Testsea Disease Test Malaria Ag p.f/p.v Tri-line Test

Short Description:

Purpose:
This test provides a rapid and reliable method to diagnose malaria infection caused by Plasmodium falciparum and Plasmodium vivax. It detects specific malaria antigens (such as HRP-2 for P.f. and pLDH for P.v.) that are present in the blood during active infection.

Key Features:

Tri-line Design:
- This test is capable of detecting both Plasmodium falciparum (P.f.) and Plasmodium vivax (P.v.) infections, with separate lines for each species and a control line for quality assurance.
Rapid Results:
- Results are available in just 15-20 minutes, making it suitable for field use and point-of-care diagnosis in areas with limited access to laboratory facilities.
High Sensitivity and Specificity:
- The test is designed for high sensitivity and specificity in detecting malaria antigens, providing accurate results to aid in the clinical management of malaria.
Easy to Use:
- The test requires minimal training to perform and is suitable for use in remote areas or resource-limited settings.

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Product Detail

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Product Detail:

Sample Type:
- Whole blood (fingerstick or venipuncture blood sample).
Detection Time:
- 15-20 minutes (results should be interpreted within 20 minutes; results after this period are invalid).
Sensitivity and Specificity:
- Sensitivity: Typically > 90% for detecting both P.f. and P.v. infections.
- Specificity: Typically > 95% for both P.f. and P.v. detection.
Storage Conditions:
- Store between 4°C and 30°C, away from direct sunlight.
- Do not freeze.
- Shelf life typically ranges from 12 to 24 months, depending on the manufacturer's instructions.
Result Interpretation:
- Positive Result:
  - Three lines visible:
    1. C (Control) line (indicates the test is valid).
    2. P.f. line (if Plasmodium falciparum antigens are detected).
    3. P.v. line (if Plasmodium vivax antigens are detected).
    - The presence of the P.f. and/or P.v. lines indicates infection with the respective species of malaria.

Principle:

Immunochromatographic Assay:
The test cassette contains immobilized monoclonal antibodies specific for Plasmodium antigens (e.g., HRP-2 for P.f. and pLDH for P.v.).

When blood is applied to the test, if malaria antigens are present, they will bind to the gold-conjugated antibodies in the sample, which will move along the test membrane by capillary action.
If the Plasmodium falciparum antigen is detected, a colored line will form at the P.f. line.
If the Plasmodium vivax antigen is detected, a colored line will form at the P.v. line.
The Control line (C) ensures the test is functioning properly and indicates the validity of the test.

Composition:

Composition	Amount	Specification
IFU	1	/
Test cassette	25	Each sealed foil pouch containing one test device and one desiccant
Extraction diluent	500μL1 Tube 25	Tris-Cl buffer, NaCl, NP 40, ProClin 300
Dropper tip	1	/
Swab	/	/

Test Procedure:


1. Wash your hands	2. Check the kit contents before testing,include package insert, test cassette, buffer, swab.	3.Place the extraction tube in the workstation.	4.Peel off aluminum foil seal from the top of the extraction tube containing the extraction buffer.

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5.Carefully remove the swab without touching the tip.Insert the entire tip of the swab 2 to 3 cm into the right nostril.Note the breaking point of the nasal swab.You can feel this with your fingers when inserting the nasal swab or check it in the mimnor. Rub the inside of the nostril in circular movements 5 times for at least 15 seconds,Now take the same nasal swab and insert it into the other nostril.Swab the inside of the nostril in a circular motion 5 times for at least 15 seconds. Please perform the test directly with the sample and do not
leave it standing.

6.Place the swab in the extraction tube.Rotate the swab for about 10 seconds,Rotate the swab against the extraction tube,pressing the head of the swab against the inside of the tube while squeezing the sides of the tube to release as much liquid as possible from the swab.


7. Take out the swab from the package without touching the padding.	8.Mix thoroughly by flicking the bottom of the tube.Place 3 drops of the sample vertically into the sample well of the test cassette.Read the result after 15 minutes. Note:Read the result within 20 minutes.Otherwise,are petition of the test is recommended.

Results Interpretation: