Professional Manufacturer of Rapid Test Devices
|Place of Origin:||China|
|Certification:||ISO9001, CE, TUV, FDA|
|Model Number:||HBsAg (Hepatitis B Surface Antigen) Test Kit|
|Minimum Order Quantity:||10 Boxes or 400 Kits (40 Kits/Box)|
|Price:||Negotiable as per Order Quantity|
|Packaging Details:||40 Kits/Box, 50 Boxes/Carton, 317g/Box, 18kgs/Carton, Box Size: 250x125x65mm, Carton Size: 650x510x330mm|
|Delivery Time:||8 days|
|Payment Terms:||T/T, Western Union, MoneyGram|
|Supply Ability:||100,000 Kits Per Day|
|Specimen:||Serum, Plasma, Whole Blood||Methodology:||Colloidal Gold|
|Shelf Life:||2 Years||Format:||Cassette|
|OEM / ODM:||Available||Result Time:||Read In 20 Minutes|
In Vitro Diagnostic Hepatitis Test Kit,
100% Hepatitis Rapid Test Cassette,
FDA Hepatitis Rapid Test kit
HBsAg (Hepatitis B Surface Antigen) Diagnostic Kit (Colloidal Gold)
For The Qualitative Detection of Hepatitis B Surface Antigen In Serum/Plasma and Whole Blood
1. High Sensitivity: > 96%
2. Specificity: 100%
3. Reliable: Accuracy higher than 98%, early detection of the presence of HBsAg Antigen.
4. Simple: No Instrument Required
5. Convenient: Room Temperature Storage Built-In Control
6. Fast: Results in 5-30 minutes, strong positive results may be observed promptly within 3 minutes
7. Certified by Authoritative Certification System and Standards
8. Winner of "the National Rapid Diagnostic Kit for Clinical Performance Assessment"
The HBsAg Rapid Test is a Chromatographic immunoassay (CIA) for direct qualitative detection of Hepatitis B type virus surface antigen (HBsAg) in human serum /plasma and whole blood.
Reagents and Materials Provided
1. One sealed pouched cassette with desiccant and a disposable pipette..
2. Blood diluent in a dropper bottle. Store at 2-8℃
3. One piece of operating instruction with 40 test pouches.
Sample Collection and Preparation
Whole Blood ( Fingerstick Specimens)
Clean the area to be lanced with an alcohol swab.
Squeeze the end of the fingertip and pierce it with a sterile lancet ; Wipe away the first drop of blood with sterile gauze or cotton; Use micropipette to obtain about 100ul fresh blood.
Serum/Plasma: Add 70-100ul or 2-3 drops of serum or plasma into sample well. Observe the result in 5-20 minutes.
Whole Blood: Add 1 drop of whole blood into sample well, after all blood is completely absorbed. Add 1 drop of whole blood diluent. Observe the result in 5-20 minutes.
Interpretation of Results
No apparent band in the test region (T), a pink-colored band appears in the control region (C). This indicates that no HBsAg antibody has been detected.
In addition to a pink-colored band in the control region (C), a pink-colored band will appear in the test region (T). This indicates that the specimen contains HBsAg.
If no band appears in the control region (C), regardless of the presence or absence of line in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.
Warning and Precautions
FOR IN VITRO DIAGNOSTIC USES ONLY; All patient samples should be treated as if capable of transmitting diseases; Do not interchange reagents from different lots or use test kit beyond expiration date; Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.
The kits should be stored at temperature 4-30°C,( the sealed pouch) for the duration of the shelf life (24 months).
Contact Person: Mr. Randy.Zhang