SET DA 25 TEST CLUNGENE® COVID-19 Antigen Rapid Test Cassette (Nasal Swab)

SET DA 25 TEST CLUNGENE® COVID-19 Antigen Rapid Test Cassette (Nasal Swab)

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SET DA 25 TEST CLUNGENE® COVID-19 Antigen Rapid Test Cassette (Nasal Swab)

COVID-19 Antigen Rapid Test
Clinical Sensitivity and Specificity Study Report
1. Objective
The CLUNGENE® COVID-19 Antigen Rapid Test (hereinafter referred to as the CLUNGENE Device)
manufactured by Hangzhou Clongene Biotech Co., Ltd. is a lateral flow immunoassay intended for the
qualitative detection SARS-CoV-2 nucleocapsid antigens in nasopharyngeal swab and oropharyngeal swab
from individuals who are suspected of COVID-19 by their healthcare provider.
This study is intended to evaluate the clinical performance, between the CLUNGENE Device and the
comparator RT-PCR assay.
2. Method
A study of 770 direct nasopharyngeal swabs was performed. The specimens were prospectively collected from
patients in community meeting Department of Public Health definition of a suspected COVID-19 case and
being tested for SARS-CoV-2 part of routine medical care at 5 locations and tested at a single central
laboratory.
Two nasopharyngeal swabs were collected from individual symptomatic (within 7 days of onset) or
asymptomatic patients who were suspected of COVID-19. At all locations, one nasopharyngeal swab was
tested directly with the COVID-19 Antigen Rapid Test according to product instructions for use, and the other
swab was eluted in 3 mL viral transport media and tested with RT-PCR assay for detection of SARS-CoV-2.
Swabs were randomly assigned to testing with the COVID-19 Antigen Rapid Test or RT-PCR assay and were
tested by operators who were blinded to the RT-PCR test result.
The positive percent agreement (PPA) was calculated as 100% x (True Positive/[True Positive+False Negative]).
The negative percent agreement (NPA) was calculated as 100% x (True Negative / [True Negative + False
Positive]). Accuracy was calculated as 100% x ([True Positive+ True Negative] /Total sample Qty). The 95%
(two-sided) confidence interval (CI) was calculated using the Wilson Score Method.
3. Comparator method
Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2, manufactured by BGI Genomics Co. Ltd., is a
real-time reverse transcription polymerase chain reaction (rRT-PCR) test. This product has got CE, NMPA
certification and FDA Emergency Use Authorized. A specimen is positive for SARS-CoV-2 if the Ct value of
ORF1ab gene is not higher than 37 and the Ct value of human housekeeping gene β-Actin is not higher than 35.
4. Enrollment criteria (inclusion/exclusion criteria)
4.1 Inclusion criteria
 Patients in community meeting Department of Public Health definition of a suspected COVID-19 case and
being tested for SARS-CoV-2 part of routine medical care.
 Symptomatic (within 7 days of onset) or asymptomatic patients who were suspected of COVID-19.
4.2 Exclusion criteria
 Unable to obtain samples of information needed for the experiment
 Samples that have been contaminated or contaminated during sample storage
 Samples with inappropriate storage conditions
5. Result
The results are summarized in the following table.
The RT-PCR cycle threshold (Ct) is the relevant signal value. Lower Ct value indicate higher viral load. The
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sensitivity was calculated for the different Ct value range (Ct value≤33 and Ct value≤37).
COVID-19Antigen
RT-PCR (Ct value≤33)
Total
Positive Negative
CLUNGENE®
Positive 145 2 147
Negative 3 593 596
Total 148 595 743
PPA (Ct≤33): 98.0% (145/148), (95%CI: 94.2%~99.3%)
NPA: 99.7% (593/595), (95%CI: 98.8%~99.9%)
Accuracy: 99.3%((145+593)/743), (95%CI: 98.4%~99.7%)
COVID-19Antigen
RT-PCR (Ct value≤37)
Total
Positive Negative
CLUNGENE®
Positive 161 2 163
Negative 14 593 607
Total 175 595 770
PPA (Ct≤37): 92.0% (161/175), (95%CI: 87.0%~95.2%)
NPA: 99.7% (593/595), (95%CI: 98.8%~99.9%)
Accuracy: 97.9%((161+593)/770), (95%CI: 96.6%~98.7%)
PPA – Positive Percent Agreement (Sensitivity)
NPA – Negative Percent Agreement (Specificity)
6. Conclusion
Taken together, the CLUNGENE® COVID-19 Antigen Rapid Test had a positive percent agreement (sensitivity)
of 98.0% (95%CI: 94.2%~99.3%) with specimens of a Ct count ≤33, 92.0% (95%CI: 87.0%~95.2%)
with specimens of a Ct count ≤37, negative percent agreement (specificity) of 99.7% (95%CI: 98.8%~
99.9%), and accuracy of 99.3% (95%CI: 98.4%~99.7%) with specimens of a Ct count ≤33, 97.9%
(95%CI: 96.6%~98.7%) with specimens of a Ct count ≤37.

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  • SET DA 25 TEST CLUNGENE® COVID-19 Antigen Rapid Test Cassette (Nasal Swab)