Hi-V Aids test kit for home use (Serum / Blood / Plasma) H-iv

Product Description

This Antibody Rapid Test Kit is a qualitative, immunochromatographic diagnostic device designed for the in vitro detection of specific antibodies in human serum, plasma, or whole blood. It is intended for professional use only and delivers fast, reliable preliminary screening results. The kit is ideal for clinical environments, outreach initiatives, and emergency screening situations requiring quick and dependable diagnostic performance.

Test Type: Immunochromatographic rapid assay

Sample Types: Serum, plasma, or whole blood

Result Time: Results available in 15 minutes

Storage Conditions: Store between 2°C and 30°C, away from direct sunlight and moisture

Shelf Life: Indicated on packaging (typically up to 24 months)

Kit Components

Each kit includes:

Rapid Test Device

Alcohol Pad

Disposable Lancet

Sample Dropper (Plastic Pipette)

Buffer Solution Vial

Desiccant Packet (moisture control)

Instructions for Use (IFU)

How to Use the Antibody Rapid Test Kit

Step-by-Step Instructions

Preparation

Wash and dry hands thoroughly.

Open the sealed pouch only when ready to use.

Lay all components on a clean, flat surface.

Clean the fingertip with the alcohol pad and allow it to air dry.

Blood Collection

Use the disposable lancet to prick the cleaned fingertip.

Gently squeeze the fingertip to produce a drop of blood.

Sample Application

Use the dropper to collect 1 drop of blood.

Dispense the blood into the sample well marked “S” on the test cassette.

Buffer Addition

Add 2 drops of the buffer solution into the same well (S).

Result Waiting Time

Wait 15 minutes before reading the result.

Do not interpret the result after 20 minutes.

Interpreting the Results

Negative Result:

One colored line appears in the Control Line (C) region.

No line appears in the Test Line (T) region.

Positive Result:

Two colored lines appear—one in the Control Line (C) region and one in the Test Line (T) region.

Even a faint line at the T line should be considered positive.

Invalid Result:

No line appears in the Control Line (C) region, regardless of the presence of a line at T.

The test is invalid and should be repeated using a new device.

Precautions & Warnings

For in vitro diagnostic use only.

Do not reuse any test components.

Use only within the expiration date indicated.

Do not use if the pouch is damaged or previously opened.

Dispose of used components properly according to local regulations.

Performance and Accuracy

Based on clinical evaluation:

Relative Sensitivity: 99.75%

Relative Specificity: 99.87%

Total Accuracy: 99.85%

This rapid test has been validated against standard laboratory methods and demonstrates high sensitivity and specificity, making it a reliable tool for antibody screening.