Immunoassay for the detection of group A streptococcal antigen
Status™ Strep A Test(Box of 30)
Immunoassay for the detection of group A streptococcal antigen
Status™ Strep A Test
CLIA Waived with results in 5-10 minutes, the Status™ Strep A Test (Strip) rapidly detects the group A streptococcal antigen directly from throat swab specimens.
General Details
-
-
- CLIA WAIVED
- Easy extraction for fast reaction times
- Sensitivity of 96.2% and specificity of 98.7%
- Results in 5-10 minutes
- External negative and positive controls included
-
Box components
-
-
-
Test Kit (30)
-
Extraction Reagent A
- Extraction Reagent B
- Positive and Negative Control
- Rayon Throat Swabs
-
-
Status™ Strep A Test
Manuals + Instructions
Intended Use
Direct Group A Streptococcus Antigen Test Strip is a rapid immunochromatographic assay for the qualitative detection of group A streptococcal antigen directly from throat swab specimens. The test is intended for use in the physician’s offices, hospitals, and clinical laboratories as an aid in the clinical diagnosis of group A streptococcal infection.
Clinical Details
-
-
- Status Strep A 18/48 Culture Results
- Sensitivity (127/132): 96.2%
- Specificity (368/373): 98.7%
- Overall Accuracy (495/505) 98.0%
- Status Strep A 18/48 Culture Results
-
Storage
Status Strep A test strip should be stored at 2-30°C (35-86°F) in its original sealed pouch, out of direct sunlight. Do not freeze. Kit contents are stable until the expiration date printed on the outer box.
CONTACT
Direct Connect
Phone
(310) 957-9891