MediLytic Biomedicals HIV-1 & 2 Test Kit

MediLytic Biomedicals HIV-1 & 2 Test Kit – Pack of 5

The MediLytic Biomedicals HIV-1 & 2 Test Kit is a rapid in-vitro diagnostic device for the qualitative detection of antibodies to HIV-1 and HIV-2 in human serum or plasma. Manufactured by Koshbio Private Limited, Faridabad under Manufacturing Licences MFG/IVD/2022/000044 (Class B) and MFG/IVD/2021/000117 (Class C&D), and marketed by MediLytic Biomedicals Pvt. Ltd., Lucknow, this lightweight test card is designed to be specific, sensitive and simple to read. Supplied as a pack of 5 test devices, it suits repeat screening or small clinic use.

Key Features

• Detects antibodies to both HIV-1 and HIV-2 on one device
• Rapid qualitative result read visually – no analyser required
• Works with human serum or plasma samples
• Wide storage range of 2–40°C, convenient for Indian conditions
• Licensed IVD device from a CDSCO-licensed manufacturing facility

What’s in the Pack

• 5 HIV-1 & 2 test devices – each individually sealed with desiccant
• Sample dropper – for transferring serum or plasma
• Assay buffer – to develop the sample
• Instruction leaflet – full procedure and result interpretation

Kit contents are as supplied by the manufacturer; please refer to the pack insert for the definitive list.

Uses & Benefits

• Rapid screening for HIV-1 and HIV-2 antibodies
• Results within minutes, supporting quicker clinical decisions
• Pack of 5 gives better value than single-test packs
• Supports early detection, which allows earlier medical care
• Clear control and test line indicators reduce reading errors
• Compact card format is easy to store and transport

Directions for Use

• Allow the sealed device and sample to reach room temperature before testing
• Open the pouch and use the device immediately; label it with the sample identity
• Add the specified volume of serum or plasma to the sample well, followed by the assay buffer
• Read the result within the time window given in the pack insert – do not interpret it later
• Use only as instructed on the manual/label or by a healthcare professional

Precautions

• For in-vitro diagnostic use only. Each device is single use – never reuse
• This is a screening test, not a diagnosis. Any reactive result must be confirmed by a laboratory test and reviewed by a doctor
• A negative result does not rule out infection during the window period
• Do not use if the pouch is damaged or opened, or after the printed expiry date
• Treat all specimens as potentially infectious and dispose of them as biomedical waste
• Read the instruction leaflet in full before use; keep away from children

Storage

• Store between 2°C and 40°C; do not freeze
• Keep sealed in the original pouch, away from direct sunlight and humidity
• Stable until the expiry date printed on the pack

Disclaimer

This product is an in-vitro diagnostic screening device and is not a substitute for professional medical testing, diagnosis or advice. If your result is reactive, or if you have any concern about HIV exposure, consult a qualified doctor or an approved testing centre for confirmatory testing and counselling.