemiology of COVID-19. J. Dig. Endosc. 2020;11:3. doi: 10.1055/S-0040-1712187. - DOI

[2] Chowdhury S.D., Oommen A.M. Epidemiology of COVID-19. J. Dig. Endosc. 2020;11:3. doi: 10.1055/S-0040-1712187. - DOI

[3] Wu Z., McGoogan J.M. Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China: summary of a report of 72314 cases from the Chinese center for disease control and prevention. JAMA, J. Am. Med. Assoc. 2020;323:1239–1242. doi: 10.1001/JAMA.2020.2648. - DOI - PubMed

[4] Wu Z., McGoogan J.M. Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China: summary of a report of 72314 cases from the Chinese center for disease control and prevention. JAMA, J. Am. Med. Assoc. 2020;323:1239–1242. doi: 10.1001/JAMA.2020.2648. - DOI - PubMed

[5] Yan R., Zhang Y., Li Y., Xia L., Guo Y., Zhou Q. Structural basis for the recognition of SARS-CoV-2 by full-length human ACE2. Science. 2020;367:1444–1448. doi: 10.1126/science.abb2762. - DOI - PMC - PubMed

[6] Yan R., Zhang Y., Li Y., Xia L., Guo Y., Zhou Q. Structural basis for the recognition of SARS-CoV-2 by full-length human ACE2. Science. 2020;367:1444–1448. doi: 10.1126/science.abb2762. - DOI - PMC - PubMed

[7] Zhu N., Zhang D., Wang W., Li X., Yang B., Song J., Zhao X., Huang B., Shi W., Lu R., Niu P., Zhan F., Ma X., Wang D., Xu W., Wu G., Gao G.F., Tan W. A novel coronavirus from patients with pneumonia in China, 2019. N. Engl. J. Med. 2020;382:727–733. doi: 10.1056/NEJMOA2001017/SUPPL_FILE/NEJMOA2001017_DISCLOSURES.PDF. - DOI - PMC - PubMed

[8] Zhu N., Zhang D., Wang W., Li X., Yang B., Song J., Zhao X., Huang B., Shi W., Lu R., Niu P., Zhan F., Ma X., Wang D., Xu W., Wu G., Gao G.F., Tan W. A novel coronavirus from patients with pneumonia in China, 2019. N. Engl. J. Med. 2020;382:727–733. doi: 10.1056/NEJMOA2001017/SUPPL_FILE/NEJMOA2001017_DISCLOSURES.PDF. - DOI - PMC - PubMed

[9] World Health Organization (WHO), n.d. WHO Coronavirus (COVID-19) Dashboard | WHO Coronavirus (COVID-19) Dashboard With Vaccination Data [WWW Document]. URL https://covid19.who.int/?adgroupsurvey=%7Badgroupsurvey%7D&gclid=Cj0KCQi... (accessed 8.7.23)..

[10] World Health Organization (WHO), n.d. WHO Coronavirus (COVID-19) Dashboard | WHO Coronavirus (COVID-19) Dashboard With Vaccination Data [WWW Document]. URL https://covid19.who.int/?adgroupsurvey=%7Badgroupsurvey%7D&gclid=Cj0KCQi... (accessed 8.7.23)..

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Performance characteristics of INDICAID antigen rapid diagnostic test on SARS-CoV-2 samples during the omicron wave in Cameroon

Affiliations

Performance characteristics of INDICAID antigen rapid diagnostic test on SARS-CoV-2 samples during the omicron wave in Cameroon

Authors

Affiliations

Abstract

Conflict of interest statement

Similar articles

Cited by

References

LinkOut - more resources

Full Text Sources

Miscellaneous

Abstract

Conflict of interest statement

Similar articles

Cited by

References

Related information

LinkOut - more resources

Full Text Sources

Miscellaneous