Principle: Chromatographic Immunoassay
Specimen: Urine
Analyte: Group A ß-haemolytic streptococcus
Cut-Off: 104 CFU/mL
Approval: CE
Sensitivity: 91.8%
Specificity: 99%
Accuracy: 97.9%
Country of Origin: Italy

1. HOW DOES THE STREP A TEST WORK?
Group A ß-hemolytic Streptococcus could be involved in infections of the pharynx. For appropriate antibiotic treatment to be administered, the bacterium must be identified first. STREP A TEST can detect Streptococcus A antigens through the specific antibodies it contains.

2.WHEN CAN THE TEST BE USED?
STREP A TEST can be carried out if there are symptoms such as pain when swallowing, sore
throat, red and swollen tonsils (sometimes with white spots or pus), small red patches on the back of the palate (soft or hard), swollen lymph nodes, fever, headache, nausea or vomiting, especially in children.

3.CAN THE RESULT BE INCORRECT?
The result is correct if the instructions are followed carefully. However, the result may be incorrect if STREP A TEST is wet before performing the test or if the sample from the pharynx is not collected and prepared correctly (carefully follow the instructions for collecting the sample from the pharynx –fig.D). Incorrect results may also be obtained if the test is carried out after treatment with antibiotics or at the beginning of the infection (the concentration of bacteria is below the level of detection).

4.HOW DO I INTERPRET THE TEST IF THE COLOUR AND INTENSITY OF THE TEST AND CONTROL BANDS ARE DIFFERENT?
The colour and the intensity of the bands are not
important for the interpretation of the result. The bands must be full and homogeneous. The test is positive regardless of the intensity of the colour of the Test band, even if it is weak.

5.WHAT IS THE PURPOSE OF THE CONTROL BAND?
The appearance of this band means the test has worked correctly.

6.WHAT SHOULD I DO IF THE RESULT IS POSITIVE? If the result is positive, Streptococcus A has been detected in the sample from the pharynx and you must consult a physician. Please be aware the STREP A TEST cannot distinguish between live and dead bacteria. Patients who have recently recovered from Streptococcus A or similar infections may test positive because of inactive bacteria that are still present in the body.

7.WHAT SHOULD I DO IF THE RESULT IS NEGATIVE?
A negative result means that the symptoms were not caused by the Streptococcus A or that the sample did not contain a concentration of bacteria that was high enough to be detected by the test. If symptoms persist, seek medical advice.

8. IS THE RESULT RELIABLE IF READ AFTER 10 MINUTES?
No. The test must be read 5 minutes after the procedure is completed and no later than 10 minutes from this time.

9. HOW ACCURATE IS THE STREP A TEST?
The device specifically identifies Group A ß-hemolytic Streptococcus when its concentration in the extracted sample is equal to or higher than 10^4 (il 4 va come apice) CFU/mL (cut-off value).
In some cases, samples with concentrations below this value (down to 5 x 10^3 CFU/mL) can yield a positive result. The Test is very accurate. Assessment reports show an analytical specificity of 100% (CI 95%: 90% - 100%) and a sensitivity of 94.29% (CI 95%: 86.6% - 99.9%) with an overall concordance rate of 97.14% (CI 95%: 93.24 - 99.9%). Although this test is reliable, it may yield false positive and negative results.