Newscen Biopharm Co., Limited

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In Vitro Diagnostic FDA 100% Specificity Hepatitis Rapid Test Kit

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Newscen Biopharm Co., Limited
City:tianjin
Province/State:tianjin
Country/Region:china
Contact Person:MrRandy.Zhang
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In Vitro Diagnostic FDA 100% Specificity Hepatitis Rapid Test Kit

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Brand Name :Newscen
Model Number :HBsAg (Hepatitis B Surface Antigen) Test Kit
Certification :ISO9001, CE, TUV, FDA
Place of Origin :China
MOQ :10 Boxes or 400 Kits (40 Kits/Box)
Price :USD0.45/Cassette
Payment Terms :T/T, Western Union, MoneyGram
Supply Ability :100,000 Kits Per Day
Delivery Time :8 days
Packaging Details :40 Kits/Box, 50 Boxes/Carton, 317g/Box, 18kgs/Carton, Box Size: 250x125x65mm, Carton Size: 650x510x330mm
Specimen :Serum, Plasma, Whole Blood
Methodology :Colloidal Gold
Shelf Life :2 Years
Format :Cassette
OEM / ODM :Available
Result Time :Read in 20 Minutes
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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"


In Vitro Diagnostic FDA 100% Specificity Hepatitis Rapid Test Kit


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.

In Vitro Diagnostic FDA 100% Specificity Hepatitis Rapid Test Kit


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

In Vitro Diagnostic FDA 100% Specificity Hepatitis Rapid Test Kit


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 FDA 100% Specificity Hepatitis Rapid Test Kit

In Vitro Diagnostic FDA 100% Specificity Hepatitis Rapid Test Kit

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