Tuberculosis Antibody Test Kit (Immunochromatographic Assay)

Short Description:

Specimen	Serum/Plasma/Whole Blood	Format	Cassette
Sensitivity	98.34%	Specificity	97.93%
Trans. & Sto. Temp.	2-30℃ / 36-86℉	Test Time	5-10 mins
Specification	1 Test/Kit 5 Tests/Kit 25 Tests/Kit

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Product Detail

Product Tags

Product details

Intended Use
This product is suitable for the qualitative clinical screening of serum/plasma/whole blood samples for the detection of antibodies against Mycobacterium tuberculosis. It is a simple, rapid and non-instrumental test for the diagnosis of tuberculosis caused by Mycobacterium tuberculosis.

Test Principle
Tuberculosis Antibody Test Kit (Immunochromatographic Assay) is a lateral flow chromatographic immunoassay. It has two pre-coated lines, “T” Test line and “C” Control line on the nitrocellulose membrane.
The purified specific recombinant Mycobacterium tuberculosis antigen is immobilized on the nitrocellulose membrane at the Test Line region and another specific Mycobacterium tuberculosis Ag conjugated to the colloidal gold is coupled on the label pad.

Main Contents

Components provided are listed in the table.

Materials / provided	Quantity(1 Test/Kit)	Quantity(5 Tests/Kit)	Quantity(25 Tests/Kit)
Test Kit	1 test	5 tests	25 tests
Buffer	1 bottle	5 bottles	25/2 bottles
Dropper	1 piece	5 piece	25 piece
Specimen Transport Bag	1 piece	5 pcs	25 pcs
Disposable Lancet	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

Collect human Serum/Plasma/Whole blood properly.

Step 2: Testing

1. Remove an extraction tube from the kit and a test box from the film bag
by tearing the notch. Open the inspection card aluminum foil bag. Remove the test card and
place them horizontally on a platform.
2. Use a disposable pipette, transfer 4μL serum (or plasma), or 4μL whole blood into the sample well on the test cassette.
3. Open the buffer tube by twisting off the top. Put 3 drops (about 80 μL) of assay diluent into the assay diluent well round shaped. Start counting.

Step 3: Reading

Read the result at 5-10min. Results after 10 minutes are invalid.

Result Interpretation

Negative result
Only the quality control C line appears and the detection T line does not show color, it indicates that there is no TB antibody in the specimen.

Positive Result
Both the quality control C line and the detection T line appear, and the
result is positive for TB antibody.

Invalid Result
No visible colored band appears at control line after performing the test.
Review the test procedure and repeat the test using a new test device.

Order Information

Product Name	Cat. No	Size	Specimen	Shelf Life	Trans. & Sto. Temp.
Tuberculosis Antibody Test Kit (Immunochromatographic Assay))	B022C-01	1test/kit	Serum/Plasma/Whole Blood	18 Months	2-30℃ / 36-86℉
	B022C-05	5 tests/kit
	B022C-25	25 tests/kit