Specifications
Interpretation of Test Results
This product can only perform qualitative analysis on the detection object.
| Positive Result | Negative Result | Invalid Result |
| If both C and T lines are visible within 10 minutes, the test result is positive and valid. | If test area (T line) has no colour and the control area displays a coloured line, the result is negative and valid. | The test result is invalid if a coloured line does not form in the control region. The sample must be re-tested, using a new test card. |
Performance Characteristic
1. Clinical Verification
The performance of Test Card was established with 243 sample collected from symptomatic patients, who with symptoms onset within 7 days.
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| Detected Positive |
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| Detected Negative |
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| Total |
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| Sensitivity | 95.65%, 95% CI (90.22,98.13) |
| Specificity | 98.44%, 95% CI (94.48, 99.57) |
| Accuracy | 97.12%, 95% Cl (94.17,98.60) |
The performance of Test Card with positive results stratified by the comparative method cycle threshold (Ct) counts were collected and assessed to better understand the correlation of assay performance to the cycle threshold, As presented in the table below, the positive agreement of the Test Card is higher with samples of a Ct count <25.
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| Detected Positive |
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| Total |
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| Positive Agreement |
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2. Limit of Detection
The experimental results show that for the virus culture concentration above 100 TCID50/mL, the positive rate of detection is greater than or equal to 95%. For the virus culture concentration of 50 TCID50/mL and below, the positive rate of detection is lower than 95%. So, the limit of detection of the Test Card is 100 TCID50/mL.
3. Cross-reactivity
Cross-reactivity of the test card was evaluated. The results showed no cross reactivity with the following specimen.
The Test Card
The Test Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from 2019-nCoV in saliva specimens directly collected from individuals who are suspected of COVID-19 by their healthcare provider within the first 7 days of symptom onset.
Results
Results are for the identification of 2019-nCoV nucleocapsid protein antigen. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.
The agent detected may not be the definite cause of disease.
Negative results should be treated as presumptive, and do not rule out 2019-nCoV infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management.
