Comparative Evaluation of Commercially available Rapid Diagnostic Test Kits for the use of Screening of Suspected Cases of Novel Coronavirus infection in Nepal
Comparative evaluation study was conducted by Nepal Health Research Council (NHRC), in collaboration with Ministry of Health and Population (MoHP), Epidemiology and Disease Control Division (EDCD), and National Public Health Laboratory (NPHL) in Sudurpashchim Province to evaluate commercially available RDTs for SARS CoV2 (COVID 19) against the most sensitive and WHO/CDC standardized rRT-PCR and to establish the laboratory based confirmation of the COVID19 cases among the clinically suspected referred cases.
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A hospital based quantitative cross sectional study was conducted during ongoing outbreak of 2020 month of April. A total of 200 cases were enrolled in the study using consecutive sampling. Probable and suspected cases for COVID-19 admitted in hospitals (isolation/ quarantine for covid-19) were recruited for the study.
Sensitivity and Specificity
The result of study shows that the sensitivities of the Wondfo Kits were 50%, and the specificities were 99.5% (Compared to the reference standard (RT-PCR)). Similarly, positive and negative predictive values of the test kit were 66.7% and 99% respectively. Similarly, accuracy was 98.5%.
- Sensitivity: TP/ (TP + FN) × 100, 2/4× 100 = 50%
- Specificity: TN/ (TN+FP) × 100,195/196 × 100=99.5%
- Positive Predictive Value (PPV): TP/ (TP + FP) × 100, 2/3 × 100 = 66.7%
- Negative Predictive Value (NPV): TN/ (TN + FN) × 100, 196/197 × 100 = 99%
- Accuracy: TP+TN/TP+TN+FP+FN× 100, 197/200× 100 = 98.5%
Comparative evaluation of RDTs and RT-PCR
RDTs (Test) | RT-PCR (confirmatory) | ||
| Positive | Negative | Total | |
Positive | 2 (TP) | 1 (FP) | 3 |
Negative | 2 (FN) | 195 (TN) | 197 |
Total | 4 | 196 | 200 |
Conclusion of study
Comparative evaluation of RDTs against confirmatory diagnosis of COVID-19 (RT-PCR) showed moderate sensitivity, but high specificity and desirable accuracy. The accurate diagnosis of people infected with the SARS-CoV-2 is essential to control the global spread of COVID-1. The existing clinical accuracy of rapid tests still needs to be stringently evaluated before they are authorized for the mass screening of COVID-19. Hence, RDTS could be used as complementary to the existing RT-PCR assays, which could lead to much better diagnosis of COVID-19 and provide additional information about the immune status of the cases and community as well as for rapid surveillance where there is no amenities of laboratory facilities for RT-PCR test.
For more results please download final report (NHRC)
For additional information, please contact: Nepal Health Research Council (NHRC) Ramshah Path, Kathmandu Phone no: +977-1-4254220 / +977-1-4254220 Email: [email protected]
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