Strep A Test

Ref. 800060-1

Self-test for the detection of group A ß-hemolytic Streptococcus in pharyngeal infections

STREPTOCOCCUS A

Group A ß-haemolytic streptococcus (also known as Streptococcus pyogenes) is a gram positive bacterium that causes a variety of pathological conditions and complications such as throat and skin infections, acute glomerulonephritis, sepsis and rheumatic heart disease.

Pharyngitis is commonly caused by viral infections and, more rarely, by bacterial infections, for which antibiotic therapy is required.

WHO IS THIS TEST FOR?

STREP A TEST is aimed at anyone who wants to monitor 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.

TECH SPECS

STREP A TEST is an immunochromatographic device that detects the presence of specific Strep A antigens in pharyngeal samples.

Specificity	99.0%
Sensitivity	91.89%
Accuracy	97.9%

CONTENT

1 test cassette
1 vial with dropper containing the R1 solution
1 vial with dropper containing the R2 solution
1 sterile swab
1 sterile tongue depressor
1 empty plastic tube with dropper
instructions for use

USE PROCEDURE

Collect the pharyngeal sample by using the provided material;
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.

RESULTS INTERPRETATION

Negative	no Strep A antigens have been detected in the sample or their concentration is below the reference cut-off.
Positive	Strep A antigens have been detected in the sample. It is recommended to contact your doctor who will recommend you the right therapy.

VIDEO INSTRUCTIONS

BIBLIOGRAPHY

1. 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.
2. 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 2016.
3. 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.

F.A.Q.

What happens if the results reading time is not met? 

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. 

How to prove that the test worked correctly? 

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. 

How to interpret the test if the control and test lines have different intensities? 

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). 