|
Product Details:
|
| Product Name: | PocRoc® Monkeypox Virus IgM/IgG Antibody Rapid Test Kit (Colloidal Gold) | Function: | Detection Of Monkeypox Virus IgM/IgG Antibody |
|---|---|---|---|
| Application: | IVD Professional Test In Hospital Clinic Laboratory | Format: | Cassette |
| Specimen: | Whole Blood /Serum/Plasma | Storing Temperature: | 4℃-30℃ |
| Shelf Life: | 24 Months | Sensitivity: | 93.33% |
| Specificity: | 99.16% | ||
| Highlight: | CE Registered IgM IgG Test Kit,Monkeypox Virus IgM IgG Test Kit,CE Registered Antibody Rapid Test Kit |
||
PocRoc® Monkeypox Virus IgM/IgG Antibody Rapid Test Kit (Colloidal Gold) CE Registered
PocRoc® Monkeypox Virus IgM/IgG Antibody Rapid Test Kit (Colloidal Gold)
Summary
Monkeypox virus is a member of the Orthopoxvirus genus, including variola (smallpox) virus, vaccinia (the smallpox vaccine) virus, cowpox virus, and camelpox virus[1].
Monkeypox is a rare disease caused by infection with the monkeypox virus and can be spread from person to person through direct contact with infectious rash, scabs, or body fluids. It also can be spread by respiratory secretions during prolonged, face-to-face contact, or during intimate physical contact[2]. Endemic monkeypox is generally self-limited, with clade-dependent case fatality rates of 1-10%. The monkeypox virus typically incubates for 7-14 days before symptoms appear, symptoms include fever, headache, muscle aches, and swollen lymph nodes, followed by a rash[3].
During the presence of an acute-phase induction against monkeypox virus, detection of both anti-orthopoxvirus IgG and IgM reactivity within the first week after rash onset was observed in both vaccinated and nonvaccinated cases. Positive IgG titers appeared as early as day 1 and day 2 after rash onset and until day 147 and day 139 in vaccinated and unvaccinated cases, respectively. Positive IgM titers were observed as early as day 2 after rash onset in both vaccinated and unvaccinated cases, Positive IgM titers were observed out to day 126 in unvaccinated cases, while vaccinated cases had detectable titers out to day 77[4].
Intended Use
The PocRoc® Monkeypox Virus IgM/IgG Antibody Rapid Test Kit (Colloidal Gold) is intended for in vitro qualitative detection and differentiation of anti-Monkeypox Virus IgM and IgG antibodies in human serum/plasma/whole blood samples (including venous blood and fingertip blood) from patients suspected of Monkeypox Virus infection.
For in vitro diagnostic use only.
| REF No | Package | Cassette | Sample Buffer | Pipette | Lancet | IFU |
| C3107-001 | 1 test / box | 1 | 1 | 1 | 1 | 1 |
| C3107-005 | 5 tests / box | 5 | 5 | 5 | 5 | 1 |
| C3107-010 | 10 tests / box | 10 | 10 | 10 | 10 | 1 |
| C3107-025 | 25 tests / box | 25 | 25 | 25 | 25 | 1 |
| C3107-050 | 50 tests / box | 50 | 50 | 50 | 50 | 1 |
IgM IgG Antibody Rapid Test Kits Features&Advantage:
Warnings and Precautions
1. For In vitro diagnostic use only and for medical professional use only
2. Read the package leaflet carefully and follow all instructions strictly. The reliability of the test results cannot be guaranteed if the user does not follow the instructions in this package leaflet exactly.
3. Do not use the test kit beyond the expiration date printed on the packing box.
4. Different batches of sample buffers and test strips cannot be mixed.
5. The test is for single-use only. Do not re-use in any circumstances.
6. Follow your clinical and/or laboratory safety guidelines in the collection, handling, storage, and disposal of patient samples and all items exposed to patient samples.
7. The best test temperature is 20°C ~ 30°C and humidity RH is 40% ~ 60%.
8. Allow the test kit and specimen to equilibrate to room temperature (15-30°C) prior to testing.
9. Follow the storage recommendations listed on the product labels. Improper storage may adversely affect the product.
10. It is not recommended to run the test on blood samples with visible hemolysis.
Contact Person: Bonnie
Tel: 86-13814877381
