COVID-19 Antigen Rapid Detection Kit (Cassettes)
COVID-19 Antigen Test Procedure
1.Twist off the cap of the buffer bottle, carefully dispense all buffer into the extraction tube。
2.After collecting upper respiratory sample with nasal swab, insert the swab into the extraction tube, plunge the swab up and down in the fluid for a minimum of 10 seconds. Hold the swab against the bottom of the tube, rotate three turns. DO NOT splash liquid out of the tube.
3.Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.
4.Press the nozzle cap firmly onto the extraction tube. Mix thoroughly by swirling or flicking the bottom of the tube.
5.Gently squeeze the tube’s rigid body, dispense two (2) drops of the buffer-specimen mixture into the sample well on the coronavirus antigen test cassette.
6.Read the test results between 15 and 20 minutes. Do not read the results after 20 minutes.
Intended Use:
The kit is used for the detection of novel coronavirus and novel coronavirus mutant strain(B.1.1.7 strain)in oropharyngeal swabs and nasopharyngeal swab samples of people suspected of novel coronaviruse infection with pneumonia. The antigen testing is generally used for sample testing within 7 days of the onset of symptoms in the suspected population during the acute infection period.
The results should be combined with nucleic acid testing, imaging and other diagnostic information, medical history and contact history to determine the infection status.
Storage Conditions and Shelf Life:
Stored in a dry place at 2-30 ℃ and the shelf life is 18 months.
Detection Principle:
The kit uses the principle of the colloidal gold sandwich method to qualitatively detect the novel coronavirus antigen and the novel coronavirus mutant (B.1.1.7 strain) antigen in human throat swabs and nasopharyngeal swab samples.
Sample Requirements:
Laryngeal secretion and nasopharyngeal secretion
The SARS-CoV-2 Antigen rapid test showed no interference from the following substances (see data sheet for concentrations tested): Mucin, Whole Blood, Biotin, Histamine dihydrochloride, IFN-a, Zanamivir, Ribavirin, Oseltamivir, Paramivir, Lopinavir, Ritonavir, Arbidol, Levofloxacin, Azithromycin, Ceftriaxone, Meropenem, Tobramycin, Antinuclear antibody (ANA), Anti-mitochondrial antibody (AMA), or Mouse IgG.
The Influenza Antigen Rapid Test showed no interference from the following substances (see data sheet for concentrations tested): Whole Blood, Mucin, pus, Aspirin, N-acetaminophen, Ibuprofen, Ribavirin, Oseltamivir, Cephalexin, Gentamicin, Tetracycline, Chloramphenicol, Moxifloxacin, Hydrocortisone, Artificial Insulin, and other drugs.
★ Do not use the kit past its expiration date.
★ Swabs, tubes, and test devices are single use only.
★ The extraction buffer contains a solution with a preservative (0.05% Proclin 300). If the solution comes into contact with the skin or eyes, flush with ample volumes of water.
★ Do not interchange or mix components from different kit lots.
★ When collecting an oropharyngeal, nasal, or nasopharyngeal swab sample, only use the suitable swabs supplied in the kit.
★ Wear appropriate personal protective equipment and gloves when running each test and handling patient specimens. Change gloves between handling of specimens suspected of COVID-19.
★ Specimens must be processed as indicated in the SPECIMEN COLLECTION and SAMPLE PREPARATION PROCEDURE sections of the product insert. Failure to follow the instructions for use can result in inaccurate results.
★ To obtain accurate results, do not use visually bloody or overly viscous samples.
★ Proper laboratory safety techniques should be followed at all times when working with SARS-CoV-2 patient samples. Patient swabs, used Test Strips, and used extraction buffer vials may be potentially infectious. Proper handling and disposal methods should be established by the laboratory in accordance with local regulatory requirements.
★ Humidity and temperature can adversely affect results.
