Intended Use and Important Safety Information
ARCHITECT is a trademark of Abbott Laboratories. The ARCHITECT HIV Ag/Ab Combo assay is a chemiluminescent microparticle immunoassay (CMIA) for the simultaneous qualitative detection of human immunodeficiency virus (HIV) p24 antigen and antibodies to HIV type 1 (HIV-1 group M and group O) and/or type 2 (HIV-2) in human serum and plasma (EDTA and heparin). The ARCHITECT HIV Ag/Ab Combo assay is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. The assay may also be used as an aid in the diagnosis of HIV-1/HIV-2 infection in pediatric subjects (i.e., children as young as two years of age) and in pregnant women. An ARCHITECT HIV Ag/Ab Combo reactive result does not distinguish between the detection of HIV p24 antigen, HIV-1 antibody, or HIV-2 antibody.
The ARCHITECT HIV Ag/Ab Combo is not intended for use in screening blood or plasma donors. The effectiveness of ARCHITECT HIV Ag/Ab Combo for use in screening blood or plasma donors has not been established. However, this assay can be used as a blood donor screening assay in urgent situations where traditional licensed blood donor screening tests are unavailable or their use is impractical.
This product requires the handling of human specimens. Human sourced materials should be considered potentially infectious and handled in accordance with the OSHA Standards. This product contains sodium azide: material and its container must be disposed of in a safe way. Assay results should be interpreted in conjunction with the patient's clinical presentation, history, and other laboratory results. If the results are inconsistent with clinical evidence, additional testing is suggested to confirm the result. The performance of this assay has not been established for individuals younger than two years of age.
Terms and Conditions
This is an interactive model. The calculations within this tool may be based upon a number of sources, including but not limited to: scientific literature, commercially available data sets, data/ inputs provided by the customer, and various external sources.
Estimates resulting from the tool are for illustrative purposes only. This tool is not intended for any other purpose.
It should also be noted that there are usually differences between modelling potential estimates and actual results. Abbott does not take responsibility for any such discrepancies. There is no guarantee of the potential savings indicated. Actual savings are dependent on many factors and will vary.
This tool is expressly not to be distributed to third parties.
ACCEPT
ARCHITECT HIV Ag/Ab
Acute HIV and the value of 4th generation testing
HIV infection affects more than 1.2 million people in the United States
1
- Prevalence of Diagnosed and Undiagnosed HIV Infection - United States, 2008-2012
U.S. Centers for Disease Control and Prevention
Morbidity and Mortality Weekly Report (MMWR). 2015;64(24);657-662(June 26, 2015)
IN GEORGIA
an estimated
706 of every 100,000 people are living with HIV infevtion (diagnosed or undiagnosed).
This translates into
57,300 cases.
1
- Prevalence of Diagnosed and Undiagnosed HIV Infection - United States, 2008-2012
U.S. Centers for Disease Control and Prevention
Morbidity and Mortality Weekly Report (MMWR). 2015;64(24);657-662(June 26, 2015)
Source: June 26, 2015 CDC Morbidity and Mortality Weekly Report (MMWR)
1
- Prevalence of Diagnosed and Undiagnosed HIV Infection - United States, 2008-2012
U.S. Centers for Disease Control and Prevention
Morbidity and Mortality Weekly Report (MMWR). 2015;64(24);657-662(June 26, 2015)
Estimated number of persons aged >= 13 years with HIV infection (diagnosed and undiagnosed), United Staets, 2012
ARCHITECT HIV Ag/Ab
Acute HIV and the value of 4th generation testing
Fourth-generation laboratory tests can detect HIV earlier, when it is in the acute phase and highly infectious
5
- HIV testing: an update
Marquez, C.; Zetola, N. M.; Klausner, J. D.
2008;40(2):12-4, 16, 18 passim
FOURTH-GENERATION IMMUNOASSAY TESTS CAN
Identify HIV up to 20 days earlier than other test methods
4
- Architect HIV Ag/AB Reagent Package Insert Approved by FDA June 2010, pg16.
Abbott
2010
Intended use and important safety information
The ARCHITECT HIV Ag/Ab Combo assay is a chemiluminescent microparticle immunoassay (CMIA) for the simultaneous qualitative detection of human immunodeficiency virus (HIV) p24 antigen and antibodies to HIV type 1 (HIV-1 group M and group O) and/or type 2 (HIV-2) in human serum and plasma (EDTA and heparin). The ARCHITECT HIV Ag/Ab Combo assay is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. The assay may also be used as an aid in the diagnosis of HIV-1/HIV-2 infection in pediatric subjects (i.e., children as young as two years of age) and in pregnant women. An ARCHITECT HIV Ag/Ab Combo reactive result does not distinguish between the detection of HIV p24 antigen, HIV-1 antibody, or HIV-2 antibody.
The ARCHITECT HIV Ag/Ab Combo is not intended for use in screening blood or plasma donors. The effectiveness of ARCHITECT HIV Ag/Ab Combo for use in screening blood or plasma donors has not been established. However, this assay can be used as a blood donor screening assay in urgent situations where traditional licensed blood donor screening tests are unavailable or their use is impractical.
This product requires the handling of human specimens. Human sourced materials should be considered potentially infectious and handled in accordance with the OSHA Standards. This product contains sodium azide: material and its container must be disposed of in a safe way. Assay results should be interpreted in conjunction with the patient's clinical presentation, history, and other laboratory results. If the results are inconsistent with clinical evidence, additional testing is suggested to confirm the result. The performance of this assay has not been established for individuals younger than two years of age.
ARCHITECT HIV Ag/Ab
Acute HIV and the value of 4th generation testing
HOW MANY PEOPLE MIGHT BE IDENTIFIED EARLIER IN YOUR HEALTH SYSTEM?
Studies have found up to 10% of all HIV infections in a tested population are in the acute phase, where an antibody-only assay would not likely identify them.
6-9
- Detection of acute HIV infections in high-risk patients in California
Patel, P.; Klausner, J. D.; Bacon, O. M.; et al.
2006;42(1):75-9 - Detection of acute infections during HIV testing in North Carolina
Pilcher, C. D.; Fiscus, S. A.; Nguyen, T. Q.; et al.
2005;352(18):1873-83 - HIV testing in a high-incidence population: is antibody testing alone good enough?
Stekler, J. D.; Swenson, P. D.; Coombs, R. W.; et al.
2009;49(3):444-53 - Identification of Acute HIV Infection Using Fourth-GenerationTesting in an Opt Out Emergency Department Screening Program
Kara I.Geren, MD, MPH; Frank Lovecchio, DO, MPH; Jason Knight, MD; et al.
Annals of Emergency Medicine. 2014
For the estimated population of 2,080 undiagnosed cases of HIV in Fulton County
10
% acute cases could translate into up to
208
HIV-position atients which might be missed with antibody-only
Percentage acute HIV cases:
This level of acute infection has not been reported in the referenced published studies
Estimated acute cases:2,080 potentiall undiagnosed casesin Fulton County * 10% (estimated percentage of HIV infections in the acute phase
6-9
- Detection of acute HIV infections in high-risk patients in California
Patel, P.; Klausner, J. D.; Bacon, O. M.; et al.
2006;42(1):75-9 - Detection of acute infections during HIV testing in North Carolina
Pilcher, C. D.; Fiscus, S. A.; Nguyen, T. Q.; et al.
2005;352(18):1873-83 - HIV testing in a high-incidence population: is antibody testing alone good enough?
Stekler, J. D.; Swenson, P. D.; Coombs, R. W.; et al.
2009;49(3):444-53 - Identification of Acute HIV Infection Using Fourth-GenerationTesting in an Opt Out Emergency Department Screening Program
Kara I.Geren, MD, MPH; Frank Lovecchio, DO, MPH; Jason Knight, MD; et al.
Annals of Emergency Medicine. 2014
)
= 208 potentially undiagnosed cases
ARCHITECT HIV Ag/Ab
Acute HIV and the value of 4th generation testing
WHAT ABOUT COSTS?
Timely diagnosis and treatment of HIV can lead to health economic benefits
10-13
- Prevention of HIV-1 infection with early antiretroviral therapy
Cohen, M. S.; Chen, Y. Q.; McCauley, M.; et al.
2011;365(6):493-505 - The economic burden of late entry into medical care for patients with HIV infection
Fleishman, J. A.; Yehia, B. R.; Moore, R. D.; et al.
2010;48(12):1071-9 - Early initiation of antiretroviral therapy and associated reduction in mortality, morbidity and defaulting in a nurse-managed, community cohort in Lesotho
Ford, N.; Kranzer, K.; Hilderbrand, K.; et al.
2010;24(17):2645-50 - HIV Cost-effectiveness
U.S. Centers for Disease Control and Prevention
2010
ACUTE CARE LIFETIME
COST REDUCTION
DECREASE
TRANSMISSION WITH
HAART THERAPY
$379,668
ESTIMATE LIFETIME COST OF HIV CARE*
* For adults who initiate ART with CD4 cell counts<350uL