HEV IgG/IgM Test Kit
(Serum / Plasma/ Whole Blood)
The HEV IgG/IgM test kit (serum / plasma/ whole blood) is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis E IgG/IgM antibody in whole blood,serum or plasma.
Material provided
1.Individual sealed pouches, each containing:
Test device
Desiccant pouch
Extraction tubes
2.Extraction buffer in a dropper bottle (6mL): 0.01M
phosphate buffer saline (PBS).
3.Instruction for Use
Qualitative detection of hepatitis E virus IgG/IgM antibodies in human serum/plasma/whole blood for clinical auxiliary diagnosis. Hepatitis E (HE) is an acute infectious hepatitis caused by the Hepatitis E virus (HEV). It is mainly transmitted through contaminated water sources and can also be transmitted through food and daily oral contact. Previously known as intestinal transmission of non A, non B hepatitis, it often causes outbreaks or epidemics, but can also be sporadic. The mortality rate is about 0.5%~1.5%, slightly higher than hepatitis A, but the mortality rate of hepatitis E in pregnant women can be as high as 20%. China is one of the high
prevalence areas of hepatitis E, accounting for approximately 10% -20% of clinical sporadic hepatitis cases. HEV has four genotypes, with genotype 1 being an epidemic strain in developing countries in Asia and Africa;Genotype 2 is distributed in Mexico and some African countries; Gene type 3 is widely distributed globally and has been detected in patients with sporadic acute hepatitis in many countries except for Africa; The genotype 4 analyzer has been detected in the human body of Asian countries. The HEV in China is mainly genotype 1, with some being genotype 4
Product Features
1.Easy handling, no instrument required.
2. Results at 15 minutes.
3. Results are clearly visible and reliable.
4. High Accuracy.
5. Room temperature storage.
TEST PROCEDURE
1.Allow the test kit, specimen, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
2. Remove the test kit from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
3. Place the test device on a clean and level surface.Hold the dropper vertically. Transfer about 1 drop of specimen(about 5ul) to the sample well of the test device;then add 2 drops of buffer (about 80ul).
4. Wait for the red line(s) to appear. The result should be read within 10 minutes. Do not read the results after 20 minutes.To avoid confusion,discard the test device after interpreting the result
