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Alere Determine HIV-1/2 Ag/Ab

Alere Determine™ HIV-1/2 Ag/Ab Combo

Every day counts – now you can help identify HIV just days after infection. The Alere Determine ™ HIV Combo empowers you at the point-of-care, to diagnose HIV earlier than ever before. The Alere Determine™ HIV 1/2 Ag/Ab Combo gives you a new advantage in the fight against AIDS- the ability to identify HIV sooner than conventional rapid tests, which rely solely on the presence of HIV 1/2 antibodies.

The Alere Determine™ HIV 1/2 Ag/Ab Combo is the first rapid point-of-care test that detects both HIV-1/2 antibodies and the HIV-1 antigen, which can appear just 12-26 days after infection¹,² HIV-1/2 antibodies first appear significantly later – 20 – 45 days after infection. By detecting HIV earlier, you are helping to prevent further transmission during this extremely infectious stage.

For more information on this product please visit www.AlereHIV.com, your online resource to discover and explore Alere's transformative approach to HIV Chronic Disease Management.

www.AlereHIV.com

Product exclusively available for export to select markets.

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

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

Product Code

  • 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.

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