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High Accuracy HBsAg Rapid Diagnostic test CassetteWhole Blood/Serum/Plasma Specimen easily and quick operation

Orient New Life Medical Co.,Ltd.
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High Accuracy HBsAg Rapid Diagnostic test CassetteWhole Blood/Serum/Plasma Specimen easily and quick operation

Brand Name : New Life

Certification : ISO13485,

Place of Origin : China

MOQ : 5000pcs

Price : USD0.15-USD1

Payment Terms : T/T, Western Union

Supply Ability : 2000000pcs/month

Delivery Time : 20-30days

Packaging Details : 1pc/pouch, 25pcs/box

Category : Infectious

Format : Strip/cassette

Specimen : Whole Blood/Serum/Plasma

Testing time : 5-15 minutes

Shelf Life : 24 Months

Application : HBsAg

Accuracy : 99.81%

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High Accuracy HBsAg Rapid Diagnostic test CassetteWhole Blood/Serum/Plasma Specimen easily and quick operation

Product Name:


HBsAg Hepatitis B Surface Antigen Test (Cassette)

INTENDED USE

The HBsAg Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of HBsAg in human whole blood, serum, or plasma specimens. This kit is intended to be used as an aid in the diagnosis of HBV infection.

INTRODUCTION

Hepatitis B virus (HBV) is the prototypic member of the hepadnaviruses. In the lipid envelope of this small DNA virus the hepatitis B surface antigen (HBsAg) is located. During the replicative phase of the virus this surface antigen is produced in excess and detectable in the blood of infected person. The antigens HBcAg and HBeAg are parts of the nucleocapsid. The incubation period of HBV is 6 weeks to 6 months.

PRINCIPLE

The HBsAg Rapid Test Device (Whole Blood/Serum/Plasma) has been designed to detect the HBsAg through visual interpretation of color development in the strip. The membrane was immobilized with anti‐HBsAg antibodies on the test region. During the test, the specimen is allowed to react with colored anti‐HBsAg antibodies colloidal gold conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interact with reagents on the membrane. If there were enough HBsAg in specimens, a colored band will from at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the 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. Dispense 2 drops of the specimen or control into the sample well.

4. Hold the buffer bottle vertically and add 1 drop to the sample well. If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops to the sample well.

5. Wait for the colored lines to appear. Interpret results between 15-20 minutes. Do not

interpret results after 20 Minutes.

INTERPRETATION OF RESULTS

Positive:

Two colored lines should be observed in the result window, one in the test region and another one in the control region. The color intensity of the test line may be weaker or stronger than that of the control line.

Negative:

Only the control line appears in the result window.

Invalid:

No line appears in the control region regardless of the presence or absence of the test

line.

PERFORMANCE CHARACTERISTICS

Table: HBsAg Rapid Test vs. EIA

HBsAg Rapid Test
Relative Sensitivity: 99.9% (99.3%‐ + Total
100.0%)*
Relative Specificity: >99.9% (99.7%‐
+ 820 1 821
100.0%)*
EIA
Overall Agreement: 99.9% (99.8%‐99.9%)*
1 2134 2135
*95% Confidence Interval
821 2135 2956

High Accuracy HBsAg Rapid Diagnostic test CassetteWhole Blood/Serum/Plasma Specimen easily and quick operation

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

Product Tags:

bacterial infection blood test

      

home blood test kit

      
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