Infectious Disease Test---Rapid Test Kit /Strip/Cassette

• Classification: Physiological Functions of Diagnosis and Monitoring Equipment
• Type: Hbsag Test Kit
• Certification: CE, FDA, ISO13485
• Group: All
• Medical Device Regulatory Type: Type 1
• Transport Package: PP, Carton
• Model NO.: HBsAG-W11/W23
• Specification: Strip/Cassette
• Trademark: OEM
• Origin: China
• HS Code: 3002190090
• Production Capacity: 500000000PCS/Year

Product Description

High Accuracy One Step Rapid Hbsag Test Cassette

One Step Cassette Style HBsAg Test is a rapid direct binding test for HBsAg of hepatitis B,The test is based on the principle of sandwich immunoassay for determination of HBSAg in whole blood.Two Monoclonal antibodies are employed to identify HBSAg specifically. This one step test is very sensitive and only takes about 15-20 minutes. Test results are read visually without any instrument.

 

Directions for Use:

For Whole Blood specimen:

1. Dispense 1 drops of Whole Blood specimen to the "s" well of the test card with the provided plastic dropper according to the figure.
2. Add 1 or 2 drops of Sample Diluent to the sample well, immediately after the specimen is added, from the dropper tip diluent vial (or all contents from the single test ampule).
3. Interpret test results in 20 minutes.

For serum or plasma specimens:

1. Dispense 2 or 3 drops (100 μl) of serum/plasma specimen to the "s" well of the test card with the provided plastic dropper according to the figure
2. start the timer and wait for the colored line(s) to appear.
3. Interpret test results in 20 minute.

Interpretation of Results:

1. Positive: Both purplish red test band and purplish red control band appear on the membrane.The lower the antibody concentration,the weaker the test band.
2. Negative: Only the purplish red control band appears on the membrane.The absence of a test brand indicates a negative result.
3. Invalid: There should always be a purplish red control band in the control region regardless of test result.If control band is not seen, the test is considered invalid. Repeat the test using a new test device.Note: It is normal to have a slightly lightened control band with very strong positive samples as long as it is distinctly visible.