Leishmania IgG/IgM Antibody Test Kit (Immunochromatographic Assay)

Short Description:

Specimen	Serum/Plasma/Whole Blood	Format	Cassette
Sensitivity	98.83%	Specificity	98.02%
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 Leishmania. It is a simple, rapid and non-instrumental test for the diagnosis of kala-azar caused by Leishmania.

Test Principle
This product is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing recombinant rK39 antigen conjugated with colloid gold (Leishmania conjugates) and rabbit IgG-gold conjugates; 2) a nitrocellulose membrane strip containing two test bands (M and G bands) and a control band (C band).

Main Contents

Components provided are listed in the table.

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

Please read the instructions carefully before testing. Before testing, allow the test kit, sample solution and sample to be balanced to temperature (15-30℃or 59-86 degrees Fahrenheit).
1.Remove an extraction tube from the kit and a test box from the film bag by tearing the notch. Put them on the horizontal plane.
2.Open the inspection card aluminum foil bag. Remove the test card and place it horizontally on a table.
3.Use a disposable pipette, transfer one drop (about 20μL) fingertip blood/or 4μL serum /or 4μL plasma/ or 4μL whole blood into the sample well on the test cassette.
4.Open the buffer tube. 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 5-10 mins. Results after 10 minutes are invalid.

Result Interpretation

Negative result
If only the quality control line C appears and the detection lines G and M do not show

Positive Result
1.Both the quality control line C and the detection line M appear= the Leishmania IgM antibody is detected, and the result is positive for the IgM antibody.
2.Both the quality control line C and the detection line G appear= the Leishmania IgG antibody is detected and the result is positive for the IgG antibody.
3.Both the quality control line C and the detection lines G and M appear=the Leishmania IgG and IgM antibodies. are detected, and the result is positive for both IgG and IgM antibodies.

Invalid Result
The quality control line C cannot be observed, results will be invalid regardless of whether a test line shows, and the test should be repeated.

Order Information

Product Name	Cat. No	Size	Specimen	Shelf Life	Trans. & Sto. Temp.
Leishmania IgG/IgM Antibody Test Kit (Immunochromatographic Assay)	B020C-01	1test/kit	Serum/Plasma/Whole Blood	18 Months	2-30℃ / 36-86℉
	B020C-05	5 tests/kit
	B020C-25	25 tests/kit