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One Step Infectious Disease Blood Tests , Hepatitis A Test Kit Reliable Result

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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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One Step Infectious Disease Blood Tests , Hepatitis A Test Kit Reliable Result

China One Step Infectious Disease Blood Tests , Hepatitis A Test Kit Reliable Result supplier

Large Image :  One Step Infectious Disease Blood Tests , Hepatitis A Test Kit Reliable Result

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 A
Sensitivity: 99.58%

One Step HAV(hepatitis A virus) IgM Rapid , to detect hepatitis A virus acute break,gold colloidal method

 

Product Name:


One Step HAV(hepatitis A virus) IgM Rapid Diagnostic Test Cassette

 

 

Intended Use:

 

The HAV igM test is a rapid qualitative lateral flow test designed for the qualitative detection of hepatitis A virus infection (HAV) in serum/plasma.

 

Summary:

 

HAV is a positive RNA virus, a unique member of picornavirdae1.Its transmission depends primarily on serial transmission from person to person by the fecal-oral route. Although hepatitis A is not ordinarily a sexually transmitted disease, the infection rate is high among male homosexuals, as result of oral-anal contact2,3. The presence of specific anti-HAV IgM in blood samples suggests acute or recent HAV infection 4-6. The IgM antibody rapidly increases in titer over a period of 4-6 weeks post infection, and then declines to non-detectable levels within 3 to 6 months in most patients 7. The HAV IgM Rapid Test Cassette is to be used to detect anti-HAV IgM in less than 20 minutes by untrained or minimally skilled personnel, without cumbersome laboratory equipment

 

TEST PRINCIPLE

 

The quick one-step test utilizes a sandwich immunochromatographic detection assay,platform If HAV antibody IgM is present in the sample in concentration above the limit, a labeled antigen-dye complex will be formed. This complex is then captured by antibody immobilized in the Test Zone of the membrane, producing a visible pink-rose color band on the membrane. The color intensity will depend on the concentration of HAV antibody IgM present in the sample.

 

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.

 

 

One Step Infectious Disease Blood Tests , Hepatitis A Test Kit Reliable Result

 

One Step Infectious Disease Blood Tests , Hepatitis A Test Kit Reliable Result

 

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

 

 

Method EIA Total Results
HAV Rapid Test Cassette (Serum/Plasma) Results Positive Negative
Positive 50 2 52
Negative 0 416 416
Total Results 50 418 468

 

Relative Sensitivity: 99.9% (95%CI*: 94.2%-100%)

 

Relative Specificity: 99.5% (95%CI*: 98.3%-99.9%)

 

Accuracy: 95.6% (95%CI*: 98.5%-99.9%) *95% Confidence Intervals

 

 

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

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Contact Person: Jerry Meng

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