Validity of COVID-19 Rapid Tests in Iraq
Abstract
Background: Since the inception of the Coronavirus Disease-2019 (COVID-19) pandemic caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS- CoV-2) several methods were developed to identify and diagnose the disease such as rapid Polymerase Chain Reaction (PCR) test, rapid antibody test, and rapid antigen test. In Iraq, no study had evaluated the accuracy of the rapid antibody test before introducing it into the field.
Objective: To assess the validity of the rapid test (Dutch-made Biozek) used in Iraq through calculating the sensitivity, specificity, positive and negative predictive values on a sample of suspected COVID-19 cases.
Materials and Methods: A descriptive cross-sectional study conducted at two Primary Healthcare Centers (PHCs); 1000 individuals were included either because of the classical symptom of the disease and attended the PHC for testing or they were healthy individuals with close contact with a confirmed case at home or work. A structured questionnaire was filled in through direct interviews with the participants. Both rapid antibody test and PCR test were done simultaneously. The sensitivity, specificity, positive and negative predictive values were calculated.
Results: Around 85% aged 20-60 years with almost equal gender distribution. About 78% were symptomatic, and 32.6% had history of contact with a confirmed case. The sensitivity was 14% for Immunoglobin (Ig) G, 3.2% for IgM and 5.7% for both, compared to specificity which was 74.5% for IgG, 95.1% for IgM and 91.3% for both. While the Positive Predictive Value (PPV) was 32.8% for IgG, 36.6% for IgM, and 37% for both, and the Negative Predictive Value (NPV) was 49.3% for IgG, 52.5% for IgM and 52.1% for both.
Conclusion: Rapid antibody test used in this study which is not generally recommended for the early diagnosis of COVID-19 patients or in the screening programs. However, it can be used for epidemiological surveys purposes.