Abbott

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Abbott RealTime mSystems

M2000 REALTIME SYSTEM

The m2000 RealTime System incorporates a unique combination of leading science and enabling solutions.
abbott_m2000
m2000sp

m2000sp

Automation system that creates efficiency from bar-coded laboratory tubes through patient results
m2000rt

m2000rt

Fully automates amplification and detection of DNA, RNA or TNA. Enables reporting results with ease and confidence.
m24sp

m24sp

Automates sample preparation for lower volumes. Completely automates sample purification steps.

The Abbott m2000 RealTime System integrates advanced

automation with precise and proven performance of one of the largest

infectious disease menus available on a single platform.

patient-journey-timeline

Insights throughout the infectious disease patient journey help enable

earlier diagnosis, appropriate therapy selection, personalized care, and infectious disease monitoring.

CMV

The Abbott RealTime CMV assay is an in vitro polymerase chain reaction (PCR) assay for the quantitation of cytomegalovirus (CMV) DNA in human plasma or whole blood.

          The assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of initiation of therapy and for use as an aid in monitoring viral response to antiviral treatment as measured by changes in plasma or whole blood DNA levels.

CT/NG

The Abbott RealTime CT/NG assay provides detection of Chlamydia trachomatis and Neisseria gonorrhoeae with proven clinical performance in sexually transmitted disease testing.

                The Abbott RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA for C. trachomatis and the genomic DNA of N. gonorrhoeae in female endocervical or vaginal swab specimens, male urethral swab specimens, or in male and female urine specimens.

High sensitivity and specificity for dual detection of C. trachomatis and N. gonorrhoeae – Accurate results by avoiding cross reactivity with other organisms including non-STD Chlamydia and Neisseria species

HBV

The Abbott RealTime HBV Viral Load Assay is for quantitation of Hepatitis B virus in chronically infected HBV individuals. The Abbott RealTime HBV assay delivers accurate quantitation of genotypes  A, B, C, D, E, F, G, H

HCV Genotype II

Abbott Molecular offers consolidated hepatitis testing of both HCV genotype and viral load on the fully automated Abbott m2000sp/rt platform.

          The Abbott Realtime Genotype II assay determines the genotypes of hepatitis C virus in plasma and serum of HCV-infected individuals. The Abbott RealTime HCV Genotype II provides

>97.59% accuracy in HCV GT detection

>95% GT 1a, 1b subtyping

CT

The Abbott RealTime CT assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA for C. trachomatis in female endocervical or vaginal swab specimens, male urethral swab specimens, or in male and female urine specimens.

          The assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of initiation of therapy and for use as an aid in monitoring viral response to antiviral treatment as measured by changes in plasma or whole blood DNA levels.

EBV

Accurate quantitation of the Epstein-Barr Virus (EBV) is critical to the monitoring of post-transplant lymphoproliferative disease (PTLD) in immunocompromised graft recipients. The Abbott RealTime EBV assay provides precise, reliable viral load results for supporting clinical management decisions.

          The Abbott RealTime EBV assay has a low limit of quantification (corresponding to high sensitivity), which is helpful in transplant patients.

HCV

For HCV management, especially given the high cost of therapies, excellent performance at clinical decision points is critical for providing reliable results (at 25 IU/ML) to assess SVR. The Abbott RealTime HCV assay delivers accurate quantification of GT 1-6.

HIV-1

The Abbott RealTime HIV-1 assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the quantitation of Human Immunodeficiency Virus type 1 (HIV-1) in whole blood spotted on cards as dried blood spots (DBS) (i.e. obtained via venipuncture or capillary blood) or human plasma from HIV-1 infected individuals

The Abbott RealTime HIV-1 assay provides : Enhanced precision: Provides strong performance measuring low-level viremia

Accurate monitoring : Confidence to reliably detect changes to patient’s response status

Unique assay design: Partially double stranded probe, highly conserved target region and specific temperature profile ensure reliable detection of all groups and subtypes

HIV-1 Qualitative

The Abbott RealTime HIV-1 Qualitative is an in vitro amplification assay for the qualitative detection of Human Immunodeficiency Virus Type 1 (HIV-1) nucleic acids from human plasma and dried blood spots (DBS).

MTB RIF/INH Resistance

The Abbott RealTime MTB RIF/INH Resistance assay provides qualitative resistance detection within a single assay for the two most important first-line M. tuberculosis (TB) drugs.

Two MTB Resistance Tests in One Assay

          The Abbott RealTime MTB RIF/INH Resistance assay provides : Identification of rifampicin (RIF) resistance and isoniazid (INH) resistance targeting rpoB, katG    and inhA upper stream promoter regions in one assay  Sample inactivation procedure minimizes risk of infection during specimen handling 

HPV

The Abbott RealTime High Risk (HR) HPV assay is a qualitative in vitro polymerase chain reaction (PCR) assay that utilizes homogeneous target amplification and detection technology for the detection of high risk human papillomavirus (HPV) DNA in cervical cells collected in liquid cytology media. The Abbott RealTime HR HPV assay is intended to detect 14 high risk HPV genotypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68 and to partially genotype 16, 18 from other 12 high risk genotypes.

Detection of single and mixed infections

Solutions for low, medium, and high throughput laboratories up to 96 tests per run

Automation with m2000 System family

          The Abbott RealTime High-Risk HPV assay is designed for the detection of high-risk HPV genotypes in cervical specimens from women with precancerous lesions of the cervix uteri (≥ CIN2) and cervical cancer to provide clinically meaningful results in cervical cancer screening.

MTB

The Abbott RealTime MTB assay is an in vitro polymerase chain reaction (PCR) assay for the qualitative detection of MTB complex DNA in smear positive or smear negative specimen of sputum or bronchial alveolar lavage and N-acetyl-L-cysteine (NALC)-prepared sediments prepared from sputum and broncial alveolar lavage collected from individuals suspected of having tuberculosis (TB).

CERVI-COLLECT SPECIMEN COLLECTION KIT

The Cervi-Collect Specimen Collection Kit contains a transport tube and cervical brush. The transport tube contains 2.5 mL of specimen transport buffer and is used to stabilize DNA until sample preparation.

The benefits in utilizing the Cervi-Collect Specimen Collection Kit include:

Consolidation of cervical brush and transport tube in one sealed pouch allowing for simplified collection of cervical specimens for HPV testing

Direct use on the Abbott m2000sp and m24sp, automated sample preparation systems, reducing the number of manual steps and minimizing sampling errors by using the primary tube

MULTI-COLLECT KIT

The Abbott multi-Collect Specimen Collection Kit is intended for the collection and transportation of male and female, swab and urine specimens for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae per instructions provided.

HBV Sequencing Assay

The Abbott HBV Sequencing assay detects both HBV genotype and drug resistance in one test.

The Abbott HBV Sequencing assay targets the polymerase (pol) region of the HBV viral genome.

Variable low and high throughput automation options include:

Sample preparation with the m2000sp or m24sp

PCR m2000rt or Perkin Elmer 9700 Thermal Cycler or equivalent

Sequencing (Applied Biosystems 4 and 16 capillary systems. ABI SeqScape Software version 2.5 or later) Online reporting

ViroSeq HIV-1 Genotyping System v2.0

The ViroSeq HIV-1 Genotyping System is intended for use in detecting HIV genomic mutations that confer resistance to specific types of antiretroviral drugs, as an aid in monitoring and treating HIV infection.

The ViroSeq HIV-1 Genotyping System can be used to:

Detect HIV-1 Subtype B viral resistance in plasma samples collected in EDTA with a viral load ranging from 2000 to 750,000 copies/mL

Genotype the entire HIV-1 protease gene from codons 1-99 and two-thirds of the reverse transcriptase (RT) gene from codons 1-335

Indication for Use

The indications for use encompass the following populations:

HIV-1 infected individuals at drug therapy failure (with increased viral load) before therapy switch

HIV-1 infected individuals at initial presentation, before initial drug therapy

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