China SARS-CoV-2 & Influenza A/B Antigen Combo Rapid test kit (Lateral chromatography) factory and manufacturers

Product Details

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Product details

Intended Use

SARS-CoV-2 and Influenza A/B Virus Antigen Rapid Test Kit (Lateralchromatography) is suitable for qualitative detection of SARS-CoV-2 antigen, influenza A virus antigen, and influenza B virus antigen in human nasopharyngeal swab or oropharyngeal swab samples.

For In Vitro Diagnostic use only.

Test Principle

SARS-CoV-2 and Influenza A/B Virus Antigen Rapid Test Kit is based on immunochromatographic assay to detect SARS-CoV-2 antigens, influenza A virus antigens and influenza B virus antigens in human nasopharyngeal swab or oropharyngeal swab samples. During the test, SARS-CoV-2 antigens, influenza A virus antigens and influenza B virus antigens conjugate with SARS-CoV-2 antibodies, influenza A virus antibodies and influenza B virus antibodies labeled on colored spherical particles to form immune complex. Owing to capillary action, immune complex flow across the membrane. If the sample contains SARS-CoV-2 antigens, influenza A virus antigens or influenza B virus antigens, it will be captured by the pre-coated test area and form visible test line.

To serve as a procedure control, a colored control line will appear if the test has been performed properly.

Main Contents

Components provided are listed in the table.

Cat. No	B005C-01	B005C-25
Materials / provided	Quantity(1 Test/Kit)	Quantity(25 Tests/Kit)
Test Cassette	1 piece	25 pcs
Disposable Swabs	1 piece	25 pcs
Sample Extraction Solution	1 bottle	25/2 bottles
Biohazard Disposal Bag	1 piece	25 pcs
Instructionsfor Use	1 piece	1 piece
Certificate of Conformity	1 piece	1 piece

Operation Flow

Step 1: Sampling

Sample collection: Collect nasopharyngeal swab or oropharyngeal swab samples according to the method of sample collection.

Step 2: Testing

1. Remove the cap from extraction solution tube.

2. Insert the sample swab into the tube (immerse the sample part in the sample extraction solution), make sure the sample is removed into the

extraction solution by rubbing and stirring the sampled swab up & down for 5 times.

3. Squeeze the tube and the swab 5 times to leave the extraction solution on the swab completely in the extraction solution tube.

4. Take out the test cassette from the aluminum foil bag and place it on a horizontal and dry plane.

5. Mix the sample by gently turning the tube upside down, squeeze the tube to add 3 drops (about 100μL) to the sample well of the test cassette, and

start counting.

6. Visually read the result after 15-20 minutes. The result is invalid after 20 minutes.

Step 3: Reading

15 mins later, read the results visually. (Note: do NOT read the results after 20 mins!)

Result Interpretation

1.SARS-CoV-2 Positive Result

Colored bands appear at both test line (T) and control line (C). It indicates a

positive result for the SARS-CoV-2 antigens in the specimen.

2.FluA Positive Result

Colored bands appear at both test line (T1) and control line (C). It indicatesa

positive result for the FluA antigens in the specimen.

3.FluB Positive Result

Colored bands appear at both test line (T2) and control line (C). It indicatesa

positive result for the FluB antigens in the specimen.

4.Negative Result

Colored band appear at control line (C) only. It indicates that the

concentration of the SARS-CoV-2 and FluA/FluB antigens do not exist or

below the detection limit of the test.

5.Invalid Result

No visible colored band appears at control line after performing the test. The

directions may not have been followed correctly or the test may have

deteriorated. It is recommended that the specimen be re-tested.

Order Information

Product Name	Cat. No	Size	Specimen	Shelf Life	Trans. & Sto. Temp.
SARS-CoV-2 & Influenza A/B Antigen Combo Rapid test kit (Lateral chromatography)	B005C-01	1test/kit	Nasalpharyngeal Swab, Oropharyngeal Swab	18 Months	2-30℃ / 36-86℉
	B005C-25	25 tests/kit	Nasalpharyngeal Swab, Oropharyngeal Swab	18 Months	2-30℃ / 36-86℉

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SARS-CoV-2 & Influenza A/B Antigen Combo Rapid test kit (Lateral chromatography)

Introduction