Evolve Medical
INTENDED USE: The Dengue Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Dengue virus in human whole blood, serum, or plasma as an aid in the diagnosis of primary and secondary Dengue infections.
| Storage | 2~30 º C |
| Specimen | Whole Blood/Serum/Plasma |
| Component | Rapid Test + Buffer + Pipettes |
| Principle | Colloidal gold rapid tests |
| Reading Time | Within 15 mins |
| Package | 40tests/box |
| Origin | China |
Dengue is a flavivirus, transmitted by Aedes aegypti and Aedes albopictus mosquitoes. It is widely distributed throughout the tropical and subtropical areas of the world and causes up to 100 million infections annually. Classic Dengue infection is characterized by a sudden onset of fever, intense headache, myalgia, arthralgia and rash.
Primary Dengue infection causes IgM antibodies to increase to a detectable level in 3 to 5 days after the onset of fever. Most Dengue patients in endemic regions have secondary infections, resulting in high levels of specific IgG antibodies prior to or simultaneous with IgM response. The detection of specific anti-Dengue IgM and IgG antibodies helps distinguish between primary and secondary infections.
STORAGE AND STABILITY: Store at 2 ~ 30 º C in the sealed pouch for 24 months.
PRECAUTIONS:
1. Bring the pouch to room temperature before opening. Remove the test device and use it as soon as possible.
2. Place the test device on a clean and level surface.
3. For Serum/Plasma: Transfer specimen to well (S) (approx. 5 uL), add 3 drops of buffer (approx. 90 mL) and start timer.
4. For Whole Blood: Transfer 1 drop (approx. 10 µL) to well (S), add 3 drops of buffer (approx. 90 uL) and start timer.
5. Wait for colored lines to appear. Read results at 10 minutes. Do not interpret after 20 minutes.
POSITIVE: Two colored bands appear on the membrane. One in the control region (C) and another in the test region (T).
NEGATIVE: Only one colored band appears in the control region (C). No band in the test region (T).
INVALID: Control band fails to appear. Review the procedure and repeat with a new test.
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