Description
Benefits
- Innovative: It’s the first rapid point-of-care test that detects both HIV-1/2 antibodies and the HIV-1 p24 antigen, which can appear just 12 to 26 days after infection.1,2
- Empowering: It helps healthcare providers to break the infection cycle by screening for acute HIV infection earlier than traditional 3rd generation HIV antibody tests.4, 5, 6
- Dependable: It provides clear results in just 20 minutes, with built-in quality controls to let you know the test is working.
- Efficient: It requires minimal training and no expensive laboratory equipment.
- Flexible: It’s designed for fingerstick testing of whole blood, as well as serum or plasma samples.
Specifications
Product Information
- Method: Lateral Flow
- Time to Results: 20 minutes
- Storage Conditions: 2 – 30°C
- Shelf Life: 9 months
- Sample Type: Serum/Plasma/Whole Blood
- Kit Contents: 20 or 100 test units
| Product | CE-Marked | Non-CE Marked |
| Alere Determine™ HIV 1/2 Ag/AB Combo (× 20) | 7D2646 | Not Available |
| Alere Determine™ HIV 1/2 Ag/AB Combo (×100) | 7D2647 | 7D2643 |
| Chase Buffer **** | 7D2247 | 7D2243 |
| EDTA Capillaries | 7D2227 | 7D2222 |
| Controls | 7D2626 | 7D2626 |
| Lancets (×100) | 7D22432 | 7D22432 |
| Microsafe Capillary Tubes (×100) | 7D2223 | 7D2223 |
Product Availability Varies By Region
**** For whole blood, order chase buffer
Specificity**
- 99.23 % (Antibody)
- 99.66 % (Antigen)
Sensitivity ***
- 100%
** Seronegative plasma or serum conducted in 9 clinical trial sites: Belgium, Uganda, Senegal, UK, Thailand, France, Ethiopia, South Africa, Colombia. Other viral or bacterial infections (HBV, HCV, HTLV, CMV, Toxo IgG, Syphilis, HSV 1/2, EBV, Flu vaccinated patients and Chlamydia IgG/IgM). Cancer patients. Potentially Interfering Substances include IV drug users, multiparus pregnancy, rheumatoid factor, alcoholic cirrhosis, autoimmune (ANA), high cholesterol, lipemic, high bilirubin, hemolyzed, anti mouse IgG.
*** HIV-1 non B subtypes include A, C, D, F, G, H, J, K, and CRF01_AE, CRF02_AG, CRF06_cpx, CRF09_cpx, CRF11_cpx, CRF35_AD, and BD
Product Information
- Method: Lateral Flow
- Time to Results: 20 minutes
- Storage Conditions: 2 – 30°C
- Shelf Life: 9 months
- Sample Type: Serum/Plasma/Whole Blood
- Kit Contents: 20 or 100 test units
| Product | CE-Marked | Non-CE Marked |
| Alere Determine™ HIV 1/2 Ag/AB Combo (× 20) | 7D2646 | Not Available |
| Alere Determine™ HIV 1/2 Ag/AB Combo (×100) | 7D2647 | 7D2643 |
| Chase Buffer **** | 7D2247 | 7D2243 |
| EDTA Capillaries | 7D2227 | 7D2222 |
| Controls | 7D2626 | 7D2626 |
| Lancets (×100) | 7D22432 | 7D22432 |
| Microsafe Capillary Tubes (×100) | 7D2223 | 7D2223 |
Product Availability Varies By Region
**** For whole blood, order chase buffer
SKU
CE: 7D2646
CE-7D2647
non-CE-7D22643
Chase Buffer-7D2243
CE EDTA Capillaries-7D2227
EDTA Capillaries-7D2222
Controls: 7D2626
Microsafe Capillary Tubes: 7D2223
References
1. Gürtler L, Mühlbacher A, Michl U, et al. Reduction of the diagnostic window with a new combined p24 antigen and human immunodeficiency virus antibody screening assay. J Virol Meth 1998; 75:27–38.
2. Brust S, Duttmann H, Feldner J, Gürtler L, Thorstensson R, Simon F. Shortening of the diagnostic window with a new combined HIV p24 antigen and anti-HIV1/2/O screening test. J Virol Meth 2000; 90:153–65.
4. Hollingsworth TD, Anderson RM, Fraser C. HIV-1 transmission, by stage of infection. J Infect Dis. 2008 Sep 1;198(5):687–93
5. Pilcher CD et al. Amplified transmission of HIV-1: comparison of HIV-1 concentrations in semen and blood during acute and chronic infection. AIDS. 2007 Aug 20;21(13):1723–30
6. Pilcher CD et al Brief but efficient: acute HIV infection and the sexual transmission of HIV. Quest Study; Duke-UNC-Emory Acute HIV Consortium. JID. 2004 May 15;189(10):1785–92.
Note:
Product exclusively available for export to select markets.
