Nayab Afzal1, Naila Tariq2, Saba Raza3, Danish Shakeel4. 1. Clinical Chemistry, National Medical Center, Karachi, PAK. 2. Chemical Pathology, National Medical Center, Karachi, PAK. 3. Clinical Chemistry, Ziauddin University, Karachi, PAK. 4. Hematology, National Medical Center, Karachi, PAK.
Abstract
OBJECTIVE: To determine the diagnostic accuracy of fully automated electro-chemiluminescence immunoassay (ECLIA) anti-SARS-CoV-2 serological test for detection of past SARS-CoV-2 infection and to be used in seroprevalence surveys. METHOD: A total of 426 patients who had tested for anti-SARS-CoV-2 from August 1 to 31, 2020 were selected for the study. Informed consent was obtained and a questionnaire including the patient's age, gender, symptoms, and past polymerase chain reaction (PCR) status was filled by the patient. Samples were analyzed for anti-SARS-CoV-2 antibodies on Roche Cobas e601. RESULTS: The mean age of the patients was 42.43±16.67 years. One hundred and five (24.6%) were PCR positive, while 321 (75.4%) were PCR negative. Most patients were males 241 (56.6%) while 185(43.3%) were females. Over 185(43.3%) patients presented with symptoms, and the rest of the patients 241 (56.6%) were asymptomatic. Anti-SARS-CoV-2 had sensitivity 89.5%, specificity 99.06%, positive predictive value (PPV) 96.90%, negative predictive value (NPV) 96.6%, and positive likelihood ratio 4.26, while negative likelihood ratio 0.1. Diagnostic accuracy of anti-SARS-CoV-2 was 96.7% based on receiver-operating characteristic (ROC) curve analysis. CONCLUSION: Anti-SARS-CoV-2 is very useful for the detection of past COVID-19 infection; it can be proved helpful in the identification of post-COVID complications and actual disease burden in a population.
OBJECTIVE: To determine the diagnostic accuracy of fully automated electro-chemiluminescence immunoassay (ECLIA) anti-SARS-CoV-2 serological test for detection of past SARS-CoV-2 infection and to be used in seroprevalence surveys. METHOD: A total of 426 patients who had tested for anti-SARS-CoV-2 from August 1 to 31, 2020 were selected for the study. Informed consent was obtained and a questionnaire including the patient's age, gender, symptoms, and past polymerase chain reaction (PCR) status was filled by the patient. Samples were analyzed for anti-SARS-CoV-2 antibodies on Roche Cobas e601. RESULTS: The mean age of the patients was 42.43±16.67 years. One hundred and five (24.6%) were PCR positive, while 321 (75.4%) were PCR negative. Most patients were males 241 (56.6%) while 185(43.3%) were females. Over 185(43.3%) patients presented with symptoms, and the rest of the patients 241 (56.6%) were asymptomatic. Anti-SARS-CoV-2 had sensitivity 89.5%, specificity 99.06%, positive predictive value (PPV) 96.90%, negative predictive value (NPV) 96.6%, and positive likelihood ratio 4.26, while negative likelihood ratio 0.1. Diagnostic accuracy of anti-SARS-CoV-2 was 96.7% based on receiver-operating characteristic (ROC) curve analysis. CONCLUSION: Anti-SARS-CoV-2 is very useful for the detection of past COVID-19infection; it can be proved helpful in the identification of post-COVID complications and actual disease burden in a population.
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