Alere Determine™ HIV-1/2 Ag/Ab Combo

Features

  • Detect both HIV-1/2 antibodies and the HIV-1 p24 antigen, which can appear just 12-26 days after infection.1,2

    Point of care lateral flow strip test with results provided in just 20 minutes.

     

    Offers an earlier window of detection than third generation antibody only rapid point-of-care tests.

  • Detect HIV Sooner

    The Alere Determine™ HIV-1/2 Ag/Ab Combo gives you a new advantage in the fight against AIDS – the ability to detect 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 test detects both HIV-1/2 antibodies and the HIV-1 p24 antigen, which can appear just 12-26 days after infection.1,2  HIV-1/2 antibodies first appear significantly later – 20 to 45 days after infection.

    Alere Determine™ HIV-1/2 Ag/Ab Combo
    Kinetic of HIV Markers During Infection
    4th Generation HIV Detection

  • Any photos displayed are for illustrative purposes only.

  • Point-of-care
    4th generation HIV testing

    The Alere Determine™ HIV-1/2 Ag/Ab Combo is the first rapid point-of-care 4th generation test.

    The combination of p24 antigen and IgM/IgG antibody detection offers an earlier window of detection than third generation antibody only rapid point-of-care tests.

    In a study by Pilcher et al 3 the Alere Determine™ Combo test increased detection of HIV infection compared to all existing antibody-only rapid tests, demonstrating 96% sensitivity and 98.9% specificity.

    “The Alere Determine™ HIV-1/2 Ag/Ab Combo..increased detection of HIV infection compared to all existing antibody-only rapid tests.” Dr C. Pilcher.3

  • Break the Infection Cycle

    Break the infection cycle

    The Alere Determine™ HIV-1/2 Ag/Ab Combo helps to break the infection cycle by screening for HIV infection earlier than traditional third generation HIV antibody tests.4,5,6

    Studies have demonstrated that persons with early HIV infection are more likely to transmit HIV than persons with established infection1, contributing significantly to overall HIV transmission.2

    By detecting HIV earlier, you are helping to prevent further transmission during this extremely infectious early stage.

    This is vitally important considering that individuals who are unaware of their infection are 3.5 times more likely to transmit the virus to someone else.7

    Break the Infection Cycle

    Screening, made easy

    Alere Determine™ HIV-1/2 Ag/Ab Combo is easy to perform, requires minimal training and no expensive lab equipment.

    Test results are provided in just 20 minutes. Quality controls are built-in and let you know the test is working properly. It’s designed for testing fingerstick and venous whole blood, serum and plasma samples.

  • Testing high risk populations

    Identifying HIV infection early, during the most infectious stage offers significant benefits, particularly in high risk populations such as men who have sex with men and injecting drug users.

    Patients who are aware of their status are less likely to transmit the virus to others 8 and are better informed for their own health decisions.

    Fourth generation rapid tests, such as the Alere Determine™ HIV-1/2 Ag/Ab Combo, that can be provided at the point of care, are ideally suited for this purpose. These tests are versatile enough for use in a variety of settings, requiring minimal equipment and training.

    A US study 3, targeting patients with high risk exposure demonstrated that the Alere Determine™ HIV-1/2 Ag/Ab Combo was able to detect the majority of HIV RNA positive patients. In contrast, the majority of these patients were not detectable by the third generation tests also evaluated.

    The powerful next generation for point-of-care

    The enhanced detection capability of 4th generation rapid tests was demonstrated in an evaluation by Fox et al.11 

    In this evaluation the Alere Determine™ HIV-1/2 Ag/Ab Combo test detected 50% of the laboratory confirmed p24 Ag positive/HIV-1/2 antibody negative samples, samples that would not have been detected by third generation antibody-only rapid tests. This enhancement was also demonstrated by Smit et al 10, who saw a 64% improvement over third generation rapid tests, detecting infections that would otherwise have been missed. 

    Closing the diagnostic window period through the use of fourth generation rapid point of care testing will empower these services to detect more infections and detect infections earlier.

    Globally, the number of facilities offering rapid point-of-care HIV testing continues to grow.9 The second and third generation antibody-only tests that are widely used in testing services detection HIV infection after seroconversion, typically 20-45 days after infection, missing early infection. 

  • Improve case finding

    Case finding can be substantially improved by detecting HIV infection sooner.12

    The Alere Determine™ HIV-1/2 Ag/Ab Combo has demonstrated an ability to detect some of the earliest infections in a recent study conducted in Malawi, Africa.13 Of the eight acute infections identified by high sensitivity p24 ELISA and RNA testing, the Alere Determine™ HIV-1/2 Ag/Ab Combo test was able to detect two of these infections, an achievement not possible in other rapid antibody tests.

    “Combo may miss acute infections during the 10-day interval when only RNA can be detected but identify those during the subsequent period (also ~10 days) when results of other rapid antibody tests are still negative.” Dr B. Branson, US CDC.12

  • References

    1. Gürtler L, Mühlbacher A, Michl U, Hofmann H, Paggi GG, Bossi V, Thorstensson R, G-Villaescusa R, Eiras A, Hernandez JM, Melchior W, Donie F, Weber B. Reduction of the diagnostic window with a new combined p24 antigen and human immunodeficiency virus antibody screen assay. J Virol Methods. 1998 Nov;75(1):27-38.
    2. Burst S, Duttmann H, Feldner J, Gürtler L, Thorstensson R, Simon F. Shortening of the diagnostic window with a new combined HIV p24 antigen and antibody HIV1/2/O screening test. J Virol Methods. 2000 Nov;90(2):153-65.
    3. Pilcher C, Louie B, Keating S, Pandori M, Fish F, Keren T, Lebedeva M, Liska S, Busch M, Hecht F. A clinical study of antigen/antibody rapid testing for acute HIV infection. Poster session presented at: CROI 2009. 16th Conference on Retroviruses and Opportunistic Infections; 2009 Feb 8-11; Montreal, Canada.
    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, Joaki G, Hoffman IF, Martinson FE, Mapanje C, Stewart PW, Powers KA, Galvin S, Chilongozi D, Gama S, Price MA, Fiscus SA, Cohen MS. 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, Tien HC, Eron JJ Jr, Vernazza PL, Leu SY, Stewart PW, Goh LE, Cohen MS. Brief but efficient: acute HIV infection and the sexual transmission of HIV. J Infect Dis. 2004 May 15;189(10):1785-92.
    7. Marks G, Crepaz N, Janssen RS. Estimating sexual transmission of HIV from persons aware and unaware that they are infected with the virus in the USA. AIDS. 2006 Jun 26;20:1447-50.
    8. Avert: Averting HIV and AIDS [Internet]. [UK]: Avert; 2011 [cited 2012 April 26]. Available from www.avert.org.
    9. Global HIV AIDS Response: Progress Report 2011 [Internet]. Geneva: WHO, UNAIDS and UNICEF; 2011 Nov. Page 78, [cited 2012]. Available from http://www.who.int/hiv/pub/progress_report2011/hiv_full_report_2011.pdf.
    10. Smit E, Atherton C, Osman H. Determine HIV-1/2 Ag/Ab Combo lacks sensitivity in detecting early HIV infections. Paper presented at: ESCV 2011. Proceedings of the European Society for Clinical Virology (ESCV) Winter Meeting; 2011 Jan 13-15; London, England.
    11. Fox J, Dunn H, O’Shea S. Low rates of p24 antigen detection using a fourth generation point of care HIV test. Sex Transm Infect. 2011 Mar;87(2):178-9.
    12. Branson BM, Stekkler JD. Detection of Acute HIV Infection: We Can’t Close the Window. J Infect Dis. 2012 Feb 15;205:521-4.
    13. Rosenberg N, Kamanga G, Phiri S, Nsona D, Pettifor A, Rutstein SE, Kamwendo D, Hoffman IF, Keating M, Brown LB, Ndalama B, Fiscus SA, Congdon S, Cohen MS, Miller WC. Detection of acute HIV infection: a field evaluation of the determine® HIV-1/2 Ag/Ab combo test. J Infect Dis. 2012 Feb 15;205(4):528-34. 

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