Abbott

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 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).

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

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

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

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.

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.

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

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.

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

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.