Rapid test for the detection of group A ß-hemolytic Streptococcus in throat swab. For professional in-vitro diagnostic use only
Group A ß-haemolytic streptococcal infection in the throat (also known as Streptococcus pyogenes) is the most common bacterial cause of acute pharyngitis and is also responsible for some skin infections such as impetigo and erysipelas.
Most types of sore throat are instead caused by viral infections, which heal without the need for antibiotic treatments, which would therefore be useless. Strep A infections can subside within days without treatment, although doctors typically prefer to prescribe antibiotics to prevent infection-related complications that can be serious, such as rheumatic fever or acute glomerulonephritis.
Benefit of the test
Easy to use
Results in 5 minutes
Rapid support for healthcare personnel, including pediatric personnel
WHO IS THIS TEST FOR?
STREP A RAPID TEST is an immunochromatographic test aimed at monitoring the possible bacterial origin of a pharyngitis.
Understanding whether a sore throat is caused by the Strep A bacterium or other germs allows you to identify, or rule out, a possible antibiotic treatment.
STREP A RAPID TEST is a rapid immunochromatographic test for the qualitative lateral flow determination of Strep A antigen in a throat swab. In this test, the specific anti-Strep A antigen antibody is adhered to the test area. During testing, the throat swab specimen reacts with anti-Strep A antibody attached to colloidal gold particles.
rapid immunochromatographic lateral-flow assay
Results reading time
20 test cassettes
20 vials with dropper containing the R1 solution
20 vials with dropper containing the R2 solution
20 sterile swabs
20 sterile tongue depressors
20 empty plastic tubes with dropper
instructions for use
Obtain the pharyngeal sample by using the material provided;
Put the swab into the plastic tube and add the two diluent solutions;
Mix the solutions and let the swab into the tube for 2-5 minutes. Remove it and collect as much liquid as possible;
Apply the dropper to the tube and add 1 drop into the sample well. Wait 5 minutes before reading the result.
no Strep A antigens have been detected in the sample or their concentration is below the reference cut-off.
the test has identified the presence of specific Strep A antigens within the sample.
1. Banerjee S, Ford C. “Rapid Tests for the Diagnosis of Group A Streptococcal Infection: A Review of Diagnostic
2. Test Accuracy, Clinical Utility, Safety, and Cost-Effectiveness “. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2018 May. CADTH Rapid Response Reports
3. Centers for Disease Control and Prevention. Adult appropriate antibiotic use summary. http://www.cdc.gov/getsmart/community/materials-references/print-materials/hcp/adult-approp-summary.pdf. Accessed March 8, 2016
4. Llor C., Bjerrum L., Munck A., Cots JM., Hern ndez S., Moragas A.; HAPPY AUDIT Investigators. “Access to point-of-care tests reduces the prescription of antibiotics among antibiotic-requesting subjects with respiratory tract infections.” Respir Care. 2014 Dec.
The test has been carried out correctly when the instructions for use are followed. It includes the reading time and the interpretation of the results shown at the "RESULTS INTERPRETATION" section of the instructions for use.
A colored line will appear at the control region (C) on the test device, showing that the test performed correctly. The absence of the colored line suggests to repeat the test with a new device and a new sample.
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