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Gen-Probe.

10210 Genetic Center Dr.

San Diego, CA 92121

Ordering/Pricing/Product Information

Phone: (858)410-8000

Toll Free: (800) 523-5001

Website: www.GEN-PROBE.com

SEXUALLY TRANSMITTED DISEASES

APTIMA COMBO 2[R] ASSAY

Second-generation nucleic acid amplification test uses target capture for in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC).

* Sensitivity superior to culture for CT (1)

* Detects CT and GC in a single tube

APTIMA[R] CT ASSAY AND APTIMA[R] GC ASSAY

Individual assays targeting different regions of rRNA from APTIMA COMBO 2.

* Performance equivalent to APTIMA COMBO 2 Assay

* CDC guidelines recommend that positive NAAT results be retested using a test that targets a different region than the primary test

APTIMA[R] TRICHOMONAS VAGINALIS ASSAY

For detection of Trichomonas vaginalis.

* Trichomonas vaginalis is the most common non-viral STD

* The assay utilizes the same technology as the APTIMA COMBO 2[R] Assay and may use the same specimens as those used with APTIMA COMBO 2 Assay

APTIMA[R] COLLECTION DEVICES

All APTIMA Assays utilize the same superior technology and offer the widest range of specimen choices for CT and/or GC testing.

* Endocervical Swab

* Urethral Swab

* Urine Specimen

* Patient-Collected or Clinician-Collected Vaginal Swab

* Thin Prep Liquid Pap Specimen

APTIMA[R] General Purpose Reagents (GPR)

May be used to facilitate laboratory developed tests by CLIA-Certified high complexity or research laboratories and may be used for the qualitative detection of nucleic acid based analytes.

* Reagent configuration similar to APTIMA Assays.

* Compatibility with DTS[R] Systems.

RESPIRATORY INFECTIOUS DISEASES

PRODESSE[R] PROFLU[TM]+ ASSAY

An easy-to-use, real-time multiplex RT-PCR kit for detection and differentiation of Influenza A, Influenza B and RSV.

* Widely used molecular test for flu

* Results can be obtained in less than 4 hours

PRODESSE[R] PRO FAST[TM]+ ASSAY

An easy-to-use real-time multiplex RT-PCR kit for detection and differentiation of Influenza A Virus Subtypes: seasonal A/ HI, seasonal A/H3 and 2009 H1N1 Influenza Virus.

* Companion test for ProFlu+

* Results can be obtained in 2 hours from nucleic acids

PRODESSE[R] PRO hMPV[TM]+ ASSAY

An easy-to-use real-time RT-PCR kit for detection of human metapneumovirus (hMPV) from nasopharyngeal swab (NP) specimens obtained from individuals exhibiting signs and symptoms of acute respiratory infection.

* Results can be obtained in as little as 4 hours

* Compatible with automated nucleic-acid extraction technology, which minimizes hands-on time and expedites results

PRODESSE[R] PROPARAFLU[TM]+ ASSAY

An easy-to-use real-time multiplex RT-PCR kit for detection and differentiation of parainfluenza 1, parainfluenza 2 and parainfluenza 3.

* Offers an important tool for the diagnosis and differentiation of viral respiratory disease

* Compatible with automated nucleic-acid extraction technology, which minimizes hands-on time and expedites results

PRODESSE[R] PROADENO[TM]+ ASSAY

An easy-to-use real-time PCR kit for Human Adenovirus detection for respiratory indications.

* Results in as Utile as 3 hours

* Easy to use and implement in the lab

GASTROINTESTINAL INFECTIOUS DISEASES

PRODESSE[R] PROGASTRO[TM] Cd ASSAY

An easy-to-use real-time PCR kit that rapidly and accurately detects toxigenic strains of C/osfridium difficile using real-time PCR technology.

* Results obtained in just 3 hours

* Targets the Toxin B (fcdB) gene of toxigenic strains of c. diff.

VIRALS

APTIMA[R] HCV RNA QUALITATIVE ASSAY

An in vitro target amplification-based nucleic acid probe test that detects HCV RNA in human plasma and serum utilizing Transcription-Mediated Amplification (TMA). The assay is indicated for use with specimens from the following populations:

* Individuals with antibody evidence of HCV infection with evidence of liver disease.

* Individuals suspected to be actively infected with HCV with antibody evidence.

* Individuals at risk for HCV infection with antibodies to HCV

Detection of HCV RNA is evidence of active HCV infection.

APTIMA[R] HIV RNA QUALITATIVE ASSAY

An in vitro nucleic acid assay system for the detection of HIV-1 in human plasma. It is intended for use as an aid in the diagnosis of HIV-1 infection, including acute or primary infection. Presence of HIV-1 RNA in the plasma of patients without antibodies to HIV-1 is indicative of acute or primary HIV-1 infection.

The assay may also be used as an additional test, when it is reactive, to confirm HIV-1 infection in an individual whose specimen is repeatedly reactive for HIV-1 antibodies.

MYCOBACTERIA

AMPLIFIED MTD[R] (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST

Direct target-amplified nucleic acid probe test for the in vitro diagnostic detection of Mycobacterium tuberculosis complex rRNA.

* First FDA-approved direct test for helping to diagnose smear-positive and smear-negative specimens.

* Test results available in a day compared to weeks for culture.

ACCUPROBE[R] CULTURE IDENTIFICATION TESTS

Offer definitive identification of the most commonly isolated mycobacteria.

* Deliver definitive results from a single colony or from broth media in only 50 minutes.

* Identifies Mycobacterium avium, M. intracellulare, M. avium complex, M. gordonae, M. kansasii, and M. Tubercu/os/s complex

FUNGI AND BACTERIA

ACCUPROBE[R] CULTURE IDENTIFICATION TESTS

Offer definitive identification of the most commonly isolated fungi, bacteria and mycobacteria.

* Identifies Blastomyces dermatitidis, Coccidioides immitis, and Hisfop/asma capsulaium

* Identifies Streptococcus agalactiae (Group B strep), Neisseria gonorrhoeae, Staphylococcus aureus, Listeria monocytogenes, and Streptococcus pneumoniae

STREPTOCOCCUS

GASDirect[R] ASSAY FOR GROUP A STREPTOCOCCUS

Nucleic acid hybridization for the qualitative detection of group A streptococcal RNA directly from throat swabs. (2)

INSTRUMENTATION

TIGRIS[R] DTS[R] System

The only automated system that is truly automated for all phases of molecular diagnostics testing.

* Offers full automation for sample preparation, sample processing, and results analysis

* Provides true walk-away freedom that dramatically increases laboratory efficiency

* Reduces ergonomic injuries, human error, labor costs, lab space and time-to-results

* Eliminates swab expression, vortexing/ centrifugation, sample sorting and manual pipetting

* Features exclusive GEN-PROBE direct tube sampling (DTS) technology to eliminate sample cap removal

DTS[R] SYSTEMS

Streamlines sample processing by combining GEN-PROBE DTS technology with sample preparation, the target capture system, and the detection system.

* Exclusive penetrable cap minimizes contamination

* Ten-tube unit design reduces splash and enables all reactions to occur in a single tube

* Solutions for high-, medium-, and low-volume laboratories

DTS 800 Systems--800 results in 8 hours DTS 400 Systems--400 results in 8 hours

(1.) APTIMA COMBO 2* Assay for in vitro diagnostic use [package insert]. San Diego, CA: Gen-Probe Incorporated; 2005.

(2.) Group A Streptococcus Direct Test [package insert]. San Diego, CA: Gen-Probe Incorporated; 2004.
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Title Annotation:PRODUCT INFORMATION
Publication:Medical Laboratory Observer
Date:Aug 1, 2011
Words:1031
Previous Article:Focus Diagnostics.
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