SARS-CoV-2 Saliva Antigen Rapid Detection Kit (Latex Chromatography)

Short Description:

Specimen	Saliva	Format	Cassette
Sensitivity	96.23%	Specificity	97.94%
Trans. & Sto. Temp.	2-30℃ / 36-86℉	Test Time	15 mins
Specification	1 Test/Kit; 5 Tests/Kit; 25 Tests/Kit

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Product Detail

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Product Tags

Intended Use
SARS-CoV-2 Saliva Antigen Rapid Detection Kit (Latex Chromatography) is to be used in conjunction with clinical manifestations and other laboratory test results to assist in the diagnosis of patients with suspected SARS-CoV-2 infection. The test
is only to be used by medical professionals. It provides only an initial screening test result and more specific alternative diagnosis methods should be performed in order to obtain the confirmation of SARS-CoV-2 infection. for professional use only.

Test Principle
It is a lateral flow assay that qualitatively detects the presence of nucleocapsid (N) protein in upper respiratory samples. This lateral flow assay is designed with the Double-antibody sandwich immunoassay format.

Main Contents

Components provided are listed in the table.

Component/REF	XGKY-002	XGKY-002-5	XGKY-002-25
Test Cassette	1 test	5 tests	25 tests
Disposable paper cups	1 piece	5 pcs	25 pcs
Sample Lysis Solution	1 tube	5 tubes	25 tubes
Specimen Transport Bag	1 piece	5 pcs	25 pcs
Instructions For Use	1 piece	1 piece	1 piece
Certificate of Conformity	1 piece	1 piece	1 piece

Operation Flow

Step 1: Sampling

1. Open the container. Make a “Kruuua” noise from the throat to clear the saliva from deep throat, then spit saliva (about 2 ml) into the container. Avoid any saliva contamination of the outer surface of the container.
2. Optimal timing of specimen collection：After getting up and before brushing teeth, eating or drinking.

Step 2: Testing

1 Take an extraction tube from the kit and remove a test cassette from the foil pouch by tearing at the notch. Place them on a level surface.
2 Take 200μL fresh saliva samples with a disposable dropper (The absorbed saliva rises to the first scale of disposable dropper) from container.
3 Transfer the saliva samples into the Extraction Tube and shake and mix it.
4 Firmly attach dropper lid to the top of the extraction tube. Then gently invert the extraction tube 5 times.
5 Transfer 3 drops (about 100μL) specimen to the sample well and start counting. Note: If using a frozen sample, the sample must be at room temperature before testing.

Step 3: Reading

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

Result Interpretation

Positive Result
Colored bands appear at both test line (T) and control line (C). It indicates apositive result for the SARS-CoV-2 antigens in the specimen.

Negative Result
Colored band appear at control line (C) only. It indicates that the concentration of the SARS-CoV-2 antigens does not exist or below the detection limit of the test.

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 Saliva Antigen Rapid Detection kit (Latex Chromatography)	XGKY-002	1test/kit	Saliva	18 Months	2-30℃ / 36-86℉
	XGKY-002-5	5 tests/kit
	XGKY-002-25	25 tests/kit