To share the full product catalog, please use the product catalog download option from the navigation bar at the top of the page. Architect c4000 clinical chemistry abbott core laboratory. Architect is a trademark of abbott laboratories in various jurisdictions. This package insert must be read carefully before product use. It has also been shown to be applicable in the context of high viral diversity among hiv1 group m.
A leader in rapid pointofcare diagnostics alere is now abbott. Pricelist table of contents eligibility and instrumentation molecular reagents and equipment pricing all pricing effective january 1, 2009 hematology reagents and equipment pricing architect clinical chemistry pricing immunoassay pricing architect, axsym and hiv instrument shipping charges for diagnostic analyzers. To evaluate performance of three fdaapproved hiv tests. Architect hiv agab combo assay is intended to be used as an aid in. The abbott architect hiv agab combo assay abbott combo. Links which take you out of abbott worldwide websites are not under the control of abbott, and abbott is not responsible for the contents of any such site or any further links from such site. United states federal law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory. Performance evaluation of a new fourthgeneration hiv combination antigenantibody assay.
Each unique istat system cartridge contains chemically sensitive biosensors on a silicon chip that are. The geenius hiv12 supplement assay biorad laboratories became available and the multispot hiv1hiv2 rapid test has been discontinued. Performance of an alternative hiv diagnostic algorithm. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by abbott. Quantiferon tb gold plus qft plus elisa package insert. Product approval information is indicated for for the qualitative detection of antibodies to hepatitis c virus antihcv in human serum and plasma specimens. Abbott architect hiv agab combo assay fully automated clia moderate assay insert ortho vitros hiv combo test on the vitros 3600 immunodiagnostic system 48. The architect c 4000 offers a maximum throughput of up to 800 tests per hour. The assay was compared with two reference methods, vidas and elecsys pct assays. Package insert for the fda approved multispot rapid hiv 12 test by biorad. Evaluation of the performance of the abbott architect hiv ag. In addition, the fda approved a revised package insert for the geenius assay. Procedure, assay procedure section of this package insert.
Abbott laboratories, abbot park, il became the first antigenantibody combination assay to be approved by fda. The architect hiv agab 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 architect c 4000 clinical chemistry analyzer demonstrates highquality testing results and rapid stat turnaround time. The opd tablets listed in the reagents section of this package insert. Antihbs, antihbc ii, antihbc igm, antihcv, hiv agab combo, havabigg, havabigm. Stored specimens blinded and sent to abbott for combo testing included hiv antibody positive, western blot confirmed specimens and hiv negative specimens. The importance of early detection is underlined by studies demonstrating increased life expectancy following early initiation of antiviral treatment.
Numerous studies have demonstrated that these peptide antigens stimulate ifn. Package insert for the fda approved multispot rapid hiv12 test by biorad. Additional hiv diagnostic tests have received approval from the food and drug administration fda. Evaluation of the performance of the abbott architect hiv. The architect antihcv assay file must be installed on the architect i system from the architect i assay cdrom prior to performing the assay. Department of microbiology, prince of wales hospital, hong kong, china. Alinity s series is a purposebuilt for blood and plasma screening instrument to help you achieve greater operational efficiency. The architect hiv agab combo assay is intended to be used as an aid in the diagnosis of hiv1hiv2 infection, including acute or primary hiv1 infection. The architect i 2000sr immunoassay analyzer offers a maximum throughput of up to 200 tests per hour. Updated 03152018 1 fdaapproved hiv screening tests for laboratory use only clia moderate or high complexity testsa,b for use with. Acutehivandthevalueof4thgeneration testing printedon. Centers for disease control and prevention cdc recommend screening patients at high risk at least once per year with an fdaapproved antigenantibody combination immunoassay that detects hiv 1 and hiv 2 antibodies and the hiv 1 p24 antigen.
Architect antihcv intended use the architect antihcv assay is a. Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert name abbott realtime hiv 1 iended usent the abbott realtime hiv 1 assay is an in vitro reverse transcription. Quantiferon tb gold plus qftplus elisa package insert 022016 5 the antigens used in qftplus are a peptide cocktail simulating the proteins esat6 and cfp10. The abbott architect system is a fully automated random access. To compare performance of three fdaapproved hiv agab combination tests. The elecsys hiv combi pt assay is a fourthgeneration antigenantibody combination. Occurrence of false positivity in a fourth generation ag. Abbott architect cortisol reagent package insert, abbott laboratories, abbott park, il. The abbott prismnext system is a fully automated immunoassay analyzer designed to screen blood using chemiluminescent immunoassay technology. Vidas hiv panel, 4th generation hiv screening biomerieux. The architect core assay is a chemiluminescent microparticle immunoassay cmia for the qualitative detection of igg.
Package insert instructions must be followed accordingly. Check with your local representative for availability in specific markets. Jun 17, 2012 the comparator assays used, namely the abbott architect hiv agab combo, abbott axsym hiv agab combo, abbott prism hiv o plus, and siemens advia centaur hiv agab combo assays, are registered with european notified bodies and represent stateoftheart hiv screening assays. Refer to the materials provided section of this package insert. The architect i sr immunoassay analyzer meets your laboratorys high standards by delivering stat results when you need them. Fdaapproved hiv screening tests for laboratory use only clia moderate or high complexity testsa,b for use with. Lipidmcc contains one level of the four analytes in a lyophilized human serumbased matrix.
Fdaapproved hiv screening test for laboratory use only cdc. Determine the performance of an hiv testing algorithm that uses the architect combo. Architect hiv agab combo abbott laboratories, advia centaur hiv combo siemens healthcare diagnostics and bioplex hiv combo biorad laboratories using genetically diverse hiv samples and clinical specimens. Abbott prism hiv o plus food and drug administration. Human immunodeficiency virus hiv p24 antigen and antibodies to hiv type 1 hiv 1 group m and group o andor type 2. You are about to exit for another abbott country or region specific website. Occurrence of false positivity in a fourth generation agab. Abbott realtime hiv1 assay is broader in terms of range of hiv groups covered 10, however. Field evaluation of the abbott architect hiv agab combo. Jun 17, 2012 education and diagnostic tests capable of early detection represent our most effective means of preventing transmission of human immunodeficiency virus hiv. A leader in rapid pointofcare diagnostics alere is now. Use of rapid hiv assays as supplemental tests in specimens with repeatedly reactive screening immunoassay results not con. This package insert must be read carefully prior to use. Stored specimens blinded and sent to abbott for combo testing included hiv antibody positive, western blot.
The vidas hiv panel provides a combination of advanced 4 th generation assays for improved detection of acute hiv during the critical window period. The architect hiv agab combo assay is not intended for use in screening. Abbott diagnostics personalized solutions for better. The assay may also be used as an aid in the diagnosis of hiv1hiv2 infection in pediatric subjects i. The 2018 laboratory guidelines include the following. The architect hiv agab combo assay is a chemiluminescent. Pro3019 architect hiv abag combo eia evaluation report architect hiv abag combo eia performance evaluation report by the health protection agency, evaluation and standards laboratory, london. Assays were performed according to manufacturers package insert. Please be aware that the website you have requested is intended for the residents of a particular country or region, as noted on that site. Abbott diagnostics division en hiv agab combo 4j27 483504r4 b4j270 read highlighted changes revised february, 2009 hiv agab combo customer service for additional product information, please contact your local customer service organization. Diagnostics safety data sheets sds united states and international. For the detection of antibodies to hiv1 antihiv1 groups m and o andor antibodies to hiv2 antihiv2 in human serum and plasma specimens product information package insert abbott prism. Abbott diagnostics division en antihcv 6c37 486176r6 b6c370 read highlighted changes.
Comparison of a new automated abbott architect procalcitonin. The architect c 4000 enhances laboratory productivity and provides users high confidence in clinical results. Comparative evaluation of three fdaapproved hiv agab. Architect hiv agab combo uses antihiv 1 p24 antibodies as reagents to detect hiv 1 p24 antigen and detects antibodies to hiv 1 groups m and o, and hiv 2 through the use of five recombinant proteins and two synthetic peptides derived from native tmp sequences of hiv 1 groups m and o, and hiv 2. Intended use the architect hiv agab combo controls. Manufacturer of the istat system, a handheld blood analyser for withpatient testing aimed at improving the quality, cost, and operational efficiency of health. For other specimen type refer to each assay package insert. Testing of cadaveric blood specimens from patients with plasma dilution due to transfusions of 2000ml of blood or colloids within 48 hours, or 2000ml of crystalloids within 1 hour or any. Fast, reliable results with abbott architect assays. Architect hiv combo abbott, advia centaur hiv combo siemens and bioplex. Abbott diagnostics division en rhtlviii 6l61 84 6470r2 b6l610 rhtlviii customer service for additional product information, please contact your local customer service organization. Abbott hiv12 hivab rdna eia package, package insert and other fda. Key to symbols used list number in vitro diagnostic medical.
The measuring intervals of the three assays differed, with the architect from 0. All human sourced materials were tested and found to be nonreactive for hilsag, antihbc, antihcv, hcv rna or hcv ag, anti hiv li hiv 2, hiv 1i ag or. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert name abbott realtime hiv1 iended usent the abbott realtime hiv1 assay is an in vitro reverse transcription. Performance evaluation of a new fourthgeneration hiv. All human sourced materials were tested and found to be nonreactive for hilsag, antihbc, antihcv, hcv rna or hcv ag, anti hivlihiv2.
Fdaapproved hiv screening test for laboratory use only. Abbott architect cortisol reagent package insert, abbott. Architect hiv agab reagent package insert, approved by fda june 2010. The flexible protocols built into the architect i sr enhance laboratory workflow and allow you to report results with confidence. The abbott realti m e hiv1 viral load assay is for quantitation of human immunodeficiency virus 1 hiv1. Assays were performed and interpreted according to the. Hiv12 antigen and antibodies fourth generation, with re. To assess the falsepositive and falsenegative rates of a 4thgeneration human immunodeficiency virus hiv assay, the abbott architect, vs 2 hiv 3rdgeneration assays, the siemens centaur and. In this study, the performance of the new automated abbott architect pct assay was evaluated. Follow the abbott diagnostics linkedin channel for the latest news from our company and within the in vitro diagnostics industry. Architect i2000sr immunoassay abbott core laboratory. Featuring a loadup capacity of 5 samples with 35 priority and 100 routine areas, the architect i 2000sr has 25 refrigerated reagent positions. Comp inc, hudson, ohio, pp 154155 caliper reference range study on abbott architect. Assessment of the ability of a fourthgeneration immunoassay for human immunodeficiency virus hiv antibody and p24 antigen to detect both acute and recent hiv infections in a high risk setting.
Comparison of detection limits of 4th generation combination hiv. Cancer afp ca 125 ca 153 ca 199 xr cea free psa he4 total psa cardiac bnp ckmb galectin3 myoglobin troponini fertilitypregnancy dheas estradiol fsh hcg total. Abbotts architect hiv agab combo assay is a fourth generation test that simultaneously screens for both types of hiv antibodies type 1 and type 2 and hiv1 p24 antigen using a blood sample from the patient. The architect hiv agab combo assay has a wide dynamic range for determining the sampletocutoff ratio sco values compared to other diagnostic hiv antibody assays. The architect hiv agab combo assay is not intended for use in screening blood, plasma, or. Performance of an alternative hiv diagnostic algorithm using.
Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. Vidas hiv panel advanced 4th generation assays for earlier diagnosis. Centers for disease control and prevention cdc recommend screening patients at high risk at least once per year with an fdaapproved antigenantibody combination immunoassay that detects hiv1 and hiv2 antibodies and the hiv1 p24 antigen. Fdaapproved hiv screening test for laboratory use only clia. Comparison of a new automated abbott architect procalcitonin assay with biomerieux vidas and roche elecsys methods. For detailed information on assay file installation and viewing and editing assay parameters, refer to the architect system operations manual, section 2. A product guide for pointofcare cd4 tests and laboratorybased and pointofcare hiv and hcv viral load tests1 table of contents 2 introduction table of contents 3 msf and hiv diagnostic and monitoring tools 4 snapshot of implementation of hiv testing guidelines 4 updated global fund tender on eid and viral load. Committed to provide solutions that drive innovation across the blood and plasma service.