25 Pack Antigen Rapid Test Kits Oropharyngeal Nasopharyngeal Swab Test

Product Specification

25 Pack Antigen Rapid Test Kits Oropharyngeal Nasopharyngeal Swab Test

COVID-19 Antigen Rapid Test Kit (25-Pack): Oropharyngeal/Nasopharyngeal Swab Test

product description:

The COVID-19 Antigen Detection Kit (Transverse Chromatography) is an immunochromatographic method for the rapid, qualitative detection of SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab samples, either directly or after swab collection. 2 nucleocapsid protein antigens. Added to viral transmission media by individuals suspected of having COVID-19 by a healthcare provider, testing is limited to accredited laboratories that meet requirements to perform moderate, high, or exempt complexity testing. The test is authorized for use at the point of care (POC), which is an inpatient care setting operating on the basis of a certificate of exemption, certificate of compliance, or certificate of accreditation. This test is used to identify SARS-CoV-2 nucleocapsid antigens that are commonly detected in upper respiratory tract samples during the acute phase of infection. A positive result indicates the presence of viral antigens, but clinical correlation with the patient's medical history and other diagnostic information is necessary to determine infection status, and a positive result does not rule out bacterial infection or co-infection with other viruses.

Notice:

Negative results should be considered presumptive, do not exclude SARS-CoV-2 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 conjunction with the patient's recent exposure, medical history, and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed by molecular analysis, if necessary, for patient management.

Product Usage:

This assay is used for the direct and qualitative detection of SARS-CoV-2 antigens in nasopharyngeal and oropharyngeal secretion specimens. Provides clinical results in 15 to 30 minutes, and visual interpretation of results requires no special equipment.

Product Description:

The COVID-19 Antigen Detection Kit (Lateral Chromatography) is intended for use by trained clinical laboratory personnel who have been specifically instructed and trained in in vitro diagnostic procedures and appropriate infection control procedure techniques, as well as in point-of-care settings Individuals with similar training.

Product Instructions:

Sample collection and preparation:

1. Set up the test

2. Remove one extraction tube and one COVID-19 Antigen Detection Kit (Transverse Chromatography) cartridge from the foil bag immediately before testing.

3. Label the test kit and extraction tube for each sample to be tested. Place the labeled extraction tubes on the rack in the designated area of ​​the work area.

Nasal swab specimen collection:

When taking a nasal swab sample, carefully insert the swab (attached in the kit) into the nostril where the most secretions are visually observed. Gently rotate and push the swab to the point of resistance of the turbinate (approximately 2.0-2.5 cm or 1 inch near the nostril), then roll the swab about five times over the nasal wall and remove.

Sample Preparation:

Immediately after specimen collection, immerse the swab in sample extraction buffer.
For complete extraction of the sample, from the swab into the buffer, rotate the swab against the tube wall repeatedly for 10 seconds, then hold the tube (the tube wall is semi-solid) with your fingers and squeeze the swab several times while Slowly remove the swab from the tube. The purpose of the swab against the tube wall is important, as it keeps the liquid-containing specimen in the tube as much as possible. After removing the swab and discarding it into the biohazard waste container, place the nozzle (provided in the kit) tightly on top of the extraction tube and gently shake the tube to thoroughly mix the liquid inside.

Interpretation of results:

Positive Test Result: Visible color lines appear at both the "T" and "C" sites, or a darker color if the "T" site is tested.
Negative test result: Only the "C" reference is colored, the "T" position is blank.
Invalid result: If "C" is empty and no color is displayed, the test result is invalid and the sample needs to be re-tested.