Gold Member Since 2016
Shanghai Iven Medical Technology Co., Ltd.

HIV, HIV Test, Diagnostic Kit manufacturer / supplier in China, offering Aids HIV One Step Rapid Test Kit, Rotator 1, Automatic De-Capping Refrigerated Centrifuge and so on.

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Aids HIV One Step Rapid Test Kit

FOB Price: US $0.41 / Piece
Min. Order: 1,000 Pieces
Min. Order FOB Price
1,000 Pieces US $0.41/ Piece
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Payment Terms: L/C, T/T, Western Union

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Basic Info
  • Model NO.: HIV16-01
  • Material: Plastic
  • Ethylene Oxide Sterilization: Without Ethylene Oxide Sterilization
  • Group: Adult
  • Trademark: Labtub
  • Type: Test Strips & Test Tube
  • Certification: CE, ISO13485
  • Quality Guarantee Period: 18 Months
  • Logo Printing: With Logo Printing
  • Origin: China
Product Description
Specification
Cassette (30 Tests/Kits)

Intended usage
Diagnostic Kit for Antibody to Human Immunodeficiency Virus (Colloidal Gold) is mainly used for in vitro qualitative detection of antibodies to HIV-1, HIV-2 in human whole blood, serum or plasma, is to aid in clinical diagnosis of HIV infection.

 
Characteristics
  1. Used for in vitro qualitative detection of antibodies to HIV-1,HIV-2,(P24 and HIV-O also be available) in human whole blood, serum or plasma.
  2. Can be used to the whole blood specimens anti-coagulated by sodium citrate, heparin, EDTA, or separate plasma, separate serum.
  3. Sensitivity: In the internal laboratory study, 100 tests of whole blood (including 30 tests of fingertip blood), 100 tests of serum, 100 tests of plasma were detected by ELA and Western Blot for positive, those samples' detection rate is 100% by the kit.
  4. Specificity: The kit does not cross react with specimen with HAV, HCA, HBV, Treponema Pallibum and RF. Common interfering substances such as bilirubin (30mg/dL), triglycerides(12000mg/L), rheumatoid factor (RF)(4000IU/mL) had no effect on detection results.
  5. The results should be judge within 15 minutes.
 

Detection illustration

Aids HIV One Step Rapid Test Kit
 
Results judgement

Aids HIV One Step Rapid Test Kit

Product performance indicators

1.    Sensitivity

In the internal laboratory study, 100 tests of whole blood (including 30 tests of fingertip blood), 100 tests of serum, 100 tests of plasma were detected by ELA and Western Blot for positive, those samples' detection rate is 100% by the kit.
 
 ELAWestern Blot
70 tests of whole blood
(Exclusive fingertip blood)
100% positive100% positive
30 tests of fingertip blood100% positive100% positive
100 tests of serum100% positive100% positive
100 tests of plasma100% positive100% positive

Laboratory clinical comparison of reference kits

1.    Laboratory clinical comparison with Alere kit
 

 

 
Reference Kit (Alere)Total
PositiveNegative
Assessment Kit (Labtub)Positive3000300
Negative0800800
Total Amount3008001100
 
(PPA) =100% (95%CI, 98.74%~100%)
(NPA) =100% (95%CI, 99.52%~100%)
(OPA) =100% (95%CI, 99.65%~100%)
 
Kappa=1 >0.75; P=0<0.05, it can be considered that there is a high consistency between detection results of the two kinds of kit.
 
2.    Laboratory clinical comparison with Abbott kit
 
  Reference Kit (Abbott)Total
PositiveNegative
Assessment Kit (Labtub)Positive3000300
Negative0800800
Total Amount3008001100
 
(PPA) =100% (95%CI, 98.74%~100%)
(NPA) =100% (95%CI, 99.52%~100%)
(OPA) =100% (95%CI, 99.65%~100%)
 
Kappa=1 >0.75; P=0<0.05, it can be considered that there is a high consistency between detection results of the two kinds of kit.

Aids HIV One Step Rapid Test Kit
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