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Sure Care Corporation

Infectious Diease Test, Hbsag Hiv I&Ii Hcv Panel Test, Quick Hbv 3-1 Test manufacturer / supplier in China, offering Infectious Diease Test (HBsAg, HIV I&II, HCV Panel Test) /Quick HBV 3-1 Test, Disposable Pph Stapler for Medical Use (GGW), Digital ECG Machine with Single Three Six Twelve Channel (SC1103) and so on.

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Supplier Homepage Product Diagnostic Products Infectious Diease Test (HBsAg, HIV I&II, HCV Panel Test) /Quick HBV 3-1 Test

Infectious Diease Test (HBsAg, HIV I&II, HCV Panel Test) /Quick HBV 3-1 Test

Purchase Qty.:
(Pieces)
500-99,999 100,000+
FOB Unit Price: US $1 US $0.1
Purchase Qty. (Pieces) FOB Unit Price
500-99,999 US $1
100,000+ US $0.1
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Production Capacity: 50, 000, 000/Year
Transport Package: Single Pack
Payment Terms: L/C, T/T

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Basic Info
  • Model NO.: YX-XMBS-005
  • Application: for Diagnosis
  • 1 Test/Pouch: 25tests/Kit
  • Specification: CE
  • Type: Biological Diagnostic Reagents
  • Form: Strip
  • Trademark: SURECARE
  • Origin: China
Product Description

Specifications
 
 
Detection of HBsAg, HIV I&II, HCV Ab. 
Rapid 
Easy 
Accurateness 


 
                                HBsAg/ HIV I&II /HCV Panel Test Card
FOR THE QUALITATIVE ASSESSMENT OF HBSAG, HIV I&II ANTIBODIES AND HCV ANTIBODY IN HUMAN SERUM, PLASMA OR WHOLE BLOOD
 
 
INTENDED USE
HBsAg/ HIV I&II /HCV Panel Test Card, is an immunochromatography assay for the qualitative detection of Hepatitis B virus surface antigen (HBsAg), antibodies to Human Immunodeficiency Viruses(HIV I&II), antibodies against hepatitis C virus (HCV Ab) in human serum, plasma or whole blood.
 
PERFORMANCE CHARACTERISTICS
HBsAg Test: HBsAg Test showed equivalent detectability to commercially available EIA for HBsAg. A result of 99.17% correlation with EIA was obtained from a clinical study of 1071 specimens.
 
HIV I&II Test: In a clinical evaluation of the performance of HIV I&II Test 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.
In order to check possible interferences with potentially cross-reactive sera, an independent evaluation was performed with one hundred samples. The variety of sera samples containing possibly interfering substances were tested and found no interfering with Rapid HIV I&II Test.
 

Serum Type

Number of samples tested

HIV I&II Test

Negative

Positive

RF Positive

15

15

0

Acute Hepatitis A

10

10

0

Syphilis Positive

5

5

0

Hepatitis A Recovery Phase

10

10

0

Hepatitis C

16

16

0

Infectious disease with non hepatitis B

20

20

0

HBsAg, HBeAg and HBcAb Positive

20

20

0

Fetal Serum

4

4

0

Total

100

100

0

 
HCV Test:
Clinical Specificity: A blood donor population of 2948 individuals was tested negative with 3 different kits from different manufacturers. The specificity of Rapid HCV Ab test was 99.55%.
Clinical Sensitivity: Among 480 clinical hepatitis C patients confirmed positive by RIBA 3.0, 479 were positive when tested with Rapid HCV Ab test. The sensitivity was 99.79%.
No cross reactivity was observed with specimens from patients infected with HAV, HBV, HIV, HTLV, CMV, and TP. 
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