One Step HEV IgG/IgM Rapid Diagnostic Test, to detect antibodies to Hepatitis E virus,Gold colloidal,quickly and easily


Intended Use:

The HEV Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG/IgM) to Hepatitis E virus (HEV) in serum or plasma.

Summary:

Hepatitis E Virus (HEV) is a non-enveloped, single- stranded RNA virus identified in 1990. Infection with HEV induces acute or sub-clinical liver diseases similar to hepatitis A. HEV infections, endemic and frequently epidemic in developing countries, is seen also in developed countries in a sporadic form with or without a history of traveling to endemic area. The overall case-fatality is 0.5~3%, and much higher (15~25%) among pregnant women. A hypothesis that HEV infection is a zoonosis was presented in 1995. Then a swine HEV and later an avian HEV were identified and sequenced separately in 1997 and 2001. Since then, HEV infection include anti-HEV, viremia and feces excretion of HEV was seen in a wide variety of animals, i.e., swine, rodents, wild monkeys, deer, cow, goats, dogs and chicken in both the developing and developed countries. A direct testimony was reported that the consumption of uncooked dear meat infected with HEV led to acute hepatitis E in human. And HEV genome sequences can be detected in pork livers available in the supermarkets in Japan. With the discovery of conformational epitopes in HEV, HEV serology was further explored and understood. The phenomenon of long-lasting and protective antibodies to HEV was observed which greatly enhance the understanding to the diagnosis, epidemiology, zoonosis-related studies and vaccine development.

TEST PRINCIPLE

The HEV Rapid Test Cassette (Serum/Plasma) is a qualitative membrane-based immunoassay for the detection of HEV antibodies in serum or plasma. This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in IgG test line region. During testing, the specimen reacts with HEV antigen-coated particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in IgG test line region. If the specimen contains IgG antibodies to HEV, a colored line will appear in IgG test line region. In the IgM component, anti-human IgM is coated in IgM test line region. During testing, the specimen reacts with anti-human IgM. HEV IgM antibodies, if present in the specimen, reacts with the anti-human IgM and the HEV antigen-coated particles in the test cassette, and this complex is captured by the anti-human IgM, forming a colored line in IgM test line region. Therefore, if the specimen contains HEV IgG antibodies, a colored line will appear in IgG test line region. If the specimen contains HEV IgM antibodies, a colored line will appear in IgM test line region. If the specimen does not contain HEV antibodies, no colored line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.
2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.
3. Use the pipette to draw and slowly add 1 drop of whole blood/serum/plasma to the sample well.
4. Hold the buffer vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2 drops of buffer to the sample well.
5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.

Caution: The above interpreting time is based on room temperature range of 15-30℃. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

INTERPRETATION OF RESULTS

Positive:
Two red lines are visible in the result window. The intensity of the test line may be
weaker or darker than that of the control line. This still means a positive result.

Negative:
The control line appears in the result window, but the test line is not visible.

Invalid:
If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.




PERFORMANCE CHARACTERS:

Sensitivity and Specificity

The HEV Rapid Test Cassette (Serum/Plasma) was compared with a leading commercial ELISA HEV IgG/IgM test; the results show that the HEV Rapid Test Cassette (Serum/Plasma) has a high sensitivity and specificity.

IgG Result

Relative Sensitivity: 90.0% (95%CI*: 68.3%-98.8%)

Relative Specificity: 98.7% (95%CI*: 95.3%-99.8%)

Accuracy: 97.6% (95%CI*: 94.2%-99.4%) *95% Confidence Intervals


IgM Result

Relative Sensitivity: 93.3% (95%CI*: 77.9%-99.2%)

Relative Specificity: 98.6% (95%CI*: 95.8%-99.7%)

Accuracy: 97.9% (95%CI*: 95.1%-99.3%) *95% Confidence Intervals

Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnostic test and endoscopic medical device respectively. Our products ranged in the following specialties: drug of abuse tests, fertility tests, infectious diseases tests, sexual transmitted diseases tests, tumor markers tests, cardiac markers tests, veterinary tests, and surgical stapler series.

NEW LIFE have 3 wholly-owned and joint stock subsidiary companies, including Orient New Life Medical  Co., Ltd., Orient Gene Biotech Co., Ltd., Qianjing Medical Equipment Co., Ltd.

Company's core technical team with more than 35 employees，3 doctors and 25 masters. They have many years of famous universities in the United States and pharmaceutical companies engaged in the project research and development, production and marketing, business management experience.Company owns hundreds of grade purification workshop and all level of quality checkout room, equipped with various production and testing equipment.