Professional Manufacturer of Rapid Test Devices

About Us
Factory Tour
Quality Control
Contact Us
Home ProductsHIV Rapid Test Kit

Qualitative Screening 99% Specificity CIA HIV Rapid Test Kit

Qualitative Screening 99% Specificity CIA HIV Rapid Test Kit

  • Qualitative Screening 99% Specificity CIA HIV Rapid Test Kit
  • Qualitative Screening 99% Specificity CIA HIV Rapid Test Kit
  • Qualitative Screening 99% Specificity CIA HIV Rapid Test Kit
  • Qualitative Screening 99% Specificity CIA HIV Rapid Test Kit
Qualitative Screening 99% Specificity CIA HIV Rapid Test Kit
Product Details:
Place of Origin: China
Brand Name: Newscen
Certification: ISO9001, CE, TUV, SFDA
Payment & Shipping Terms:
Minimum Order Quantity: 10 Boxes or 400 Kits (40 Kits/Box)
Price: Negotiable as per Order Quantity
Packaging Details: 40 Kits/Box, 50 Boxes/Carton, 317g/Box, 18kgs/Carton, Box Size: 250x125x65mm, Carton Size: 650x510x330mm
Delivery Time: 8 days
Payment Terms: T/T, Western Union, MoneyGram
Supply Ability: 100,000 Kits Per Day
Contact Now
Detailed Product Description
Specimen: Serum, Plasma, Whole Blood Methodology: Colloidal Gold
Shelf Life: 2 Years Format: Cassette
OEM / ODM: Available Result Time: Read In 20 Minutes
High Light:

99% HIV Rapid Test Kit

,

Qualitative Screening HIV Test Kit

,

CIA HIV Rapid Test Kit

HIV(1+2) Antibody Rapid Test Kit


For qualitative detection of HIV(1+2) Antibodies in serum/plasma and whole Blood
 
Main Features


☀ Sensitivity: 100%
Specificity: Higher than 99%
Simple: No Instrument Required

☀ High accurate, early detection of the presence of HIV

☀ Unique 3-line Patented Design
☀ Convenient: Room Temperature Storage, Built-In Control line
☀ Able to differentiate HIV Type I and Type II
Certified by Authoritative Certification
Winner of "the 2008 National HIV Antigen Diagnostic Kit for Clinical Performance Assessment"
 
Intended Use


The HIV-1/2 Rapid Diagnostic Test (RDT) is a qualitative test for the detection of antibodies to Human Immunodeficiency Virus type 1 and 2 (HIV-1/2) in human serum/plasma.

 

It is considered as an initial screening test for HIV-1/2 antibodies. All positive specimens must be confirmed with Western Blot or other qualified EIA.
 
Qualitative Screening 99% Specificity CIA HIV Rapid Test Kit 0


Principle


HIV-1/2 RDT is a chromatographic immunoassay (CIA) for the detection of antibodies to HIV-1/2 in human serum/plasma. HIV-1/2 specific antigens are precoated onto membrane as a capture reagent on the test region.
 
During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with HIV-1/2 specific antigens. Antibodies to HIV-1/2, if present, a red colored band will develop on the membrane in proportion to the amount of HIV-1/2 antibodies present in the specimen.
 
Absence of this red colored band in the test region suggests a negative result. To serve as a procedural control, red colored band in the control region will always appear regardless the presence of antibodies to HIV-1/2.

 

Materials Required But Not Provided


☀ Timer or stopwatch
☀ Biohazard disposal container
☀ Blood collection devices, for the testing of venous whole blood, serum or plasma
☀ Disposable gloves

For finger stick samples, the following materials are required:
Alcohol pad
Sterile lancet
Sterile gauze or cotton

 

Reagents and Materials Provided


Each kit contains:
☀ 40 test cassettes(individually pouched)
☀ One bottle of diluent buffer(5ml)
☀ 40 disposable plastic droppers
☀ Each pouch contains one cassette with one desiccant bag
☀ Instruction for use

 

Qualitative Screening 99% Specificity CIA HIV Rapid Test Kit 1


Assay Procedure


☀ Place the test cassette on flat surface. Before unseal the pouch, allow the test cassette to reach room temperature(4-30°C) .Use it immediately once unsealed.
☀ Open the pouch and add1drop(30-40uL) of specimen into the sample well(S) .
☀ When the specimen is completely absorbed, slowly add1drop(45-55pL) of diluent buffer vertically into the sample well(s) .
☀ Avoid dropping specimen or diluent buffer in the observation window.
☀ Do not allow the diluent buffer bottle touch the sample well when dropping the diluent buffer so as to prevent the cross contamination with the specimen.
☀ Observe the result between 15-30 minutes after the diluent buffer added.

 

Qualitative Screening 99% Specificity CIA HIV Rapid Test Kit 2

 


Interpretation of Results


Qualitative Screening 99% Specificity CIA HIV Rapid Test Kit 3


 Negative: No apparent band in the test region (1 and 2), only one red band appears in the control region (C). This indicates that no HIV1/2 antibodies have been detected.


 Positive: In addition to the band in the control region (C), other one or two red bands will appear in the test region (1 and 2). This indicates that the specimen contains HIV1/2 antibodies.


 Invalid: If no band appears in the control region(C), regardless of the presence or absence of line in the test region (1 and 2). It indicates a possible error in performing the test. The test should be repeated using a new device.

 

Qualitative Screening 99% Specificity CIA HIV Rapid Test Kit 4


Storage


Newscen HIV(1+2) Antibody Rapid Test can be stored at room temperature(4-30℃, do not freeze) for 24 months from the date of manufacture.
Keep the test cassette in sealed pouch until use.

 

Once you have taken the test cassette out of the pouch, perform the test as early as possible(within 1hour) to avoid test cassette from becoming moist. Do not use the test beyond the indicated expiration date.
The diluent buffer should be stored at room temperature(4-30℃, do not freeze) .

 

Warning


For Invitro Diagnostic Use ONLY


Read the package insert completely before use. It is very important that the correct procedure is followed. Fail to add the patient sample may lead to a false negative result (i.e.a missed positive) .
 
Qualitative Screening 99% Specificity CIA HIV Rapid Test Kit 5

 

Qualitative Screening 99% Specificity CIA HIV Rapid Test Kit 6

Contact Details
Newscen Biopharm Co., Limited

Contact Person: Mr. Randy.Zhang

Tel: 008618611273771

Send your inquiry directly to us (0 / 3000)