Evaluation of the INDICAIDâ„¢ COVID-19 Rapid Antigen Test in symptomatic populations and asymptomatic community testing

  1. Ricky Y. T. Chiu
  2. Noah Kojima
  3. Garrett Lee Mosley
  4. Kwok Kin Cheng
  5. David Y. Pereira
  6. Matthew Brobeck
  7. Tsun Leung Chan
  8. Jonpaul Sze-Tsing Zee
  9. Harsha Kittur
  10. Tenny Cheuk-Yiu Chung
  11. Eric Tsang
  12. Kajal Maran
  13. Raymond Wai-Hung Yung
  14. Alex Chin-Pang Leung
  15. Ryan Ho-Ping Siu
  16. Jessica Pui-Ling Ng
  17. Tsz Hei Choi
  18. Mei Wai Fung
  19. Wai Sing Chan
  20. Ho Yin Lam
  21. Koon Hung Lee
  22. Sean Parkin
  23. Felix C. Chao
  24. Stephen Ka-Nung Ho
  25. Daniel R. Marshak
  26. Edmond Shiu-Kwan Ma
  27. Jeffrey D. Klausner
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Abstract

Background

As the COVID-19 pandemic continues to cause substantial morbidity and mortality, there is an increased need for rapid, accessible assays for SARS-CoV-2 detection.

Methods

Here we present a clinical evaluation and real-world implementation of the INDICAID™ COVID-19 Rapid Antigen Test (INDICAID™ Rapid Test). A multi-site clinical evaluation of the INDICAID™ Rapid Test using prospectively collected samples from symptomatic subjects was performed. The INDICAID™ Rapid Test was then implemented at COVID-19 outbreak screening centers in Hong Kong to screen individuals for COVID-19 to prioritize confirmatory RT-PCR testing among asymptomatic populations.

Results

The clinical evaluation in symptomatic patient populations demonstrated a positive percent agreement and negative percent agreement of 85.3% (95% confidence interval [95% CI]: 75.6% - 91.6%) and 94.9% (95% CI: 91.6% - 96.9%), respectively, when compared to laboratory-based RT-PCR testing. When used during outbreak testing of 22,994 asymptomatic patients, the INDICAID™ Rapid Test demonstrated a positive percent agreement of 84.2% (95% CI: 69.6% - 92.6%) and a negative percent agreement of 99.9% (95% CI: 99.9% - 100%) compared to laboratory-based RT-PCR testing. When incorporated in a testing algorithm, the INDICAID™ Rapid Test reduced time to confirmatory positive result from an average 10.85 hours (standard RT-PCR only) to 0.84 hours, depending on the algorithm.

Conclusion

The INDICAID™ Rapid Test has excellent performance when compared to laboratory-based RT-PCR testing, and when used in tandem with RT-PCR, reduces the time to confirmatory positive result.

Summary

In clinical evaluations, the INDICAID™ COVID-19 Rapid Antigen Test demonstrated high sensitivity and specificity in symptomatic and asymptomatic patient populations. When used in tandem with RT-PCR testing, the INDICAID™ Rapid Test expedited confirmatory results and may help reduce SARS-CoV-2 outbreaks.

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