The Rapid Response Strep A Test Strip is a rapid, qualitative test for the detection of strep A antigen from throat swab specimens, to aid in the diagnosis of group A streptococcal infection.
It is an efficient, accurate, and reliable method of testing that can be used by any healthcare professional. It is easy to use and delivers results within 5 minutes!
It is intended for in vitro diagnostic use only.
Interpretation of test results are: positive (two lines), negative (one line), invalid (no lines or no Control line).
Box Contents
- 25 Test Strips
- 25 Extraction Test Tubes
- 25 Sterile Swabs
- 1 Workstation
- 1 Strep A Reagents A
- 1 Strep A Reagents B
- 1 Positive Control
- 1 Negative Control
- 1 Procedure Card
- 1 Package Insert
Intended Use
The Rapid Response™ Strep A Test Strip is a rapid, qualitative test for the detection of strep A antigen from throat swab specimens, to aid in the diagnosis of group A streptococcal infection. This test is authorized for use at the Point of Care i.e., in patient care settings.
Results are for the identification of group A streptococcus antigen. Antigens are generally detectable in throat secretions. Positive results indicate the presence of bacterial antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.
Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories are required to report all positive results to the appropriate public health authorities.
Negative results should be treated as presumptive, and do not rule out Group A Streptococcus infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with Group A Streptococcus, and confirmed with a molecular assay, if necessary, for patient management.
The Rapid Response™ Strep A Test Strip Device is intended for use by trained laboratory personnel or health care professionals.
By purchasing this product, you agree to follow the manufacturer’s intended use and the sale conditions of this website.
