Malaria HRP2/pLDH (P.fP.v) Antigen Rapid Test Kit (Lateral chromatography)

Short Description:

Specimen	Whole Blood/Fingertip Blood	Format	Cassette
Trans. & Sto. Temp.	2-30℃ / 36-86℉	Test Time	20 mins
Specification	1 Test/Kit; 25 Tests/Kit

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Product Detail

Product Tags

Product details

Intended Use
Malaria antigen detection kit is designed as a simple, rapid, qualitative and cost effective method for the simultaneous detection and differentiation of Plasmodium falciparum (P.f) and Plasmodium vivax (P.v) in human whole blood or fingertip whole blood. This device is intended to be used as a screening test and used for the auxiliary diagnosis of P. f and P.v infection.

Test Principle
The Malaria antigen test kit (Lateral chromatography) is based on the principle of microsphere double antibody sandwich method to rapid qualitative determination of P.f/ P.v antigen in human whole blood or fingertip whole blood. The microsphere is marked in anti-HRP-2 antibody (specific to P.f) on the T1 band and anti-PLDH antibody(specific to P.v) on the T2 band, and anti-mouse IgG polyclonal antibody is coated on quality control area (C). When the sample contains malaria HRP2 or pLDH antigen and the concentration is higher than the minimum detection limit, which are allowed to react with the colloidal microsphere coated with Mal-antibody to form antibody-antigen complex. The complex then moves laterally on the membrane and respectively binds to the antibody immobilized on the membrane producing a pink line on the test region, which indicates a positive result. The presence of the control line demonstrates the test has been performed correctly regardless the presence of P.f/ P.v antigen.

Main Contents

Components provided are listed in the table.

ComponentREF	B013C-01	B013C-25
Test Cassette	1 test	25 tests
Sample Diluent	1 bottle	1 bottle
Dropper	1 piece	25 PCS
Instructions For Use	1 piece	1 piece
Certificate of Conformity	1 piece	1 piece

Operation Flow

Step 1: Sampling

Collect human whole blood or fingertip 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. Put it on the horizontal plane.
2. Open the inspection card aluminum foil bag. Remove the test card and place it horizontally on a table.
3. Add 60μL sample dilution solution immediately. Start counting.

Step 3: Reading

20 mins later, read the results visually. (Note: do NOT read the results after 30 minutes!)

Result Interpretation

1.P.f Positive
The presence of two colored bands ("T1" and "C") within the result window indicates P.f Positive.
2.P.v Positive
The presence of two colored bands ("T2"and "C") within the result window indicates P.v.
3.Positive. P.f and P.v Positive
The presence of three colored bands ("T1","T2"and "C") within the result window may indicates mixed infection of P. f and Pan.
4.Negative Result
The presence of only control line(C) within the result window indicates a negative result.
5.Invalid Result
If no band appears in the control region(C), the test results are invalid regardless of the presence or absence of line in the test region(T). The direction may not have been followed correctly or the test may have deteriorated It is recommended that repeat the test using a new device.

Order Information

Product Name	Cat. No	Size	Specimen	Shelf Life	Trans. & Sto. Temp.
Malaria HRP2/pLDH (P.f/P.v) Antigen Rapid Test Kit (Lateral chromatography)	B013C-01	1test/kit	Whole Blood/Fingertip Blood	18 Months	2-30℃ / 36-86℉
	B013C-25	25 tests/kit	Whole Blood/Fingertip Blood	18 Months	2-30℃ / 36-86℉