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Strep A Rapid Test

Ref. 800060-20

Rapid test for the detection of group A ß-hemolytic Streptococcus in throat swab. For professional in-vitro diagnostic use only

Strep A Rapid Test

STREPTOCOCCUS A

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.

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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.

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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.

TECH SPECS

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.

Test format rapid immunochromatographic lateral-flow assay
Results reading time 5 minutes
Sample pharyngeal swab
Cut-off 10^4 CFU/mL
Specificity 100%
Sensitivity 94.3%
Accuracy 97.1%

CONTENT

  • 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
  • 1 workstation
  • instructions for use

USE PROCEDURE

  1. Obtain the pharyngeal sample by using the material provided;
  2. Put the swab into the plastic tube and add the two diluent solutions;
  3. Mix the solutions and let the swab into the tube for 2-5 minutes. Remove it and collect as much liquid as possible;
  4. Apply the dropper to the tube and add 1 drop into the sample well. Wait 5 minutes before reading the result.

RESULTS INTERPRETATION

Negative no Strep A antigens have been detected in the sample or their concentration is below the reference cut-off.
Positive the test has identified the presence of specific Strep A antigens within the sample.

BIBLIOGRAPHY

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.

F.A.Q.

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.


The color and intensity of the lines do not affect the interpretation of the result. The test has to be considered positive regardless of the color intensity of the test line (T).