Logistic advantage of two-step screening strategy for SARS-CoV-2 at airport quarantine

Background: Airport quarantine is required to reduce the risk of entry of travelers infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, it is challenging for both high accuracy and rapid turn-around time to coexist in testing; polymerase chain reaction (PCR) is time-consuming with high accuracy, while antigen testing is rapid with less accuracy. However, there are few data on the concordance between PCR and antigen testing. Methods: Arrivals at three international airports in Japan between July 29 and September 30, 2020 were tested for SARS-CoV-2 using self-collected saliva by a screening strategy with initial chemiluminescent enzyme immunoassay (CLEIA) followed by confirmatory nucleic acid amplification tests (NAAT) only for intermediate range antigen concentrations. Results: Among the 95,457 persons entering Japan during the period, 88,924 (93.2%) were tested by CLEIA, and 0.29% (254/88,924) were found to be SARS-CoV-2 antigen positive (>= 4.0 pg/mL). NAAT was required for confirmatory testing in 0.58% (513/88,924) with intermediate antigen concentrations (0.67-4.0 pg/mL) whereby the virus was detected in 6.6% (34/513). This two-step strategy reduced the utilization of NAAT to one out of every 173 test subjects. The estimated performance of this strategy did not show significant increase in false negatives as compared to performing NAAT in all subjects. Conclusions: Point of care testing by quantitative CLEIA using self-collected saliva is less labor-intensive and yields results rapidly, thus suitable as an initial screening test. Reserving NAAT for CLEIA indeterminate cases may prevent compromising accuracy while significantly improving the logistics of administering mass-screening at large venues.