GASDirect

Group A Streptococcus Direct Test

Overview:
Group A Streptococcus (GAS), Streptococcus pyogenes, is the most common agent of bacterial sore throat. Left untreated, Group A strep can lead to serious complications including rheumatic fever and glomerulonephritis. At the same time, overprescription of antibiotics has come under intense scrutiny, attributable to an alarming increase in drug resistant bacteria. Group A Streptococcal pharyngitis is the only common form of acute pharyngitis for which antibiotic therapy is indicated. Nonspecific signs and symptoms make laboratory tests essential for accurate diagnosis and treatment. It has been estimated that over 20 million physician office visits (adults and children) are due to sore throat symptoms each year. Of these, only about 2 million are diagnosed with Group A strep.

Use:
The Gen-Probe GASDirect™ Test for Group A Streptococcus is a DNA probe assay which uses nucleic acid hybridization for the qualitative detection of Group A Streptococcal RNA directly from throat swabs with high sensitivity and specificity. This direct probe eliminates the time and difficulty of culturing Group A Streptococci. Further, the 2000 edition of the American Academy of Pediatrics Red Book recommends that all negative rapid antigen assays be backed up by culture or a test that is equivalent to culture. Gen-Probe's GASDirect Test can be used to back up the negative rapid antigen assays or as a stand alone test.

Features/Benefits:
  • Provides fast, accurate diagnosis – same day results vs. 2-3 days for culture
  • Higher sensitivity than rapid direct antigen tests
  • Accuracy equivalent to standard culture
  • A recent study documented that Gen-Probe's GASDirect test is comparable to culture with respect to cost and assay performance, yet with an improved turn around time of 24 hours vs. 72 hours compared to culture.1
  • Streamlines workflow with a simple 3-step procedure
    • Enables batch testing
    • Decreases technician time
  • Automation options available for higher-volume labs
  • Since the signs and symptoms of viral and bacterial infections are broadly similar, accurately diagnosing these upper respiratory tract illnesses allows physicians to properly treat their patients without contributing to the further development of antibiotic resistant bacteria.
References:
  1. Chapin, K.C., P. Blake, and C.D. Wilson. 2002. Performance characteristics and utilization of rapid antigen test, DNA probe, and culture for detection of group A streptococcus in an acute care clinic. J. Clin. Microbiol. 40:4207-4210.
  2. Heiter, B.J. and P.B. Bourbeau. 1993. Comparison of the Gen-Probe Group A Streptococcus Direct Test with culture and a rapid streptococcal antigen detection assay for diagnosis of Streptococcus pharyngitis. J. Clin. Microbiol. 31:2070-2073.
  3. Pokorski, S.J., E.A. Vetter, P.C. Wollan, F.R. Cockerill. 1994. Comparison of Gen-Probe Group A Streptococcus Direct Test with culture for diagnosing Streptococcal pharyngitis. J. Clin. Microbiol. 32:1440-1443.
  4. Steed, L.L., E.K. Korgenski, J.A. Daly. 1993. Rapid detection of Streptococcus pyogenes in pediatric patient specimens by DNA probe. J. Clin. Microbiol. 31:2996-3000.
GASDirect Test GASDirect Test
Description: DNA probe assay which uses nucleic acid hybridization for the qualitative detection of Group A Streptococcal rRNA as an aid in the diagnosis of Group A Streptococcal pharyngitis from throat swabs.

  PI / MSDS
100 Tests #103890
500 Tests #103890B



Gen-Probe® Detection Reagent Kit Gen-Probe Detection Reagent Kit
Description: Detection reagent used on LEADER luminometers for non-APTIMA Gen-Probe assays.

  PI / MSDS
1200 Tests #1791
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Gen-Probe Incorporated
10210 Genetic Center Drive
San Diego, CA 92121
USA

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