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Infectious Diseases

Strep A Detection Strip - CLIA Waived

STR-15SGPU-25
25 Tests/Kit
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Product Code: STR-15SGPU-25
Sample: Throat Swab
Format: Strip
Quantity: 25 Tests/Kit
Sensitivity: 96.5%
Specificity: 99.5%
Time to result: 5 minutes
Storage Condition: 36-86°F/2-30°C
Test Principle: Lateral Flow Immunoassay
Contents
  • 25 Test Strips
  • 25 Sterile Swabs
  • 25 Disposable extraction tubes (One tube for each test strip)
  • 1 Reagent A (10mL; 2M Sodium Nitrite)
  • 1 Reagent B (10mL; 0.2M Acetic Acid)
  • 1 Positive Control (1mL: Non-viable Strep A; 0.05% ProClin™ 300)
  • 1 Negative Control (1mL: Non-viable Strep C; 0.05% ProClin™ 300)
  • 2 Tube Holders
  • 1 Instructions for Use
  • 1 Quick Regerence Instructions
Description

The Rapid Response™ Strep A Detection Strip is a rapid test for the qualitative detection of Streptococcus pyogenes (Group A ß-hemolytic Streptococcus, Strep A) antigen from throat swab specimens of symptomatic patients to aid in the diagnosis of Group A Streptococcus bacterial infection, providing results within 5 minutes.

References
  1. Webb, KH. Does Culture Confirmation of High-sensitivity Rapid Streptococcal Tests Make Sense? A Medic Decision Analysis. Pediatrics (Feb 1998), 101:2, 2.
  2. Bisno AL, Gerber MA, Gwaltney JM, Kaplan EL, Schwartz RH. Diagnosis and Management of Group A Streptococcal Pharyngitis. Clinical Infectious Diseases (1997), 25: 574-83.
  3. Needham CA, McPherson KA, Webb KH. Streptococcal Pharyngitis: Impact of a High-sensitivity Antigen Test on Physician Outcome. Journal of Clinical Microbiology (Dec 1998), 36: 3468-3473.
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