Rapid Test Kit SARS-CoV-2 Antigen & Influenza A/B Rapid Test Kit Professional Detection Rapid Test Kit

Intended Use

The SARS-CoV-2 Antigen & Influenza A/B Rapid Test Kit (Immunochromatography) is a lateral flow chromatography immunoassay intended for the qualitative detection and differentiation of nucleocapsid protein antigens from SARS-CoV-2, influenza type A and influenza type B in the same time directly from nasal/nasopharyngeal (NS/NP) swab, oropharyngeal (OP) swab and saliva specimens from patients with signs and symptoms of respiratory viral infection. It is for professional use only. The kit is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings. For prescription use only. For in vitro diagnostic use only.

Specification

Main Components

• 20 Test cassettes
• 2 Sample extraction Buffer
• 20 Sample tubes
• 20 Swabs
• 1 Tube Stand
• 1 Instruction Manual

Feature

• High Specificity and Sensitivity
• Safety and Reliability, individual package keep clean
• Simple operation step, one step to do the test
• Fast reacton read the result within15 min

Use Step

• Take out the test cassette from the sealed pouch, place it on a clean and level surface with the sample port well up.

• Apply 2 full drops of the treated sample (60μl-70μl) vertically into each of the two sample wells of the test cassette.

• Observe the test results immediately within 15~20 minutes, the result is invalid over 20 minutes.

Interpretation Of Result

• POSITIVE: The presence of T (T on nCoV /A or B on Flu) and C lines within the reaction window indicate a positive result on SARS-CoV-2 or Flu A and/or B infection or co-infection.

• NEGATIVE: One colored line appears in the control region(C). No apparent colored line appears in the test region (T on nCoV /A or B on Flu). The negative result does not indicate the absence of analytes in the sample, it only indicates the level of tested analytes in the sample is less than the minimum detection limit

• INVALID: No colored lines appear, or control line fails to appear, indicating that the operator error or reagent failure. Verify the test procedure and repeat the test with a new testing device.

PRINCIPLE

• The SARS-CoV-2 Antigen & Influenza A/B Rapid Test Kit employs a lateral flow chromatographic technology to detect the presence of the nucleocapsid protein antigen directly from influenza A, influenza B, and SARS-CoV-2.
• After the patient sample is collected and treated with the antigen extraction buffer, the viral nucleoproteins antigen will be exposed.
• Add the extracted specimen into the test cassette, the specimen will migrate forward along with the test strips through capillary effect.
• If Influenza A, Influenza B, SARS-CoV or SARS-CoV-2 viral antigen is present, they will be captured and detected on the T or A/B line, respectively on each test strips within 15 minutes from the addition of the samples, resulting in purplish red band on the test region, indicating a positive result.
• If the nucleocapsid protein antigen is not present or present at very low levels in the sample, there is no red line appears in “T” or "A/B" positions. The “Control Line” (C) is used for procedural control.
• Control line should always appear if the test procedure is performed properly and the test reagents of control line are working.

Other Information

• This reagent is a qualitative detection reagent, which cannot determine the exact content of antigen.
• The test results of this reagent are only for the reference of clinicians and should not be taken as the sole basis for clinical diagnosis and treatment. Clinical management of patients should be considered in the light of their symptoms/signs, medical history, other laboratory tests and treatment responses.
• Restricted by antigen detection reagent method, the lowest detection limit (sensitivity analysis) is generally lower than that of nucleic acid detection, so the researchers deal with negative result to give more attention, should be combined with other test results comprehensive judgment, advice to doubt the negative result of nucleic acid detection or virus isolation culture identification method for review.