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Hepatitis E Virus Infectious Disease Blood Tests Gold Colloidal Easily Operate

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Good quality Home Testing Kits for sales
Good quality Home Testing Kits for sales
We are satisfied with your quality & services so far. The HIV 1/2 antibody Test performance is perfect.

—— Katrina

I have to say that New Life provides high quality products. The FOB, Troponin I, HIV, HCV, Drug Abuse test all performed very well in our market.

—— Clemen

Your Dengue IgG/IgM and Malaria test perfromed well. Now we want to try your Filariasis test in our market.

—— Primo

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Hepatitis E Virus Infectious Disease Blood Tests Gold Colloidal Easily Operate

China Hepatitis E Virus Infectious Disease Blood Tests Gold Colloidal Easily Operate supplier
Hepatitis E Virus Infectious Disease Blood Tests Gold Colloidal Easily Operate supplier Hepatitis E Virus Infectious Disease Blood Tests Gold Colloidal Easily Operate supplier

Large Image :  Hepatitis E Virus Infectious Disease Blood Tests Gold Colloidal Easily Operate

Product Details:

Place of Origin: China
Brand Name: New Life
Certification: ISO13485,CE
Model Number: Cassette

Payment & Shipping Terms:

Minimum Order Quantity: 5000pcs
Packaging Details: 1pc/pouch, 25pcs/box
Delivery Time: 20-30days
Payment Terms: T/T, Western Union, MoneyGram
Supply Ability: 2000000pcs/month
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Detailed Product Description
Category: Infectious Format: Strip/cassette
Specimen: Whole Blood/Serum/Plasma Testing Time: 5-15 Minutes
Shelf Life: 24 Months Application: Hepatitis E Virus
Accuracy: 97.69%

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.
 
 

ProductCat NoSpecimenSensitivityFormatKit Size
HEV AbYI401S3Serum/PlasmaSee Insert3mm Strip50T
YI401S44mm Strip50T
YI401C33mm Cassette25T
YI401C44mm Cassette25T

 
 
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.
 
Hepatitis E Virus Infectious Disease Blood Tests Gold Colloidal Easily Operate
 
 
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
 

MethodEIATotal Results
HEV Rapid Test Cassette (Serum/Plasma)ResultsPositiveNegative
Positive18220
Negative2150152
Total Results20152172

 
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
 

MethodEIATotal Results
HEV Rapid Test Cassette (Serum/Plasma)ResultsPositiveNegative
Positive28331
Negative2204206
Total Results30207237

 
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
 

 
ORIENT NEW LIFE MEDICAL CO., LTD.
Contact:Jerry Meng
Email:Jerry @ newlifebiotest .com
Tel.+86 18657312116
SKYPEenetjerry

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