Sensitivity and Specificity of a COVID-19 Lateral Flow Immunoassay Compared to RT-PCR in Pregnant Womenat Arifin Achmad General Hospital Pekanbaru, Indonesia

Abstract

Coronavirus disease 2019 (COVID-19) is significant global treat including to pregnant woman in Indonesia.
A point-of-care diagnostic tool that is able to early diagnose and hasa good sensitivity and specificity is
critical during the pandemic. The aim of this study was to describe the clinical, laboratory and outcomes
of pregnant women with presumptive COVID-19 and to compare the sensitivity and specificity between
COVID-19 rapid test (lateral flow immunoassay) and real-time reverse transcription polymerase chain
reaction (RT-PCR). Pregnant women with presumptive COVID-19 symptoms were recruited at Arifin
Achmad General Hospital between April 2020 and December 2020. Demographic and clinical data were
collected and patients were tested with COVID-19 rapid test as well as RT-PCR. Analyze was conducted to
determine the sensitivity and specificity. We included 120 patients with presumptive COVID-19 of which
48 (40%) and 72 (60%) of patients were reactive for IgM and IgG antibody anti severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2), respectively and 51 (42.5%) were reactive for both IgM and IgG.
The sensitivity and the specificity of rapid test was 64.0% and 33.3%, respectively. The positive and negative
predictive value was 61.5% and 35.7%, respectively. In conclusion, lateral flow immunoassay-based rapid
test has relatively low sensitivity and specificity in diagnosing COVID-19 in pregnant women.