Neo Hi-V Self Test Kit (Serum / Plasma / Whole Blood) for home use

Neo Nostics®
HI-V 4th Gen Test Kit (Serum / Plasma / Whole Blood)

INTENDED USE

The HI-V 4th gen test kit is a lateral flow immunoassay for the simultaneous detection and differentiation of anti-HI-V-1/anti-HI-V-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 HI-V. Any reactive specimen with the HI-V 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 (HI-V-1 and HI-V-2) are enveloped single strain RNA positive viruses. The causative relationship between HI-V-1 and HI-V-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.
HI-V-1 has been isolated from patients with AIDS and AIDS-related complex, and from healthy individuals with a high risk for developing AIDS.
HI-V-2 has been isolated from West African AIDS patients and from sero-positive asymptomatic individuals.

The two types of HI-V have significant variation in sequences.
HI-V-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 HI-V-2 has been classified into at least five subtypes (A through E).

Some HI-V-1 variants share up to 50% homology in their envelope genes with the sequences of more common prototype strains.
Both HI-V-1 and HI-V-2 viruses can elicit strong immune responses, including the production of anti-virus antibodies.

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

PRINCIPLE

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

A burgundy colored pad containing recombinant HI-V-1+2 antigen with colloid gold (HI-V-1+2 conjugates)

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

Rabbit IgG-gold 

A nitrocellulose membrane strip containing:

Two test bands (HI-V antibody T and antigen T bands)

One control band (C band)

Coatings:

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

Antigen T band → pre-coated with anti-P24 antibody (detects P24 antigen to HI-V-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 HI-V P24 antigen is present, it binds to anti-P24 antibody conjugate → captured → burgundy band on Ag T region.

If HI-V-1+2 antibodies are present, they bind to HI-V-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.

Storage:

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

(Illustrated by image: 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 may appear as early as 1 minute.

Discard test device after reading to avoid confusion.