Leishmania IgG/IgM Ab Combo Rapid Tes
This Leishmania IgG/IgM Ab Combo Rapid Test is a high-performance lateral flow immunoassay engineered for the simultaneous detection and differentiation of IgG and IgM antibodies. It targets specific antigens of Leishmania donovani, the primary causative protozoan of Visceral Leishmaniasis. Compatible with human whole blood, serum, or plasma, this assay serves as a robust screening tool and a critical diagnostic aid, providing clinically relevant data for infection stage assessment.
Characteristics
Looking for a high-accuracy Leishmania test? Our CE-marked IgG/IgM Combo Kit has been clinically validated with a 99.6% specificity and 91% sensitivity for IgM detection. With an overall agreement of 98.5%, this rapid diagnostic tool is optimized for identifying Leishmania donovani in whole blood or serum, making it an essential asset for infectious disease surveillance and professional medical screening.
Specifications
Item | Value |
| Product name | Leishmania IgG/IgM Ab Combo Rapid Test |
| Power Source | Manual |
| Warranty | 2 years |
| After-sale Service | Online technical support |
| Material | Plastic, paper |
| Shelf Life | 2 years |
| Quality Certification | ISO9001, ISO13485 |
| Instrument classification | Class II |
| Specimen | human whole blood, serum or plasma.. |
| Sample | Available |
| Format | Cassete |
| Certificate | CE Approved |
| OEM | Available |
| Package | 1pc/box, 25pcs/box, 50 pcs/box, 100pcs/box, customized |
Packaging & delivery
Packaging: 1pc/box; 25pcs/box, 50 pcs/box, 100pcs/box, individual aluminium foil bag package for each piece product; OEM packing is available.
Port: any ports of China, optional.
FAQs:
1. What is the Leishmania IgG/IgM Ab Combo Rapid Test?
It is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM antibodies to Leishmania donovani.
2. Which subspecies of Leishmania does this test detect?
The test is specifically designed to detect antibodies to the subspecies of Leishmania donovani (L. donovani), the causative protozoans of Visceral leishmaniasis.
3. What is the clinical sensitivity of the Leishmania IgM test?
Based on clinical performance studies, the IgM test shows a relative sensitivity of 91% in fresh infected patients.
4. What is the specificity of this Leishmania rapid diagnostic kit?
The test boasts a high relative specificity of 99.6%, ensuring minimal false-positive results in non-infected individuals.
5. What specimen types can be used for the Leishmania assay?
This rapid test is compatible with human whole blood, serum, or plasma specimens.
6. How long is the results interpretation time?
As a rapid diagnostic test, it provides clear visual results within minutes, facilitating quick screening for Visceral leishmaniasis.
7. Is this test kit CE and ISO certified?
Yes, the product is CE approved and manufactured under ISO9001 and ISO13485 quality management systems.
8. Does the test require laboratory equipment?
No, this is a manual, equipment-free diagnostic kit that can be used in both clinical and field settings.
9. What is the shelf life of the Leishmania test cassette?
The kit has a stable shelf life of 2 years (24 months) when stored in its original sealed packaging.
10. What is the overall agreement rate of this test?
In clinical evaluations, the Leishmania IgG/IgM Ab Combo Rapid Test demonstrated an overall agreement of 98.5%.
11. Can this test differentiate between acute and chronic infections?
Yes, by detecting both IgG and IgM antibodies, it helps differentiate between different stages of Leishmania infection.
12. What are the packaging options for international shipping?
Standard packs include 25, 50, or 100 tests per box, each individually sealed in aluminum foil bags.
13. Is OEM service available for bulk orders?
Yes, we provide OEM packaging and private labeling services for global medical distributors.
14. What should be done with a reactive specimen?
Any reactive or positive specimen must be confirmed with alternative clinical testing methods for a final diagnosis.
15. What is the instrument classification for this kit?
It is classified as a Class II medical instrument, intended for professional in vitro diagnostic (IVD) use.
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