XÁC NHẬN GIÁ TRỊ CHẨN ĐOÁN LÂM SÀNG CỦA BỘ SINH PHẨM XÉT NGHIỆM NHANH KHÁNG NGUYÊN VIRUS SARS-CoV-2 TẠI BỆNH VIỆN NGUYỂN TRI PHƯƠNG

Abstract

Objective: Determine the sensitivity and specificity of the Panbio COVID-19 Ag Rapid Test Device (Abbott Diagnostics, Korea) at Nguyen Tri Phuong Hospital. Subjects and methods: Cross-sectional study performed on 783 retrospective samples were randomly selected from 3,375  cases performed both realtime RT-PCR test and antigen rapid test from July 1st, 2021 to September 30th, 2021 at Nguyen Tri Phuong Hospital. Results: In 442 realtime RT-PCR cases had positive results with SARS-CoV-2, 337 cases had positive with rapid test and 105 cases were negative. The overall sensitivity of the Panbio COVID-19 Ag Rapid Test Device was 76.2% (95% CI 72,3-80,2), and the specificity was 99.1% (95% CI 98,1-100). The sensitivity of the group Ct values < 25,  the group Ct values 25-30 and the group Ct values > 30was 93,8%, 50,0% and 18,2%, respectively. Conclusions: Compared with the realtime RT-PCR results, the Panbio Covid-19 antigen rapid test conducted at Nguyen Tri Phuong Hospital has overall the sensitivity and specificity accomplished the requirements of the Ministry of Health. When separately considered in each of Ct values group, the sensitivity is inversely proportional to the Ct values. This observation contributes to raising awareness about the screening roles of the Covid-19 antigen rapid test and building a strategy to use this rapid test more efficiently at Nguyen Tri Phuong Hospital.