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Strep A Rapid Test

Ref. 800060IP-20P

Rapid immunochromatographic test for the detection of group A ß-hemolytic Streptococcus in throat swab. IVD for professional use only.

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. It is a diagnostic device particularly useful in fragile subjects and, therefore, indicated for elderly and pediatric patients.

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.

Cut-off 10^4 CFU/mL
Specificity 100%
Sensitivity 94.3%
Accuracy 97.1%

CONTENT

  • 20 test cassettes
  • 1 R1 solution
  • 1 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. Anjos LM, Marcondes MB, Lima MF, Mondelli AL, Okoshi MP, Streptococcal acute pharyngitis, Rev Soc Bras Med Trop 2014; 47(4):409-13;
2. Castro SA, Dorfmueller HC A brief review on Group A Streptococcus pathogenesis and vaccine development, R Soc Open Sci 2021;
3. Banerjee S, Ford C. “Rapid Tests for the Diagnosis of Group A Streptococcal Infection: A Review of Diagnostic Test Accuracy, Clinical Utility, Safety, and Cost-Effectiveness “. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2018 May. CADTH Rapid Response Reports;
4. Llor C, Bjerrum L, Munck A, Cots JM, Hernández 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;
5. Georgers N. Nakhoul, MD and John Hickner, MD, MSc, Management of Adults with Acute Streptococcal Pharyngitis: Minimal Value for Backup Strep Testing and Overuse of Antibiotics, J Gen Inter Med. 2013 Jun, 28(6):830-834;
6. Emily H. Stewart, Brian Davis, B. Lee Clemans-Taylor, Benjamin Littenberg, Carlos A. Estrada, and Robert M. Centor, Rapid Antigen Group A Streptococcus Test to Diagnose Pharyngitis: A Systematic Review and Meta-Analysis, PLoS One. 2014; 9(11);
7. Parks T, Barrett L, Jones N. Invasive streptococcal disease: a review for clinicians. British Medical Bulletin, Volume 115, Issue 1, September 2015, Pages 77–89.

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).


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