Mononucleosis Rapid Test
This Mononucleosis Rapid Test is a high-sensitivity immunoassay designed for the visual, qualitative detection of heterophile antibodies specific to Infectious Mononucleosis (IM). Validated for use with human serum, plasma, or whole blood, this assay serves as a critical diagnostic aid for patients presenting with characteristic clinical symptoms. Engineered for professional laboratory use, it provides essential analytical data to support physician-led disease management.
Characteristics
Clinical Accuracy & Performance Validation:The diagnostic precision of this Mononucleosis Rapid Test was rigorously evaluated through a comparative study involving 406 clinical specimens (comprising 288 serum, 103 plasma, and 15 whole blood samples). Tested against a leading commercially available color immuno-chromatographic assay, the kit demonstrated exceptional correlation in the qualitative detection of IM-specific IgM heterophile antibodies, ensuring reliable performance across all validated sample matrices.
Specifications
Item | Value |
| Product name | Mononucleosis 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 |
| Safety standard | None |
| Specimen | human serum, plasma or whole blood. |
| 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 Mononucleosis Rapid Test used for?
It is a qualitative lateral flow immunoassay for the visual detection of heterophile antibodies specific to Infectious Mononucleosis (IM).
2. Which specimen types are compatible with the IM rapid test?
The test is validated for use with human whole blood, serum, and plasma, providing flexible options for clinical laboratories.
3. What is the significance of heterophile antibodies in IM diagnosis?
Heterophile antibodies are a primary marker for Infectious Mononucleosis; their detection helps physicians confirm IM in symptomatic patients.
4. Is this Mononucleosis test kit intended for home use?
No, this kit is designed for professional laboratory use and in vitro diagnostic (IVD) applications only.
5. How was the accuracy of this Mononucleosis test validated?
The accuracy was evaluated through a comparison study of 406 human samples against a commercially available color immuno-chromatographic assay.
6. How many serum and plasma samples were included in the clinical study?
The study included 288 serum samples, 103 plasma samples, and 15 whole blood samples to ensure broad diagnostic reliability.
7. Does the test detect IM-specific IgM antibodies?
Yes, the test is specifically designed to identify IM IgM heterophile antibodies produced during the infection.
8. How long does it take to interpret the test results?
As a rapid diagnostic test (RDT), it provides clear visual results within minutes, supporting efficient patient management.
9. What is the shelf life of the Mononucleosis test cassette?
The kit offers a stable shelf life of 2 years (24 months) from the manufacturing date when stored correctly.
10. What quality certifications does this diagnostic kit have?
The product is CE approved and manufactured under ISO9001 and ISO13485 international quality management systems.
11. Does the kit require specialized equipment or a power source?
No, this is a manual test that does not require instrumentation, making it ideal for various clinical settings.
12. What are the available packaging configurations for international orders?
We offer flexible packaging including 1, 25, 50, or 100 tests per box, with individual foil bag protection for each cassette.
13. Is OEM manufacturing available for this IM kit?
Yes, we provide full OEM and private labeling services to meet the specific branding needs of global distributors.
14. What is the instrument classification for this test kit?
It is classified as a Class II medical instrument, ensuring it meets rigorous safety and performance standards.
15. How should the IM test results be interpreted?
A positive result is indicated by the appearance of distinct colored lines in both the Control (C) and Test (T) regions.
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