Pdf performance of the abbott realtime hiv1 viral load. Bp0600020, abbott realtime hiv1 amplification reagent. Who prequalification of diagnostics programme public report. Abbott realtime hiv1 amplification reagent kit, abbott. Request pdf abbott realtime hiv1 m2000rt viral load testing. Allowing consolidation of pcr testing on a single, reliable, high performance platform. Abbott m2000sp liquid handler w m2000rt pcr unit2 bostonind 12301 duration. Abbott realtime hiv1 iended usent the abbott realtime hiv1 assay is an in vitro reverse transcriptionpolymerase chain reaction rtpcr assay for the quantitation of human immunodeficiency virus type 1 hiv1 on the automated m2000 system in human plasma from hiv1 infected individuals over the range of 40 to 10,000,000 copiesml. Sep 04, 2017 abbott m2000sp liquid handler w m2000rt pcr unit2 bostonind 12301 duration. The abbott realtime human immunodeficiency virus type 1 hiv1 assay art and the cobas ampliprepcobas taqman hiv1 test ctm are commercially.
In total, 169 blood samples with detectable plasma hiv1 rna were used to extract rna from paired dbs and liquid plasma samples, using the automated abbott m sample. The abbott realtime hiv 1 calibrators are for calibration of the abbott realtime hiv 1 assay when used for the quantitative determination of human immunodeficiency virus type 1 hiv 1 rna in human plasma from hiv 1 infected individuals. Nov 28, 2019 comparison of hiv 1 viral load between abbott m2000 and roche cobas taqman methods. Performance of the abbott realtime hiv 1 viral load assay is not impacted by integrase inhibitor resistanceassociated mutations. 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. Pdf comparative evaluation of the performance of the. Newer realtime vl testing technologies are faster and have larger dynamic ranges and fully automated extraction to benefit higher throughputs in resourcepoor environments. The abbott realtime hiv 1 manual assay is an in vitro reverse transcriptionpolymerase chain reaction rtpcr assay for the quantitation of human immunodeficiency virus type 1 hiv 1 in human plasma from hiv 1 infected individuals. Pdf evaluation of the abbott m2000rt realtime hiv1 assay. A pcr test that detects hiv 1 nucleic acids from human plasma and dried blood spots dbs.
Comparative evaluation of the performance of the abbott realtime hiv1 assay for measurement of hiv1 plasma viral load on genetically diverse samples from greece. Food and drug administration fda for in vitro quantification of hiv 1 rna in human plasma. Comparison of hiv1 viral load between abbott m2000 and roche cobas taqman methods. The implementation of antiretroviral therapy demands the need for increased access to viral load vl monitoring. Newer realtime vl testing technologies are faster and have larger dynamic ranges and fully automated extraction to benefit higher. The specificity of the realti m e hiv1 assay was evaluated by testing 189 hiv1 seronegative plasma specimens. The abbott realtime hiv1 assay was evaluated for its performance in quanti. Intotal,169blood samples with detectable plasma hiv1 rna were used to extract rna from paired dbs and liquid plasma samples, using the auto. The abbott realti m e hiv1 assay is an in vitro reverse transcriptionpolymerase chain reaction rtpcr assay for the quantitation of human immunodeficiency virus type 1 hiv1 on the automated m 2000 system in human plasma from hiv1 infected individuals over the range of 40 to 10,000,000 copiesml. Asr analyte specific reagent analytical and performance characteristics are not established gpr general purpose reagent ivd in vitro diagnostics rx only ruo research use only. In this study, the abbott realtime hiv 1 abbott realtime assay was compared to the roche cobas taqman hiv 1 cobas taqman and the siemens versant hiv 1 rna 3. The limit of detection was determined using the second international world health organization standard and viral quality assurance. M2000sp abbott pdf name of instrument, m realtime system composed of the msp and mrt modules.
Mar 19, 2018 summary of safety and effectiveness abbott realtime hiv1 amplification reagent kit, abbott realtime hiv1 calibrator kit, abbott realtime hiv1 control kit pdf 175kb contact fda 800 8354709. Evaluation of the abbott realtime hiv1 quantitative. The abbott realti m e human immunodeficiency virus type 1 hiv1 assay was evaluated as a new option. Availability of laboratory defined applications lda the m 2000 system gives todays labs the consistency and the confidence they need all on. Abbott realtime hiv 1 iended usent the abbott realtime hiv 1 assay is an in vitro reverse transcriptionpolymerase chain reaction rtpcr assay for the quantitation of human immunodeficiency virus type 1 hiv 1 on the automated m2000 system in human plasma from hiv 1 infected individuals over the range of 40 to 10,000,000 copiesml.
Hiv 1 group m and group o andor hiv 2 in human serum and plasma edta and heparin intended to be used as an aid in the diagnosis of hiv 1 hiv 2 infection, including acute or primary infection an architect hiv agab combo reactive result does not distinguish between the detection of hiv 1 p24 antigen, hiv 1 antibody, or hiv 2 antibody. The abbott realtime hiv1 assay is a realtime nucleic acid amplification assay available for hiv1 viral load quantitation. Pdf measurement of viral load by the automated abbott. Both plasma and dbs specimens were prepared and tested for hiv1 vl with the roche capctm hiv1 test v2. The abbott realtime hiv1 qualitative is an in vitro amplification assay for the qualitative detection of human immunodeficiency virus type 1 hiv1 nucleic acids from human plasma and dried blood spots dbs. Multicenter evaluation of the new abbott realtime assays for. E realtime hiv1 6l18 51602146r2 abbott realtime hiv1 customer service. Food and drug administration fda for the fastest available molecular pointofcare test for the detection of novel coronavirus covid19, delivering positive results in as little as five minutes and negative results in minutes what makes this test so different is where it can be used. The abbott realtime hiv1 qualitative is not intended to be used as a donor screening test for hiv1. Abbott moleculars m2000 system and realtime hiv 1 assay realtime were evaluated for sensitivity, reproducibility, linearity, ability to detect diverse hiv 1 subtypesgroups, and correlation to the roche amplicor hiv 1 monitor test, version 1. In short, hiv1 rna and hcv rna were isolated from 1. The assay has a platform for automated extraction of viral rna from plasma or dried blood spot samples, and an amplification platform with real time fluorescent detection.
Evaluation of the abbott realtime hiv1 quantitative assay. A realtime hiv 1 viral load assay for automated quantitation of hiv 1 rna in genetically diverse group m subtypes ah, group o and group n samples. Hiv 1 rna and hiv 2 rna assays are offered to confirm hiv 1 orand hiv 2 infections for patient samples with undifferentiated hiv antibody status and to monitor antiretroviral therapy. Hiv1 group m and group o andor hiv2 in human serum and plasma edta and heparin intended to be used as an aid in the diagnosis of hiv1hiv2 infection, including acute or primary infection an architect hiv agab combo reactive result does not distinguish between the detection of hiv1 p24 antigen, hiv1 antibody, or hiv2 antibody. In short, hiv 1 rna and hcv rna were isolated from 1. Pdf hiv1 viral load measurement in venous blood and. Pqdx 008302700 abstract the abbott realtime hiv 1 m24sp assay with product code 2g31 which includes 2g3190, 2g3180, 2g3170 manufactured by abbott molecular inc. Food and drug administration abbotts realtime hiv1 quantitative assay received ce mark for driedbloodspot testing and was accepted for the world health organizations list of prequalifi ed diagnostics. A pcr test that detects hiv1 nucleic acids from human plasma and dried blood spots dbs. In this study, the abbott realtime hiv1 abbott realtime assay was compared to the roche cobas taqman hiv1 cobas taqman and the siemens versant hiv1 rna 3. The material is also tested and found to be negative by fda licensed pcr methods for hiv1 rna and hcv rna. The abbott realtime hiv1 assay is not intended to be used as a screening test for hiv1 or as a diagnostic test to confirm the presence of hiv1 infection. The abbott realtime hiv1 manual assay is an in vitro reverse transcriptionpolymerase chain reaction rtpcr assay for the quantitation of human immunodeficiency virus type 1 hiv1 in human plasma from hiv1 infected individuals.
Abbott has received emergency use authorization eua from the u. If the abbott m2000sp master mix addition protocol is aborted, seal the abbott. The abbott realtime hiv1 qualitative manual with product code 4n6690, manufactured by abbott molecular inc. The specificity of the realtime hiv1 assay was evaluated by testing 189 hiv1 seronegative plasma specimens. The analytical performance of this new assay was compared to the fda. Abbott molecular support guide sg06l18, rev 002 internal use only page 1 of 69 abbott molecular support guide abbott realtime hiv1 assay realtime reagents manufactured and distributed by abbott molecular inc. Rnai strategies against single genotypes or against variable regions of the genome would need to have significant other advantages to be part of robust therapies. Public report for abbott realtime hiv1 m24sp slidelegend. Who prequalification of diagnostics programme public. Reading the abbott realtime hiv1 assay result file into ldms.
Evaluation of performance across the dynamic range of the abbott realtime hiv1 assay as compared to versant hiv1 rna 3. Abbotts zika molecular diagnostics test received emergency use authorization from the u. Pdf performance of the automated abbott realtime hiv1. Comparative evaluation of the performance of the abbott realtime hiv1 assay for measurement of hiv1 plasma viral load on genetically diverse samples from. Hiv1 rna was not detected, resulting in 100% 189189. Duallabeled fluorescent probes for hiv 1 and hiv 1 qsspecific oligonucleotides were used, each labeled with different reporter dyes and a quencher dye.
Hiv 1 is characterized by increased genetic heterogeneity which tends to hinder the reliability of detection and accuracy of hiv 1 rna quantitation assays. The abbott m2000 realtime system is a highly flexible and proven solution featuring a broad menu of ivd assays. The abbott realtime hiv1 assay was evaluated for its performance in quantification of human immunodeficiency virus type 1 hiv1 rna in dried blood spot dbs samples. You are about to exit for another abbott country or region specific website.
Abbott molecular support guide sg06l18, rev 002 internal use only page 1 of 69 abbott molecular support guide abbott realtime hiv 1 assay realtime reagents manufactured and distributed by abbott molecular inc. The abbott realtime hiv 1 and hcv viral load assays were performed according to the instructions provided by abbott molecular. Abbott molecular m2000sp liquid handler realtime m2000. Pdf comparative evaluation of the performance of the abbott. Abbott realtime hiv1 qualitative is an in vitro realtime pcr assay for detecting hiv1. Dbs sample collection for early infant diagnosis eid by pcr. Performance of the automated abbott realtime hiv1 assay on a genetically diverse panel of specimens from london. 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. We compared the abbott m2000 realtime abbott hiv1 assay with the roche amplicor monitor v1. The abbott realtime hiv1 calibrators are for calibration of the abbott realtime hiv1 assay when used for the quantitative determination of human immunodeficiency virus type 1 hiv1 rna in human plasma from hiv1 infected individuals. The abbott realtime hiv1 and hcv viral load assays were performed according to the instructions provided by abbott molecular. The abbott realtime hiv1 assay with dbs sample protocol provides an alternative sample collection and transfer option in resourcelimited settings and expands the utility of a viral load test to. The abbott realtime hiv1 assay is an in vitro reverse transcription.
Performance of the abbott realtime hiv1 viral load assay is not impacted by integrase inhibitor resistanceassociated mutations. In the study described here, we investigated and compared the performance of the abbott diagnostics abbott park, il realtime hiv type 1 hiv 1 assay abbreviated realtime hiv 1 on the m2000spm2000rt automated extraction platform abbott molecular inc. Hiv rna and antigen panel member abbott realtime hiv1 rna m2000 cml1 roche cobas ampliprep cobas taqman hiv1 test v2. Apr 05, 2020 the performance of abbott realtime hbv quantification kit was excellent. A realtime hiv1 viral load assay for automated quantitation of hiv1 rna in genetically diverse group m subtypes ah, group o and group n samples. The objective of this study was to evaluate the feasibility of using the abbott realtime hiv1 assay to quantify hiv1 rna load in dbs samples, as compared with liquid plasma samples, in an italian test population. 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.
Device description the abbott realtime hiv1 assay is an in vitro reverse transcriptasepolymerase chain reaction assay for the quantitative detection of hiv1 rna in human plasma from hiv1. Abbott realtime hiv1 qualitative world health organization. Pdf evaluation of the abbott m2000rt realtime hiv1. Abbott realtime hiv1 amplification reagent kit ivd, 4 packs, 24 tests each. Pqdx 008302700 abstract the abbott realtime hiv1 m24sp assay with product code 2g31 which includes 2g3190, 2g3180, 2g3170 manufactured by abbott molecular inc. Manual extraction versus the automated m2000sp extraction the abbott realtime hiv1 assay is a realtime nucleic acid. Acute hiv 1 infections are confirmed with the hiv 1 rna assay abbott realtime hiv 1 assay. Diagnostics safety data sheets sds united states and international. Abbott realtime hiv1 package insert abbott molecular. Evaluation of the abbott investigational use only realtime. All vl assays were performed according to the manufacturers instructions following product inserts aptima hiv1 quant dx assay aptima by hologic, inc. Evaluation of the abbott m2000 realtime human immunodeficiency virus type 1 hiv1 assay for hiv load monitoring in south africa compared to the roche cobas ampliprep. Summary of safety and effectiveness abbott realtime hiv1 amplification reagent kit, abbott realtime hiv1 calibrator kit, abbott realtime hiv1 control kit pdf. Summary of safety and effectiveness abbott realtime hiv1 amplification reagent kit, abbott realtime hiv1 calibrator kit, abbott realtime hiv1 control kit pdf 175kb contact fda 800 8354709.
Apr 10, 2020 the abbott realtime sarscov2 assay is performed on the abbott m2000 system consisting of a sample preparation unit, the abbott m2000sp, and an amplification and detection unit, the abbott m2000rt. The evaluation was performed using 220 clinical plasma samples, the who 3rd hiv. Art is performed on an integrated m2000spm2000rt instrument system abbott. Bp0600020, abbott realtime hiv1 amplification reagent kit. Pqdx 008302700 who pqdx pr november2011, version 2. Comparison of the abbott m2000 hiv1 realtime and roche.
In total, 169 blood samples with detectable plasma hiv1 rna were used to extract rna from paired dbs and liquid plasma samples, using the automated abbott m sample preparation system m2000sp. Abbott molecular m2000sp liquid handler realtime m2000 works. Detect covid19 in as little as 5 minutes abbott newsroom. The abbott realtime hiv1 qualitative is intended to be used as an aid in the diagnosis of hiv1 infection in pediatric and adult subjects. The dualtarget approach in viral hiv1 viremia testing. The abbott realtime hiv 1 assay is an in vitro reverse transcriptionpolymerase chain reaction rtpcr assay for the quantitation of human immunodeficiency virus type 1 hiv 1 on the automated m2000 system in human plasma from hiv 1 infected individuals over the range of 40 to 10,000,000 copiesml. Abbott real time hiv1 roche cobas ampliprepcobas taqman hiv1 ver. The assay may also be used as an aid in the diagnosis of hiv 1 hiv 2 infection in pediatric subjects i. The abbott realti m e idh2 m 2000 rt application cdrom, version 1. This material has been developed for internal use and is not approved for external distribution. Abbott m system users and manual sample preparation method users manually combine the abbott realtime hiv1 amplification reagent components to. Comparative evaluation of the performance of the abbott. Abbott realti m e idh2 m 2000 rt application cdrom, version 1. Abbott realtime hiv1 calibrator kit abbott realtime hiv1 control kit.
Table of contents abbott realtime hiv1 pma bp060002. Multicenter evaluation of the new abbott realtime assays. Three hundred and eleven plasma samples were tested, including 164 samples from patients on art. The abbott realtime hiv1 amplification reagent pack and internal control vials must be stored at. 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.
Intended use the abbott realti m e idh2 m 2000 rt application cdrom, version 1. The abbott realtime sarscov2 assay test is a realtime reverse transcriptionpolymerase chain reaction qrtpcr done on the abbott m2000 system. Request pdf evaluation of the abbott realtime hiv1 quantitative assay with dried blood spot specimens the abbott realtime hiv1 assay was evaluated for its performance in quantification of. The primer and the test probe are designed to detect sarscov2 rna from a specimen collected from suspected cases of covid19. Results of the abbott realtime hiv1 assay for specimens. Application parameters specific to the abbott realtime sarscov2 assay are contained on an assayspecific application specification file. Abbott realtime hiv1 assay referenznummer faamaug2017. Intotal,169blood samples with detectable plasma hiv1 rna were used to extract. E realtime hiv 1 6l18 51602146r2 abbott realtime hiv 1 customer service.
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