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Analytical sensitivity and clinical sensitivity of the three rapid antigen detection kits for detection of SARS-CoV-2 virus.
J Clin Virol. 2020 12; 133:104684.JC

Abstract

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 102-105 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.

Authors+Show Affiliations

All from Microbiology Division, Public Health Laboratory Services Branch, Centre for Health Protection, Department of Health, Hong Kong Special Administrative Region, China. Electronic address: so_phls10@dh.gov.hk.All from Microbiology Division, Public Health Laboratory Services Branch, Centre for Health Protection, Department of Health, Hong Kong Special Administrative Region, China.All from Microbiology Division, Public Health Laboratory Services Branch, Centre for Health Protection, Department of Health, Hong Kong Special Administrative Region, China.All from Microbiology Division, Public Health Laboratory Services Branch, Centre for Health Protection, Department of Health, Hong Kong Special Administrative Region, China.All from Microbiology Division, Public Health Laboratory Services Branch, Centre for Health Protection, Department of Health, Hong Kong Special Administrative Region, China.All from Microbiology Division, Public Health Laboratory Services Branch, Centre for Health Protection, Department of Health, Hong Kong Special Administrative Region, China.All from Microbiology Division, Public Health Laboratory Services Branch, Centre for Health Protection, Department of Health, Hong Kong Special Administrative Region, China.All from Microbiology Division, Public Health Laboratory Services Branch, Centre for Health Protection, Department of Health, Hong Kong Special Administrative Region, China.

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

33176236

Citation

Mak, Gannon Ck, et al. "Analytical Sensitivity and Clinical Sensitivity of the Three Rapid Antigen Detection Kits for Detection of SARS-CoV-2 Virus." Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, vol. 133, 2020, p. 104684.
Mak GC, Lau SS, Wong KK, et al. Analytical sensitivity and clinical sensitivity of the three rapid antigen detection kits for detection of SARS-CoV-2 virus. J Clin Virol. 2020;133:104684.
Mak, G. C., Lau, S. S., Wong, K. K., Chow, N. L., Lau, C. S., Lam, E. T., Chan, R. C., & Tsang, D. N. (2020). Analytical sensitivity and clinical sensitivity of the three rapid antigen detection kits for detection of SARS-CoV-2 virus. Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, 133, 104684. https://doi.org/10.1016/j.jcv.2020.104684
Mak GC, et al. Analytical Sensitivity and Clinical Sensitivity of the Three Rapid Antigen Detection Kits for Detection of SARS-CoV-2 Virus. J Clin Virol. 2020;133:104684. PubMed PMID: 33176236.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Analytical sensitivity and clinical sensitivity of the three rapid antigen detection kits for detection of SARS-CoV-2 virus. AU - Mak,Gannon Ck, AU - Lau,Stephen Sy, AU - Wong,Kitty Ky, AU - Chow,Nancy Ls, AU - Lau,C S, AU - Lam,Edman Tk, AU - Chan,Rickjason Cw, AU - Tsang,Dominic Nc, Y1 - 2020/10/29/ PY - 2020/10/07/received PY - 2020/10/14/revised PY - 2020/10/24/accepted PY - 2020/11/12/pubmed PY - 2020/12/30/medline PY - 2020/11/11/entrez KW - 2019 novel coronavirus KW - COVID-19 KW - RT-PCR KW - Rapid antigen detection KW - SARS-CoV-2 SP - 104684 EP - 104684 JF - Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology JO - J Clin Virol VL - 133 N2 - 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 102-105 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. SN - 1873-5967 UR - https://www.unboundmedicine.com/medline/citation/33176236/Analytical_sensitivity_and_clinical_sensitivity_of_the_three_rapid_antigen_detection_kits_for_detection_of_SARS_CoV_2_virus_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1386-6532(20)30426-1 DB - PRIME DP - Unbound Medicine ER -