SURE CHECK® HIV Self-Test
MDA Registration number: IVDD2301924-164783
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
A single-use in-vitro diagnostic self-test that detects antibodies to HIV-1 and HIV-2 in fingerstick whole blood. The 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.
| 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
|
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