Analytical sensitivity and clinical sensitivity of the three rapid antigen detection kits for detection of SARS-CoV-2 virus.

BACKGROUND

Numerous rapid antigen detection (RAD) kits for diagnosing COVID-19 patients are available in the market recently.

OBJECTIVE

To compare analytical sensitivity and clinical sensitivity for the three commercially available RAD kits.

STUDY DESIGN

Analytical sensitivity for the detection of SARS-CoV-2 virus was determined by limit of detection (LOD) using RT-PCR as a reference method. Clinical sensitivity was evaluated by using respiratory specimens collected from confirmed COVID-19 patients.

RESULTS

The LOD results showed that the three RAD kits varied from 10-10 fold less sensitive than RT-PCR. Clinical sensitivity of RAD kits ranged from 22.9 %-71.4 % for detecting specimens from COVID-19 patients.

CONCLUSIONS

Although RAD kits were less sensitive than RT-PCR, understanding the clinical characteristics of different RAD kits can guide us to obtain suitable specimens for testing. The likelihood of positive results for RAD kits will be higher.