In Vitro Diagnostic FDA 100% Specificity 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

Main Features

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"

Intended Use

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.

Assay Procedure

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

Negative:

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.

Positive:

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.

Invalid:

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.

Storage

The kits should be stored at temperature 4-30°C,( the sealed pouch) for the duration of the shelf life (24 months).

In Vitro Diagnostic Hepatitis Test Kit

100% Hepatitis Rapid Test Cassette

FDA Hepatitis Rapid Test kit

In Vitro Diagnostic FDA 100% Specificity Hepatitis Rapid Test Kit Images