Product Description:

The COVID-19/RSV/Influenza A&B Antigen Test Kit is a lateral flow immunoassay for the qualitative detection of SARS-CoV-2, respiratory syncytial, influenza A and influenza B viral nucleoprotein antigens in nasal swabs from subjects. The symptoms of respiratory viral infection due to SARS-CoV-2, respiratory syncytial, influenza can be similar. The test is intended as an aid in diagnosis of symptomatic individual meeting respiratory infection for SARS-CoV-2 (within the first 7 days of the onset of symptoms) and influenza A/B or Respiratory syncytial virus (RSV) (within the first 4 days of the onset of symptoms). This kit is intended for layperson's home use in a non-laboratory environment. Test results of this kit are for clinical reference only. It is recommended that a comprehensive analysis of the disease be conducted based on clinical manifestations of patients and other laboratory tests.

Precautions:

1. For in vitro diagnostic use only.
2. Do not use after the expiration date.
3. Perform the test at room temperature 15 to 30°C.
4. The test cassette should remain in the sealed pouch until use.
5. Please read all information in this leaflet before performing the test.
6. Components from difference lots must not be mixed or used together.
7. Positive result cannot necessarily determine whether a person is infectious.

Storage and Stability:

Store the test kit in the original packaging at 2°C - 30°C. Do not freeze. Test kit contents remain stable until the expiration date printed on the outer packaging.
After opening the pouch, the test should be used within one hour. Prolonged contact with hot and humid environment will cause the product to deteriorate.

Performance Characteristics:

For COVID-19
Using COVID-19/RSV/Influenza A&B Antigen Test Kit by professional was compared to the RT-PCR kit. A
sensitivity of 95.45% (210/220 known confirmed Positives) and a specificity of 99.03% (307/310 known
confirmed Negatives) were determined for the COVID-19/RSV/Influenza A&B Antigen Test Kit.

For influenza A test
UsingCOVID-19/RSV/Influenza A&B Antigen Test Kit by professional was compared to the RT-PCR kit. A
sensitivity of 93.48%(86/92 known confirmed Positives)and a Specificity of 98.29% (288/293 known confirmed
Negatives)were determined for the COVID-19/RSV/Influenza A&B Antigen Test Kit.

For influenza B test
Using COVID-19/RSV/Influenza A&B Antigen Test Kit by professional was compared to the RT-PCR kit. A
sensitivity of 91.11% (82/90 known confirmed Positives) and a Specificity of 97.89% (278/284 known confirmed
Negatives)were determined for the COVID-19/RSV/Influenza A&B Antigen Test Kit.

For RSV test
Using COVID-19/RSV/Influenza A&B Antigen Test Kit by professional was compared to the RT-PCR kit. A
sensitivity of 94.81% (201/212 known confirmed Positives) and a Specificity of 98.87% (175/177 known
confirmed Negatives)were determined for the COVID-19/RSV/Influenza A&B Antigen Test Kit.

Usability Study
Lay users in different age distribution, different education level and different gender participated in usability
study conducted in the self-testing environment. Compared to RT-PCR, the clinical performance of COVID19/RSV/Influenza A&B Antigen Test Kit in hands of lay persons showed a sensitivity of 94.87% (N=39) and a
specificity of 98.57% (N=70) for COVID-19 antigen, a sensitivity of 94.29% (N=35) and a specificity of 98.57%
(N=70) for RSV antigen, a sensitivity of 90.00% (N=30) and a specificity of 98.57% (N=70) for influenza A
antigen and a sensitivity of 93.33% (N=30) and a specificity of 98.57% (N=70) for influenza B antigen

More Questions:

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