Neo HIV Self Test Kit (Serum / Plasma / Whole Blood)

Neo Nostics®

HIV 4th Gen Test Kit (Serum / Plasma/ Whole Blood)

INTENDED USE

The HIV 4th gen test kit is a lateral flow immunoassay for the simultaneous detection and differentiation of anti-HIV-1/anti-HIV-2 antibodies (IgG, IgM, IgA) and P24 antigen in human serum, plasma, or whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of infection with HIV. Any reactive specimen with the HIV 4th gen test kit must be confirmed with alternative testing method(s) such as ELISA or PCR.
For in vitro diagnostic use only. For professional use.

SUMMARY

Human immunodeficiency virus type I and type II (HIV-1 and HIV-2) are enveloped single strain RNA positive viruses. The causative relationship between HIV-1 and HIV-2 viruses and acquired immunodeficiency syndrome (AIDS) has been established over decades.
P24 antigen has been isolated from early patients with AIDS and AIDS-related complex.
HIV-1 has been isolated from patients with AIDS and AIDS-related complex, and from healthy individuals with a high risk for developing AIDS.

HIV-2 has been isolated from West African AIDS patients and from sero-positive asymptomatic individuals.

The two types of HIV have significant variation in sequences.

HIV-1 has been divided into three groups: group M (for major), including at least ten subtypes (A through J); group O (for outlier); and group N (for non-M, non-O).

Similarly, the HIV-2 has been classified into at least five subtypes (A through E).

Some HIV-1 variants share up to 50% homology in their envelope genes with the sequences of more common prototype strains.

Both HIV-1 and HIV-2 viruses can elicit strong immune responses, including the production of anti-virus antibodies.

Once infected with HIV virus, the P24 antigen will be appeared in bodies. Presence of specific anti HIV-1 and/or HIV-2 virus antibody in blood, serum and plasma indicates the exposure of an individual to the HIV-1 and/or HIV-2 virus, being of great value.

PRINCIPLE

The HIV 4th gen test kit is a lateral flow chromatographic immunoassay.
The test cassette consists of:

A burgundy colored conjugate pad containing recombinant HIV-1+2 antigen conjugated with colloid gold (HIV-1+2 conjugates),

Anti-P24 antibody conjugated with colloid gold (anti-P24 antibody conjugates),

Rabbit IgG-gold conjugates,

A nitrocellulose membrane strip containing:

Two test bands (HIV antibody T and antigen T bands)

Two control bands (C band).

Coatings:

Antibody T band → pre-coated with HIV-1+2 antigen (detects antibodies to HIV-1+2)

Antigen T band → pre-coated with anti-P24 antibody (detects P24 antigen to HIV-1+2)

C band → pre-coated with goat anti-rabbit IgG antibody

How it works:
When an adequate volume of test specimen is dispensed into the sample well of the cassette, it migrates via capillary action:

If HIV P24 antigen is present, it binds to anti-P24 antibody conjugate → captured → burgundy band on Ag T region.

If HIV-1+2 antibodies are present, they bind to HIV-1+2 conjugates → captured → burgundy band on Ab T region.

A C band must appear for the test to be valid. If absent, the test is invalid and should be repeated.

STORAGE AND SHELF LIFE

Store test device at 2-30°C. Effective until expiry date on package.

Do not store in direct sunlight.

Keep in a cool, dry place; do not freeze.

Valid for 24 months.

Discard expired products.

Maintain 15-30°C during testing.

Test patient samples immediately if possible.

Humidity-sensitive product – use immediately after opening.

Discard any improperly sealed products.

MATERIAL

Material provided:

Individual sealed pouches, each containing:

Test device

Desiccant pouch

Extraction tubes

Extraction buffer in dropper bottle (6mL): 0.01M phosphate buffer saline (PBS)

SPECIMEN COLLECTION AND PREPARATION

Handle all human-origin materials as infectious using standard biosafety procedures.

Plasma

Collect blood by venipuncture.

Centrifuge to separate plasma.

Withdraw plasma into pre-labeled tube.

Serum

Collect blood by venipuncture.

Allow to clot.

Centrifuge to separate serum.

Withdraw serum into pre-labeled tube.

Store specimens at 2–8°C up to 5 days.

For long storage: freeze at -20°C.

Avoid multiple freeze-thaw cycles.

Bring to room temperature slowly before testing.

Centrifuge if particulate matter is visible.

Whole Blood

Collect in container with anticoagulant via finger prick or venipuncture.

Do not use hemolyzed blood.

Store at 2–8°C, test within 24 hours.

TEST PROCEDURE

(The image includes: 1 drop of serum/plasma/whole blood → 2 drops buffer → 15 minutes)

Bring specimen and test components to room temperature. Mix if thawed.

Open pouch, remove device, and place on flat surface.

Label device with specimen ID.

Add 1 drop of sample (~30 µL) to each of the two sample wells. Then add 2 drops of buffer (~80 µL) to each.

Start timer.

Read results at 15 minutes.

Do not read after 15 minutes.

Positive results can be visible in as short as 1 minute.

Discard test device after interpretation to avoid confusion.