Home Use Covid Antigen Rapid Test

LIMITATIONS OF THE TEST 

1. Home Use COVID-19 Antigen Rapid Test Device (Colloidal Gold) is for in vitro diagnostic use, and should only be used for the qualitative detection of COVID-19 antigen.

2. This test has been authorized only for the detection of proteins from COVID-19, not for any other viruses or pathogens.

3. The etiology of respiratory infection caused by microorganisms other than Home Use COVID-19 virus will not be established with this test. The COVID-19 antigen Rapid Test Device (Colloidal Gold) is capable of detecting both viable and non-viable COVID-19 particles. The performance of the COVID-19 antigen Rapid Test Device (Colloidal Gold) depends on antigen load and may not correlate with PCR performed on the same specimen.

4. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at anytime rule out the presence of Home Use COVID-19 viral antigens in specimen, as they may be present below the minimum detection level of the test. As with all diagnostic tests, a confirmed diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.

5. The validity of Home use COVID-19 Antigen Rapid Test Device (Colloidal Gold) has not been proven for identification or confirmation of PCR.

6. Inadequate or inappropriate specimen collection may yield false negative test result.

7. Children tend to shed virus for longer periods of time than adults, which may result in differences in sensitivity between adults and children.

8. Positive and negative predictive values are highly dependent on prevalence. False positive test results are more likely during periods of low COVID activity when prevalence is moderate to low.

9. Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. 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.

10. Negative test results are not intended to rule in other non-SARS viral or bacterial infections.

11. Negative results, from patients with symptom onset beyond five days, should be treated as presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed.

12. If the differentiation of specific SARS viruses and strains is needed, additional testing, in consultation with state or local public health departments, is required.

Interpretation of Results

Positive(+): Red bands appear at both of T and C line in 15 to 30 minutes. A white band at

the T line should be considered as a negative result.

Negative(-): A red band appears at C line while no red band appears at T line in 15 to 30

minutes after sample loading.

Invalid: As long as no red band appears at C line, it indicates that the test result is invalid,

and should retest the sample with another test card.

QUALITY CONTROL 

Internal procedural controls are included in the test. A colored band appearing in the control region (C) is considered an internal positive procedural control, confirming sufficient specimen volume and correct procedural technique.

Certificate

Lysun is granted "white list" membership by Chinese Ministry of Commerce for the anti-epidemic products exportation. At present, Lysun COVID-19 Antigen Rapid Test Device has been registered in many countries including Germany, France, Italy, Switzerland, Slovakia, Czech, Indonesia, Thailand, Malaysia etc., and passed the clinical validation in national lab in Germany, Switzerland, Malaysia, etc. 

LIMIT OF DETECTION (LOD)

The minimum detection limit of the home use product is 150 TCID50/m

Note: 

It can be used to understand the chance that a test will give a positive result for someone who actually has coronavirus; ﹩ : It can be used to understand the chance that a test will give a negative result for someone who does not have coronavirus; *: It can be used to understand the chance that a test will give a correct result for someone who actually has coronavirus or not; For SARS-CoV-2 Variant: 5 SARS-CoV-2 Variant omicron and delta samples had been verified in the clinical performance study respectively. The test result is listed as follow: Relative sensitivity of variant omicron: 5/5=99.99% (47.82%～100.00%) Relative sensitivity of variant delta: 5/5=99.99% (47.82%～100.00%)

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HANGZHOU LYSUN BIOTECHNOLOGY CO., LTD. 6th Floor, 6th Building, No.95 Binwen Road, Xixing Street, Binjiang District, Hangzhou, Zhejiang,China.