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Strep A Molecular Test
Test CodeLAB885
Alias/See Also
RSTAM, Rapid Strep A, RST, Group A Rapid Beta Strep Screen
CPT Codes
87651
Includes
Per CDC recommendations, all specimen with negative results from patients 18 years of age and under will be cultured. Culture is recommended in adults if clinical symptoms are inconsistent with results. (Cultures on adults will need to be specifically requested by the ordering provider).
Preferred Specimen
Use ESwab™ Collection Kit, Liquid Amies collection swab
Instructions
Collect patient specimen by swabbing the posterior pharynx, tonsils and other inflamed areas. Avoid touching the tongue, cheeks and teeth with the swab. Specimen must be labeled with patient's first and last name, birth date, source and date/time collected.
Specimen Stability
Room temperature (20'C) 24 hours
Refrigerated (2-8'C) 24 hours
Refrigerated (2-8'C) 24 hours
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Failure to follow collection instructions.
Methodology
Alere™ i Strep A utilizes isothermal nucleic acid amplification technology for the qualitative detection of Group A Strep bacterial nucleic acids.
Setup Schedule
Daily
Report Available
Within 2 days.
Limitations
• Alere™ i Strep A does not distinguish between viable and nonviable organisms.
• Performance of Alere™ i Strep A has not been established for monitoring treatment of pharyngitis caused by Group A Strep.
• Alere™ i Strep A will not differentiate asymptomatic carriers of Group A Strep from those exhibiting streptococcal infection.
• False-negative results may occur in the presence of assay inhibitors when levels of S. pyogenes DNA are close to the limit of detection of the assay.
• False-negative results may occur if a Sample Receiver for an assay other than Alere™ i Strep A is used.
• Performance of Alere™ i Strep A has not been established for monitoring treatment of pharyngitis caused by Group A Strep.
• Alere™ i Strep A will not differentiate asymptomatic carriers of Group A Strep from those exhibiting streptococcal infection.
• False-negative results may occur in the presence of assay inhibitors when levels of S. pyogenes DNA are close to the limit of detection of the assay.
• False-negative results may occur if a Sample Receiver for an assay other than Alere™ i Strep A is used.
Reference Range
The sensitivity of the test is reported to be better than 95%. A negative result indicates either the absence of Group A strep or nucleic acids below the detection level of the assay.
