The performance of the kit was established using clinical samples, with kit results compared to nucleic acid test results. The kit showed sensitivity of 96.330% and specificity of 99.569%. In addition, separate oropharyngeal swabs, nasal swabs and nasopharyngeal swabs were collected from 50 patients and compared for homologous consistency. There was agreement in paired results (100% in all cases) from nasal swabs and oropharyngeal swabs, nasopharyngeal swabs and oropharyngeal swabs, and nasal swabs and nasopharyngeal swabs.
This SARS-CoV-2 antigen rapid test kit does not cross-react with samples of: Staphylococcus aureus, Streptococcus pneumoniae, measles virus, mumps virus, adenovirus type 3, Mycoplasma pneumoniae, parainfluenza virus type 2, metapneumovirus, coronavirus OC43, coronavirus 229E, Bacillus parapertussis , Type B influenza virus Victoria line, Type B influenza virus Y line, Type A influenza virus H1N1, Type A influenza virus H3N2, Avian influenza virus H7N9, Avian influenza virus H5N1, Epstein-Barr virus, Enterovirus CA16, Rhinovirus.
This SARS-CoV-2 antigen rapid test kit did not show false negative or false positive results when patients had been treated with: Histamine dihydrochloride, Zanamivir, Ribavirin, IFN-a, Oseltamivir, Paramivir, Lopinavir, Ritonavir, Arbidol, Levofloxacin, Azithromycin, Ceftriaxone, MeropeneM, Tobramycin.
- This kit is for clinical in vitro diagnosis only.
- Please read the instructions carefully before testing, and operate in strict accordance with the instructions.
- Different batches of reagents and treatment solutions should not be mixed.
- Sample collection, storage and testing should be in strict accordance with the novel Coronavirus related testing technical guides and biosafety guides. The remaining sample disposal solution, swabs, test cassettes and all wastes must be disposed of in accordance with laboratory biosafety requirements.
- It is recommended to treat the waste as infectious material, and use ethyl ether, 75% ethanol, chlorine-containing disinfectant, peracetic acid, chloroform and other solvents to soak the waste generated during the detection process, to inactivate the virus.
- The test cassette is ready to use, valid within 1 hour after opening, and the test cassette cannot be reused.
- The test results of this kit are for clinical reference only. Diagnosis should be made after comprehensive judgment of the clinical symptoms, signs, medical history and other laboratory examination results of the patient.