Malaria pf/pan testing device
Introduction:
The Malaria Pf/Pan Test Device is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of Plasmodium falciparum (Pf) antigen and P. vivax, P. ovale, or P. malariae antigen in human blood specimen. The test is for professional in vitro diagnostic use only.
Principle:
The Malaria Pf/Pan Test Device is a lateral flow chromatographic immunoassay. The test components consist of: 1) a burgundy colored conjugate pad containing mouse anti- pHRP-II antibody conjugated with colloid gold (pHRP II-gold conjugates) and mouse anti-pLDH antibody conjugated with colloid gold (pLDH-gold conjugates), 2) a nitrocellulose membrane strip containing two test bands (T1 and T2 bands) and a control band (C band). T1 band is pre-coated with monoclonal anti-pLDH antibody by which the infection with any of the four species of plasmodia can be detected, the T2 band is precoated with polyclonal anti-pHRP-II antibodies for the detection of Pf infection, and the C band is coated with goat anti-mouse IgG.
During the assay, an adequate volume of the blood specimen is dispensed into the sample well (S) of the test cassette, a lysis buffer is added to the buffer well (B). The buffer contains a detergent that lyses the red blood cells and releases various plasmodium antigens, which migrate by capillary action across the strip held in the cassette. pHRP-II if presents in the specimen will bind to the pHRP II-gold conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-pHRP-II antibodies, forming a burgundy colored T2 band, indicating a Pf positive test result.
pLDH if presents in the specimen will bind to the pLDH gold conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti pLDH antibody, forming a burgundy colored T1 band, indicating a plasmodium positive test result. In the absence of T2 band, a positive test result for any of the other three plasmodia can be recommended.
Absence of any T bands (T1 and T2) suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti-mouse IgG /mouse IgG (pHRP-II and pLDH-gold conjugates) regardless of the color development on any of the T bands. Otherwise, the test result is invalid and the specimen must be retested with another device
Product Feature:
- Instant screening test
- Detects infections caused by any of the four malaria parasite species
- Differentiates the infection of Pf from the other three species in one single test
- Short testing time, results are available in 20 minutes
- Visual results, easy interpretation
- Suitable for people having not bulit protective immunity in 30 regions with low malaria incidence(Latin America and Asia)
Materials Supplied:
Each test contains :
1. One cassette device
2. One pipette dropper
3. One desiccant
Indicators of malaria test kit:
- Features: high sensitivity, simple & easy to use and the result is accurate .
- model number: cassette(3.0mm 4.0mm)
- Read Time: 5-10minutes
- Accuracy: >99%
- Packing details:25 or 40T/box,2000T/ctn; 50T/box, 2500T/ctn; 100T/bag,2000T/ctn
Product
Function | used for early diagnosis of malaria(pv/pf) |
Formats | cassette |
Specifications | cassette(3mm, 4mm) according to the customers' requirements |
Specimens | serum |
Sensitivity | 10mIU/ml, 15 mIU/ml, 20 mIU/ml, 25mIU/ml |
Specificity | over 99.6% |
Shelf Life | 24 months at room temperature |
Packing Details | Cassette 40pcs/bag, 50bags/carton. 500,000pcs/20'ft container 40pcs/box, 50boxes/carton, 550,000pcs/20’ft container 1pcs/box, 500boxes/carton, 120,000pcs/20’ft container |
Others | The kits can be made according to the customers' artwork or design |
Product pictures:
