HIV home Test

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Min.Order Quantity: 500 Piece/Pieces
Supply Ability: 100000 Piece/Pieces per Month
Payment Terms: T/T
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Quick Details

Type:
Blood Testing Equipments
Brand Name:
BOSON
Place of Origin:
Fujian China (Mainland)
format:
cassette
test specimen:
blood samples

Packaging & Delivery

Packaging Detail: 1 test/pouch,1 set/kit.
Delivery Detail: 10-15 days after receiving the full payment

Specifications

HIV home test card:
can be performed at home by your self
safety and accurate
sensitivity: 99.6%
specificity: 99.7%

 HIV HOME TEST CARD

 

INTENDED USE

Rapid HIV I&II Test Card is a single use device,for qualitative detection of antibodies to Human Immunodeficiency Viruses I&II (HIV I&II) in human serum, plasma or whole blood. The Rapid HIV I&II Test Kit provides private at-home HIV testing with fast and reliable result, and at a time when you needed to know the most!

 

 

TEST PROCEDURE

1. Tear open the alcohol prep ped.

2. Using the alcohol prep ped to clean your finger (usually the midius or the ring finger) from pulp to the surrounding.

3. Remove the cover as the arrow marks.

4. Twist and pull out the protection knob of the lancet.

5. Place the lancet at the finger pulp and press the trigger to sting the finger.

 6. Using the transfer pipet to collect about 1 to 2 dropps of blood sample.

7. Place 1 drop of blood sample into the sample well marked as “S”.

 8. Uncap the sample buffer bottle.

9. Add 1 drop of sample buffer into the sample well marked as “S”. 

10. Read the result at 20 minutes. Reactive samples can be read as soon as distinct colored bands appear on both test zone and control zone. To confirm a negative result, please read the result at 20 minute after adding sample.

 

INTERPRETATION OF RESULTS 

Reactive: Positive

If two colored bands are visible within 20 minutes, the test result is reactive or positive and valid. The test result can be read as soon as a distinct colored band appears in the test area.

Non-reactive: Negative

If test area has no color band and the control area displays a colored band, the result is non-reactive or negative and valid.

Invalid result:

The test result is invalid if a colored band does not form in the control region. The sample must be re-tested, using a new test device.

 

PERFORMANCE CHARACTERISTICS

In a clinical evaluation of the performance of HIV I&II Test Card using 2567 confirmed negative and 510 positive samples, sensitivity was 99.6% (508/510) and specificity was 99.7% (2560/2567). The overall agreement with the reference ELISA tests is 99.7%.

 

Sites

HIV positive sera

HIV negative sera

 

 

Total

Positive

Total

Negative

 

 

One

101

99

149

142

 

Two

7

7

1784

1784

 

Three

300

300

436

436

 

Four

102

102

198

198

 

Total

510

508

2567

2560

 

Agreement

99.6%

99.7%

           

 

The precision of three lots tested with Chinese FDA QC panel showed 100% agreement.

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Boson Biotech Co., Ltd. is a professional manufacturer of in vitro diagnostic kits. We develop and manufacture high-quality products and other immunoassay kits for worldwide markets.

Our 5,000-square-meter facilities are operated strictly under ISO13485:2003 and GMP guidelines. We combine the technological, material and labor resources of China and USA to develop, manufacture and supply high quality in vitro diagnostic products efficiently and cost effectively. Currently, we are offering ... View detail

Basic Information

Product/Service (We Sell): rapid test,DOA Test,HIV Test,HBV Test,HBsAg Test  
Number of Employees: 101 - 200 People  

Trade & Market

Main Markets: Oceania
Eastern Europe
Southern Europe
South Asia
Northern Europe
Western Europe
Eastern Asia
Africa
North America
South America
Southeast Asia
Domestic Market
Total Annual Sales Volume: US$5 Million - US$10 Million  
Export Percentage: 51% - 60%  

Factory Information

Factory Size (Sq.meters): 10,000-30,000 square meters  
Factory Location: Xiamen, Fujian  
Number of Production Lines: 3  
Number of R&D Staff: 31 - 40 People  
Number of QC Staff: 5 - 10 People  
Management Certification: ISO13485   GMP  
Contract Manufacturing: OEM Service Offered   Design Service Offered   Buyer Label Offered  

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China (Mainland) | Manufacturer | Contact Details
Experience: Established 2001

Communicate with Supplier:

Mr. Liangzhen Jiang
Mr. Liangzhen Jiang:
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