Background: As of 2010, an estimated 1.1 million persons in the United States were living with human immunodeficiency virus (HIV) infection, of whom an estimated 181,000 were unaware of their infection.1 Approximately, 49,000 new HIV diagnoses are reported to CDC each ear, and the estimated number of new infections has remained stable at approximately 50,000 annually from 2008 to 2010.2,3 As of 2009, an estimated 83 million adults aged 18 to 64 years reported they had been tested for HIV.4 Accurate laboratory diagnosis of HIV is essential to identify persons who could benefit from treatment, to reassure persons who are uninfected, and to reduce HIV transmission.5

Evolution of HIV Immunoassay Technology

“The risk of HIV-1 transmission from persons with acute and early infection is much higher than that from persons with established infection.”6

HIV-1/2 5TH GEnEraTIon - TEsT #10634

What is HIV-1/2 5th Generation? HIV 5th generation assay simultaneously detects and differentiates HIV-1 p24 antigen, antibodies to HIV-1 (groups M and O) and antibodies to HIV-2 in human serum. Detection of HIV-1 antigen, allows clinicians to distinguish patients with early infections. HIV marker identification enables clinicians to promptly respond with a tailored treatment and control the spread of the virus.

Why HIV-1/2 5th Generation?The 5th Generation HIV Ag-Ab assay simultaneously detects and reports:

HIV Ag-Ab overall result with:• HIV-1 p24 antigen• HIV-1 antibodies (groups M & o) & HIV-2 antibodies

Overall Performance• High diagnostic sensitivity:

100% sensitivity in known HIV-1 and HIV-2 positive samples• Best analytical sensitivity for HIV-1 p24 antigen:

0.33 IU/mL (WHO standard), 5.2 pg/mL (AFSSAPS standard)• High specificity of 99.86%• Excellent HIV-1/HIV-2 ab differentiation capability:

Differentiation rate of 100% in HIV-1 populations and 93.5% in HIV-2 populations

• Approved for organ donor screening

Who can be tested?Anyone suspected of having HIV infection.

specimen requirements: Submit one (1) dedicated SST.

Transport/stability: Room temperature specimen is stable for 4 days. Refrigerated specimen is stable for 7 days. Grossly hemolyzed or lipemic specimen will be rejected.references:

1. CDC. Monitoring selected national HIV prevention and care objectives by using HIV surveillance data — United States and 6 U.S. dependent areas — 2011.

HIV Surveillance Supplemental Report. 2013;18(No. 5).

2. CDC. HIV Surveillance Report, 2011. 2013;23. http://www.cdc.gov/hiv/pdf/statistics_2011_HIV_Surveillance_Report_vol_23.pdf. Accessed April 1, 2016.

3. CDC. Estimated HIV incidence in the United States, 2007–2010. HIV Surveillance Supplemental Report. 2012;17(4):1-26.

http://www.cdc.gov/hiv/pdf/statistics_hssr_vol_17_no_4.pdf. Accessed April 1, 2016.

4. CDC. Vital signs: HIV testing and diagnosis among adults—United States, 2001-2009. MMWR Morb Mortal

Wkly Rep. 2010;59(47):1550-5. Available at:

http://www.cdc.gov/mmwr/PDF/wk/mm5947.pdf.

5. CDC. Vital signs: HIV prevention through care and treatment—United States. MMWR Morb Mortal Wkly Rep.

2011;60(47):1618-23. Available at:

http://www.cdc.gov/mmwr/PDF/wk/mm6047.pdf.

6. CDC. Laboratory testing for the diagnosis of HIV infection: updated recommendations. June 27, 2014.

Available at: http://stacks.cdc.gov/view/cdc/23447.

1857 86th Street | Brooklyn, NY 11214 Tel: 718-232-1515 | Fax: 718-232-1550

www.lencolab.com