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. One hundred and thirtyfour chb patients who received hbv antiviral therapy were enrolled. Realtime hbv viral load assay abbott molecular contact. Abbott realtime hiv1 m2000sp assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in. Allowing consolidation of pcr testing on a single, reliable, high performance platform. Listing a study does not mean it has been evaluated by the u.
Jun 26, 2019 evaluation of the abbott realtime hbv dna assay and comparison to the cobas ampliprepcobas taqman 48 assay in monitoring patients with chronic. Pdf evaluation of the abbott realtime hbv dna assay and. Availability of laboratory defined applications lda the m 2000 system gives todays labs the consistency and the confidence they need all on. Abbott realtime hbv assay is more sensitive in detection of.
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. We compared the performance of hiv1, hcv and hbv quantification assays on the recently developed abbott alinity m system to the m2000 realtime assays. Listing a study does not mean it has been evaluated by. Parkin,b vera holzmayer,d lilly yuen,e carolyn mullena. The abbott m2000 realtime system is a highly flexible and proven solution featuring a broad menu of ivd assays.
Decreased neonatal hepatitis b virus hbv viremia by. Hbv dna realtime abbott tests result flag units reference interval lab hbv dna realtime abbott hepatitis b quantitation hbv dna not detected iuml 01 hbv log10 unable to calculate result since nonnumeric result obtained for component test 01 test information. Jun 21, 2007 abbott is marketing the test under its strategic alliance with celera. Clinical performance of abbott realtime hepatitis c virus hcv genotype ii test. Manufacturer platform hiv hav hbv hcv std abbott m2000 realtime hiv. This letter highlights important information regarding specimen collection and result interpretation which is relevant for users of these services. A dna sequence that is unrelated to the hbv target sequence is introduced into each specimen at the. Abbott realtimehbv assay is more sensitive in detection of. The abbott realtime sarsc0v2 assay is an emergency use authorization eua test authorized by the u. Abbott is marketing the test under its strategic alliance with celera.
Bp0600020, abbott realtime hiv1 amplification reagent kit. Pdf comparison of the advansure hbv realtime pcr test. 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. Hepatitis b virus hbv dna quantification is necessary for starting and monitoring of antiviral therapy in patients with chronic hepatitis b. Sequence conservation of the region targeted by the abbott realtime hbv viral load assay in clinical specimens gavin a. The realtime cmv assay measures cytomegalovirus cmv dna that may be present in the blood of a patient who has undergone a bone marrow transplant. Abbott realtime hbv assay is more sensitive in detection of low viral load and little impacted by drug resistant mutation in chronic hepatitis b. Abbott diagnostics core laboratory infectious disease assays comprise a comprehensive panel of tests to assess general health in a patient.
Parkin, b vera holzmayer, d lilly yuen, e and carolyn mullen a. Comparison of hbv dna quantitation using the abbott realtime and versant hepatitis b virus assays. Introduction of the abbott realtime hepatitis c and. During the read cycles of amplification on the abbott m2000rt, the temperature is lowered further to allow fluorescent detection of amplification products as the hiv1 and ic probes anneal to their targets realtime fluorescence detection. The quantitation of human hepatitis b virus hbv in the serum of infected patients is recommended to characterize the course of chronic hbv infection. This study is aimed to investigate whether there is drugresistant strains related detection difference between abbott realtime hbv realtime. Evolution of hbv markers in early infection this graph demonstrates the evolution of early hbv infection amongst panel members from the abbott realtime hbv m2000 and abbott architect hbsag test methods. Wirden m, larrouy l, mahjoub n, todesco e, damond f et al. The abbott realtime hcv reagents are intended to be used only on the abbott m2000 system consisting of the abbott m2000sp for sample processing and the.
Sequence conservation of the region targeted by the abbott. The index donations of these plasma donor seroconversion panels zeptometrix panels 6272 and 11,000 were positive for hbv dna and antihbs but negative for hbsag and antihbc. Abbott realtime hbv assay is more sensitive in detection. Distribution of abbott realtime hbv dna values with a. Who prequalification of diagnostics programme public. High levels of hepatitis b surface antigen increase risk. The aim of this prospective study was to evaluate the performance of the abbott realtime pcr assay for hbv dna quantitation by comparison with the standard versant hbv dna 3. Hepatitis b virus hbv, quantitative, dna abbott realtime. Abbott realtime hbv assay, abbott realtime hbv amplification reagent kit, abbott realtime hbv calibrator kit, abbott realtime hbv control kit. Who prequalification of diagnostics programme public report. Multilaboratory evaluation of realtime pcr tests for. In vitro polymerase chain reaction pcr based assay for hbv device trade name. The abbott realtime hbv test, developed for use on the abbott m2000tm automated instrument system, is designed for the quantitation precise measurement of hbv in human plasma or serum from patients known to be infected with the virus. The assays used in the initial screening were prism hbsag, prism hbcore, corzyme, axsym ausab, and abbott realtime hbv.
Seventy five microliters of whole blood was spotted on whatman 903 and hemaspot devices and air dried overnight at room temperature. Pdf prospective comparison of abbott realtime hbv dna and. This study aims to evaluate the performance of pocts for detection of hepatitis b virus surface antigen hbsag and antibodies to hepatitis c virus antihcv in chronic kidney. The performance of abbott realtime hbv quantification kit was excellent. The abbott realtime hcv assay is not for screening blood, plasma, serum or tissue donors for hcv, or to be used as a diagnostic test to confirm the presence of hcv infection. Serum hepatitis b surface antigen levels help predict. Application parameters specific to the abbott realtime sarscov2 assay are contained on an assayspecific application specification file. Sep 18, 2009 clinical performance of abbott realtime hepatitis c virus hcv genotype ii test the safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Comparison of abbott and daan realtime pcr for quantitating. Molecular and serological characterization of hepatitis b. Serum samples at enrollment and the third year of followup were tested for both hbv dna and hbsag levels. Prospective comparison of abbott realtime hbv dna and. Approved hiv, hav, hbv, hcv, and std diagnostic or monitoring assays by manufacturer and platform manufacturer platform hi vhav hb hc chlamydia,gonorrhea, syphilis abbott architect hiv agab combo anit. Hbv dna standards as well as a total of 180 clinical serum samples from patients with chronic hepatitis b were measured using the abbott and daan realtime polymerase chain reaction pcr assays. Fda approved hiv, hav, hbv, hcv, and std diagnostic or. 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. Comparison of the abbott alinity m and m2000 assays for the. A pcr test that offers consolidated hcv viral load and hcv genotype testing. Results the advansure hbv pcr showed good correlations with the three other hbv dna assays. In our recent published study 10 evaluatingthe correlations between two commercially available hbv viral load assays abbott realtime hbv assay, hereafter, realtime and.
The nvrl will replace its current hepatitis c and hepatitis b viral load assays roche diagnostics with the abbott realtime hcv and hbv assays in september 2012. The abbott realtime hbv assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and for. Prospective comparison of abbott realtime hbv dna and versant. Pdf abbott realtime hbv assay is more sensitive in. Selection of drugresistant strains may lead to failure of hbv antiviral therapy. Abbotts professional service experts and technology can help you achieve greater operational productivity leveraging informatics with existing resources. The new abbott realtime hepatitis b virus hbv assay was compared to the cobas ampliprepcobas taqman assay with 128 serum samples from patients with chronic hepatitis b. Aims point of care testing poct has been used for hepatitis b and c diagnosis in general population, but little is known about the influence of clinical conditions in the accuracy of these assays. The abbott realtime hbv is an in vitro polymerase chain reaction pcr assay for the quantitation of hepatitis b virus hbv dna in human plasma or serum from. Abbott realtime hbv assay is more sensitive in detection of low viral load and little impacted by drug resistant mutation in chronic hepatitis b patients under nucleotside analogues therapy.
Abbott realtime hbv assay, abbott realtime hbv amplification reagent kit, abbott realtime hbv calibrator kit, abbott realtime. Abbott realtime hbv assay is an in vitro polymerase chain reaction pcr assay for use with the abbott m2000 systemdna reagents and with the abbott. Pdf comparison of the advansure hbv realtime pcr test with. Evaluation of the abbott realtime hbv dna assay and.
The new abbott realtime hepatitis b virus hbv assay was compared to the cobas ampliprepcobas taqman assay with 128 serum samples. Fda for use by authorized laboratories, using realtime rt polymerase chain reaction pcr technology for the qualitative detection of nucleic acids from the sarscov2 virus and diagnosis of sarscov2 virus infection from individuals. Abbott core laboratory personalized laboratory solutions. The abbott realtime hbv assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and for use as. Abbott realtime hbv assay control kit the abbott realtime hbv controls are used to establish run validity of the abbott realtime hbv assay when used for the quantitation of hepatitis b virus hbv dna in human serum and plasma edta from hbv infected individuals. Distribution of abbott realtime hbv dna values with a viral load below a or above b the. Dna levels were determined with abbott realtime hbv. Hbv positive plasma was used to generate whole blood panels targeting 16 log iuml. Each educational module discusses critical topics in clinical chemistry and immunoassay to help grow expertise and enable labs to better serve their physicians and patients. Control n abbott realtime hbv high positive control.
Pdf prospective comparison of abbott realtime hbv dna. Abbott realtime hbv assay is an in vitro polymerase chain reaction pcr assay. Study design plasma specimens sent for viral load determination were prospectively tested on m2000 and alinity m systems, according to manufacturers instructions. We compared the analytical performance of a random access, fully automated hbv assaydxn veris molecular diagnostics system beckman coulter, brea, ca, usawith that of abbott realtime hbv assay abbott laboratories, des plaines, il, usa. Abbott realtime hiv1 calibrator a and calibrator b 10c or colder abbott realtime hiv1 negative and positive controls 10c or colder abbott realtime hiv1 amplification reagent pack and internal control vials 10c or colder when not in use abbott msample preparation systemrna 4 x 24 preps 1530c. Pdf the quantitation of human hepatitis b virus hbv in the serum of infected patients is recommended to characterize the course of chronic. Apr 05, 2020 the performance of abbott realtime hbv quantification kit was excellent. Although vaccines for hepatitis b virus hbv are highly effective, hbv infections in. The abbott m2000sp and roche ampliprep protocols were performed using automated extraction meth. Sequences from the hbv s gene comprising the abbott realtime assay target regions were obtained from two sources, evivar medicaleastmelbourne,australiaandabbottdiagnostics abbott park, il. Name abbott realtime hiv1 intended use the abbott realtime hiv1 assay is an in vitro reverse transcriptionpolymerase chain reaction rtpcr assay for the quantitation of human immunodeficiency.
Comparison between abbott realtime hbv assay and cobas taqman hbv assay measurements using the realtime assay, hbv dna was detected in 216 of 220 chb patients, with a sensitivity of 98. Performance of point of care assays for hepatitis b and c. Normal whole blood was obtained from promeddx norton, ma. Abbott realtime hbv amplification reagent kit abbott realtime hbv control kit abbott realtime hbv calibrator kit the abbott realtime hbv assay uses pcr to generate amplified product from the dna genome of hbv in clinical specimens.
Performance evaluation of the beckman coulter dxn veris. The lower and upper limits of hbv dna quantification are 15iuml and 9. Abbott realtime hbv the abbott realtime hbv is an in vitro polymerase chain reaction pcr assay for the quantitation of hepatitis b virus hbv dna in human plasma or serum from hbvinfected individuals. Evaluation of the abbott realtime hbv dna assay and comparison to the cobas ampliprepcobas taqman 48 assay in monitoring patients with chronic cases of hepatitis b. Clinical performance of abbott realtime hepatitis c virus. To compare the performance of the daan realtime hepatitis b virus hbv dna assay and abbott realtime hbv assay. 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. Of note, none of the 4 patients with undetectable hbv dna levels determined using the realtime assay had detectable levels on the taqman assay. Bp0600020, abbott realtime hiv1 amplification reagent. Performance evaluation of abbott realtime hbv quantification. Abbott realtime hbv the abbott realtime hbv is an in vitro polymerase chain reaction pcr assay for the quantitation of hepatitis b virus hbv dna in human plasma or serum from hbv infected individuals. The aim of this prospective study was to evaluate the performance of the abbott realtime pcr assay.
This study was intended to assess the clinical performance of abbott realtime hbv quantification kit abbott laboratories, usa. After manual application of the abbott optical adhesive cover, the plate is. The hiv1 probe has a fluorescent moiety that is covalently linked to the 5. Multicenter comparison of the new cobas 6800 system with cobas ampliprepcobas taqman and abbott realtime for the quantification of hiv, hbv and hcv viral load. A pcr test that quantitates hepatitis b virus hbv dna in human plasma or serum from hbvinfected individuals. The new aptima hbv quant realtime tma assay accurately. Comparison of the abbott alinity m and m2000 assays for. A pcr test that quantitates hepatitis b virus hbv dna in human plasma or serum from hbv infected individuals. Evaluation of the abbott realtime hbv dna assay and comparison to the cobas ampliprepcobas taqman 48 assay in monitoring patients with chronic.
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