Performance characteristics of INDICAID antigen rapid diagnostic test on SARS-CoV-2 samples during the omicron wave in Cameroon.
Heliyon
; 10(9): e29937, 2024 May 15.
Article
em En
| MEDLINE
| ID: mdl-38694118
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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Idioma:
En
Revista:
Heliyon
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Camarões