FDA Approved Covid Rapid Test Kit Antigen Test Kit Rapid Test IgG IgM

Rapid Test Kits

FDA Approved Covid Rapid Test Kit Antigen Test Kit Rapid Test IgG IgM

Description of COVID-19 Antigen Detection Kit:

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 following 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 moderate, high, or exempt complexity testing by accredited laboratories. The test is authorized for use at the point of care (POC), an inpatient care setting that operates on the basis of a certificate of waiver, certificate of compliance, or a certificate of accreditation. This test is used to identify SARS-CoV-2 nucleocapsid antigens typically detected in upper respiratory samples during the acute phase of infection. A positive result indicates the presence of viral antigens but requires clinical correlation with the patient's medical history and other diagnostic information to determine infection status, and a positive result does not exclude bacterial infection or co-infection with other viruses.

Precautions for COVID-19 Antigen Test Kits:

A negative result from the COVID-19 antigen test kit should be considered presumptive, does 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.

COVID-19 Antigen Detection Kit Uses:

The COVID-19 Antigen Detection Kit test method 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 does not require special equipment.

Description of the COVID-19 Antigen Test Kits:

COVID-19 Antigen Test Kits Sample collection to prepare for testing:

Before testing with the COVID-19 Antigen Test Kits, remove one extraction tube and one COVID-19 Antigen Test Kit (Transverse Chromatography) from the foil bag, and 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. See Figure 1.

COVID-19 Antigen Test Kits Nasal Swab Specimen Collection:

When collecting nasal swab samples with the COVID-19 Antigen Test Kits, carefully insert the swab (provided in the kit) into the nostril where the most secretions are visually observed. Gently rotate, pushing the swab until it meets resistance at the level of the turbinate (approximately 2.0-2.5 cm or nearly 1 inch into the nostril). Roll the swab around the nose wall about 5 times and remove it from the nostril.

COVID-19 Antigen Test Kits Sample Preparation:

Unscrew the cap of the sample extraction buffer bottle, squeeze the sample extraction buffer bottle, and add the sample extraction buffer to the extraction tube. (See Figure 2) Immediately after specimen collection, immerse the swab in sample extraction buffer. (See Figure 3) To fully penetrate the extracted sample into the swab's buffer, rotate the swab against the tube wall repeatedly for 10 seconds, then hold the tube with your fingers (the tube wall is semi-solid) and squeeze and wipe Several times, slowly remove the swab from the tube at the same time. (See Figure 4) The purpose of squeezing the swab against the tube wall is important because it retains as much liquid-laden sample as possible in the tube. After removing the swab and discarding it in the biohazard waste container, tie the nozzle (provided in the kit) to the top of the extraction tube and gently shake the tube to thoroughly mix the liquid inside, see Figure 5.

Interpretation of COVID-19 Antigen Test Kits results:

Positive COVID-19 Antigen Test Kits: Visible colored lines at both "T" and "C" sites, darker if the "T" site is tested.
COVID-19 Antigen Test Kits Negative Test Results: Only the "C" reference is colored, the "T" position is blank.
COVID-19 Antigen Test Kits Invalid Result: If "C" is blank and no color is displayed, the test result is invalid and the sample needs to be re-tested.

Cross-reaction: no cross-reaction with influenza A virus, influenza B virus, adenovirus, coxsackie virus, ECHO virus, enterovirus; no cross-reaction with Chlamydia pneumoniae, Mycoplasma pneumoniae, Chlamydia psittaci and Chlamydia trachomatis; Abalone Acinetobacter mantis, Bordetella pertussis, Candida albicans, Escherichia coli, Haemophilus influenzae and Neisseria gonorrhoeae do not cross-react.