SURE CHECK® HIV Self-Test
MDA Registration number: IVDD2301924-164783
SURE CHECK® HIV Self-Test is a home-use HIV testing kit that allows you to test yourself for HIV (human immunodeficiency virus) in the privacy of your own home. HIV is a virus that can lead to AIDS (acquired immune deficiency syndrome) if left untreated.
Easy to Use
- Quick blood collection; needs only 2.5 μl of blood
- Patented Barrel Design: Allows direct transfer of blood from finger to test device
Convenient
- Low hands on time, no bottles, no mixing, no pouring
- Innovative test design prevents accidental spilling
Trusted & Proven
- Over 13 million tests used professionally
- Sensitivity: 99.7%; Specificity: 99.9% (trained professional)
- Sensitivity: 97.0%; Specificity: 100% (untrained lay user)*
*Refer to product insert for more details
SPECIFICATION
| Platform | Immunochromatographic Assay |
| Format | Sampler with buffer vial |
| Detection | HIV-1 and HIV-2 antibodies |
| Specimen | Fingerstick whole blood |
| Sensitivity | 97% |
| Specificity | 100% |
| Assay Time | 15 minutes |
| Shelf Life* | 24 months |
*From date of manufacture
HOW TO PURCHASE IN MALAYSIA?
Purchase online and know your status discreetly from the following authorized pharmacies:
|
Performance |
Fingerstick |
|---|---|
|
Trained Professional |
|
|
Sensitivity |
99.7% |
|
Specificity |
99.9% |
|
Untrained Lay User |
|
|
Sensitivity |
97% |
|
Specificity |
100% |
|
Cat. No. |
Product Description |
Test Specimen |
Product Format |
Intended Use |
Intended Use |
Storage Temp. |
Packing Size |
|---|---|---|---|---|---|---|---|
|
60-9508-M |
SURE CHECK® HIV Self-Test |
WB |
Sampler with buffer vial |
Detection of antibodies of HIV Type 1 and 2 |
For Self-Testing |
8-30°C |
1 T/ Kit |
*WB – Whole Blood
INTENDED USE
The SURE CHECK® HIV Self-Test is qualitative, single-use in-vitro diagnostic self-test for detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV 1/2) in fingerstick whole blood. The SURE CHECK® HIV Self-Test is intended for use by untrained lay users in a private setting as a self-test to aid in the diagnosis of HIV infection. The test is intended for people who believe they may have had exposure to the HIV virus or a risk event within the last 3 months period of time, and who are ages 14 and older.
KIT CONTENTS
- Each kit contains components to perform 1 test:
- Instructions for Use (IFU)/Product Insert
- Test Stand
- Alcohol Swab
- Sterile Gauze Pad
- Pouch, containing: SURE CHECK® HIV Self-Test Device, Buffer Cap (attached to the test device), Sterile Safety Lancet, Bandage, Desiccant (discard)
- Disposable Bag
EXAMPLES OF RISK EVENTS
- Individuals who have sex with someone who is HIV positive or whose status you do not know
- Sexually active individuals, regardless of their sexual orientation or gender
- Individuals who use shared needles or syringes
- Individuals who perceive themselves as at risk and have never undergone HIV screening or have never been diagnosed with HIV
HOW DOES THE TEST WORK?
The SURE CHECK® HIV Self-Test has a test strip inside a plastic tube. The test is performed by mixing one drop of blood with a liquid solution contained in the buffer cap. As the test runs you can see the mixture flowing up the strip. When the test is complete, two lines will be visible if antibodies to HIV are detected (CONTROL and TEST lines). Only the CONTROL line appears if there are no antibodies detected.
WHAT YOU NEED TO KNOW BEFORE RUNNING THE TEST
- SURE CHECK HIV Self-Test is a screening test for HIV (the virus responsible for AIDS).
- SURE CHECK HIV Self-Test is intended for use by untrained lay users in a private setting. Please ensure you visit an HIV testing center, health facility or healthcare professional when your result is positive or invalid.
- For single-use only. Do not open foil pouch containing device until ready to test. Please carefully read all of the following instructions prior to using the test.
- You will need a watch, clock, or other timing device.
- Wash hands prior to running test.
- Run test in a well-lit area.
- Use within expiration date