A Novel Strategy for SARS-CoV-2 Mass-Screening Using Quantitative Antigen Testing of Saliva

Yokota, Isao; Shane, Peter Y.; Okada, Kazufumi; Unoki, Yokota; Yang, Yichi; Iwasaki, Shinya; Fujisawa, Shinichi; Nishida, Mutsumi; Teshima, Takanori

doi:10.2139/ssrn.3719066

Cited by 2 publications

(5 citation statements)

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“…Although PCR is a standard of care for the detection of SARS-CoV-2, mandatory mass-screening should ideally avoid time-consuming and labor-intensive procedures. In this regard, quantitative antigen test by CLEIA is rapid albeit with slightly less accuracy than PCR 17 . Therefore, our two-step strategy combined the utility of initial CLEIA with the accuracy of NAAT only for diagnosis of indeterminate cases.…”

Section: Discussionmentioning

confidence: 98%

“…the ratio of undetected infectees to persons diagnosed as infected). Four scenarios with p values of 0·1%, 0·2%, 0·5%, and 1·0% were used for analyses, with a factor of 0.76 (probability of CLEIA positivity given NAAT positivity) applied to the p values for the two-step strategy, consistent with our previous report 17 . FN/Pos was set at 0·4 in accordance to a recent report showing 136 and 52 positive results at airport screening and during post-entry compulsory quarantine, respectively 18 .…”

Section: Methodsmentioning

confidence: 97%

“…Initially, all specimens were tested by CLEIA with positive and negative thresholds of 4.0pg/mL and 0.67pg/mL, respectively, as previously reported 17 . Concentrations in between the thresholds were considered indeterminate, and only these specimens underwent confirmatory testing by NAAT.…”

Section: Methodsmentioning

confidence: 99%

“…Lumipulse SARS-CoV-2 Ag kit (Fujirebio, Tokyo, Japan), a sandwich CLEIA using monoclonal antibodies that recognize SARS-CoV-2 N-Ag on LUMIPULSE G1200 automated machine (Fujirebio), was used as previously described 17 . The detection range is between 0.01 pg/mL and 5000 pg/mL.…”

Section: Methodsmentioning

confidence: 99%

“…Recently, we and others have shown the utility of a novel quantitative antigen test using chemiluminescent enzyme immunoassay (CLEIA) and reverse transcriptase loop-mediated isothermal amplification (LAMP) to detect SARS-CoV-2 proteins and nucleic acids, respectively, within 30 minutes 14, 16 . Accordingly, a novel two-step strategy using these tests have been implemented for mass screening of SARS-CoV-2 at airport quarantines in Japan 17 . We herein evaluated utility of this strategy in 88,924 persons and estimated its performance in several clinical scenarios.…”

Section: Introductionmentioning

confidence: 99%

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

Yokota

Shane

Teshima

2021

Preprint

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SummaryBackgroundAirport 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.Methods88,924 (93.2%) of 95,457 arrivals at three international airports in Japan 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.Results254 (0.27%) persons were found to be SARS-CoV-2 antigen positive (≥ 4.0 pg/mL) by CLEIA. NAAT was required for confirmatory testing in 513 (0.54%) persons with intermediate antigen concentrations (0.67-4.0 pg/mL) whereby the virus was detected in 34 (6.6%) persons. This two-step strategy dramatically reduced the utilization of NAAT to approximately one out of every 200 test subjects.Estimated performance of this strategy did not show significant increase in false negatives as compared to performing NAAT in all subjects. Further reduction in imported cases may be achieved by post-screening quarantine.ConclusionsPoint 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.

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Section: Discussionmentioning

confidence: 98%

Section: Methodsmentioning

confidence: 97%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Yokota

Shane

Teshima

2021

Preprint

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Evaluation of a saliva molecular point of care for the detection of SARS-CoV-2 in ambulatory care

LeGoff

Kernéis

Elie

et al. 2021

Sci Rep

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Rapid identification of SARS-CoV-2-infected individuals is a cornerstone for the control of virus spread. The sensitivity of SARS-CoV-2 RNA detection by RT-PCR is similar in saliva and nasopharyngeal swabs. Rapid molecular point-of-care tests in saliva could facilitate, broaden and speed up the diagnosis. We conducted a prospective study in two community COVID-19 screening centers to evaluate the performances of a CE-marked RT-LAMP assay (EasyCoV) designed for the detection of SARS-CoV2 RNA from fresh saliva samples, compared to nasopharyngeal RT-PCR, to saliva RT-PCR and to nasopharyngeal antigen testing. Overall, 117 of the 1718 participants (7%) tested positive with nasopharyngeal RT-PCR. Compared to nasopharyngeal RT-PCR, the sensitivity and specificity of the RT-LAMP assay in saliva were 34% and 97%, respectively. The Ct values of nasopharyngeal RT-PCR were significantly lower in the 40 true positive subjects with saliva RT-LAMP (Ct 25.9) than in the 48 false negative subjects with saliva RT-LAMP (Ct 28.4) (p = 0.028). Considering six alternate criteria for reference tests, including saliva RT-PCR and nasopharyngeal antigen, the sensitivity of saliva RT-LAMP ranged between 27 and 44%. The detection of SARS-CoV-2 in crude saliva samples with an RT-LAMP assay had a lower sensitivity than nasopharyngeal RT-PCR, saliva RT-PCR and nasopharyngeal antigen testing.Registration number: NCT04578509.

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A Novel Strategy for SARS-CoV-2 Mass-Screening Using Quantitative Antigen Testing of Saliva

Cited by 2 publications

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

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

Evaluation of a saliva molecular point of care for the detection of SARS-CoV-2 in ambulatory care

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