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Colloidal GoldInfectious Disease Test KitHIV Rapid Test Kit

SKU: IVD testing kits 1/2,Factory Sale HIV Blood Test/Diagnostic HIV 1/2 Rapid Test Kit.

Product Name: HIV 3line 1+2 Rapid Test Kit, HIV Rapid Test Kit, Accuracy of HIV rapid test, test for HIV, Home HIV test kit, HIV (1+2) Antibody Rapid Test, Home HIV Self Test Kit

Sample type: Serum, Plasma or Whole Blood

Detection type: Qualitative

Method: Colloidal Gold Rapid Test

Usage/Application:  Laboratory / Hospital / Pathology /Home Self Test

Function: Diagnose

Certificate: ISO9001/ ISO13485/ CE by TUV/ MHRA/ WHO

Format: Strip, Cassette, Midstream

Sensitivity: 100%

Specificity: 100%

Total Accuracy: 100%

Reading time: 5-20 minutes

Packaging Details:

Pouch+Box+Carton packaging

(1) With our company’s Logo

(2) With the natural package

(3) With OEM package

(4) ODM

Description

NewScen is a CE, ISO, MHRA,WHO HIV Test Kit manufacturer.

 

1.Product Description:

One Step Anti-HIV1+2 in whole Blood Test is a rapid direct binding screening test for the presence of antibodies to HIV 1 and HIV 2. The test is based on the principle of double antigen sandwich immunoassay for the qualitative detection of Anti-HIV in human whole blood. Purified recombinant antigens are employed to identify Anti-HIV specifically. This one-step test is very sensitive and only takes about 15 minutes. Test results are read visually without any instrumentation.

HIV Rapid Test Kit

2.Intended Use:

Newscen HIV (1+2) Antibody Rapid Test is a single-use, rapid immunoassay for the qualitative detection of antibodies to Human Immunodeficiency Virus type 1 and 2 (HIV-1/ 2) in human serum, plasma or whole blood collected from vein or fingertip. It is intended for use in medical institutions by trained staff.

 

3.Principle:

HIV-1 (gp41 and gp120) and HIV-2 (gp36) specific recombinant antigens are separately precoated onto the membrane in zone 1 and 2 as the capture reagent on the test zone. During the test, the specimen is allowed to react with the colloidal gold particles, which have been conjugated with HIV-1 and HIV-2 specific recombinant antigens. Antibodies to HIV-1 and/ or HIV-2, if present, will specifically bind to the colloidal gold-antigen complex.

When the colloidal gold-antigen-antibody complexes move to the test zone, they will specifically bind to the pre-coated antigens. At the same time, a red-colored line will develop in zone 1 and/ or 2 on the membrane. The absence of these red-colored lines in the test zone (1 and 2) suggests a negative result. To serve as a procedural control, a red-colored line in the control zone will always appear regardless of the presence of antibodies to HIV-1/ HIV-2.

 

4.Procedure of NewScen HIV Test Kit: https://youtu.be/25_iWLp1EcE

1. Place the test cassette on a flat surface. Before unsealing the pouch, allow the test cassette to reach room temperature (4-30°C). Use it immediately once unsealed.

2. Open the pouch and add 1 drop (30-40µL) of the specimen into the sample well (S).

3. When the specimen is completely absorbed, slowly add 1 drop (45-55µL) of diluent buffer vertically into the sample well (S).

4. Avoid dropping specimen or diluent buffer in the observation window. 5. Do not allow the diluent buffer bottle to touch the sample well when dropping the diluent buffer so as to prevent cross-contamination with the specimen.   6. Observe the result between 15-30 minutes after the diluent buffer added.

 

5.Result Interpretation:

hiv test kit price

1. Negative: No red lines appear within 30 minutes in the test zone (1 and 2), only a red line in the control zone (C), which indicates that no antibodies to HIV1+2 have been detected with this test. However, this does not exclude the possibility from infection with HIV.

2. Positive: One red line in the control zone (C) and one or two red visible lines of any intensity in the test zone (1 and 2). indicate the specimen contains HIV-1 and/ or HIV-2 antibodies.

3. Invalid: No red lines appear in the control zone (C), regardless of whether there is a red line in the test zone (1 and 2), indicating that the test is invalid. Discard the test cassette and perform with new cassette.

Built-In Control Newscen HIV (1+2) Antibody Rapid Test has a built-in procedural control that demonstrates assay validity. A red line appeared on the control zone (C) indicates that the test runs correctly.

 

6.MHRA of NewScen HIV Test Kit:

MHRA HIV TEST

 

7.CE Qualified by TUV:

CE tuv newscen

 

8.WHO Certification:

newscen WHO 1 newscen WHO 1