DIATHER Test Streptococcus A Throat

TEST FOR STREP A THROAT to detect the presence of Streptococcus group A antigen in a throat swab sample.  Results within 5 minutes. The test helps determine the cause of sore throat. Whether the pain is caused by Streptococcus group A bacteria (also known as Streptococcus pyogenes), which requires antibiotic treatment, or by a viral infection that does not require antibiotics.

INDICATIONS FOR TESTING

red throat (especially if accompanied by a white coating)

sore throat

fever

vomiting (especially in children)

difficulty swallowing saliva and food

headache

PRODUCT CHARACTERISTICS

Streptococcal sore throat is a serious disease that can cause lifelong complications (e.g., glomerulonephritis, peritonsillar abscess). Rapid antibiotic therapy can protect you and your child from complications and hospitalisation. Our test accelerates the diagnostic process and treatment for you and your child. Streptococcus pyogenes, the bacteria causing sore throat, is a pathogenic bacteria characterised by the presence of group A antigens. It can cause serious infections such as severe bacterial pharyngitis, impetigo, endocarditis, meningitis, postpartum sepsis, and arthritis. Untreated infections may lead to serious complications like rheumatic fever and peritonsillar abscess.

HOW TO PERFORM THE TEST?

Step 1: Preparation of the solution: add 4 drops of reagent 1 to the test tube, then 4 drops of reagent 2. Gently mix the solution.

Step 2: Sample collection: collect a sample from the throat using the swab included in the kit. It is recommended to take the swab from the posterior wall of the throat, tonsils, and other inflamed areas. Place the swab with the sample into the test tube with the solution. Rotate the swab in the test tube, then leave the swab in the tube for about 1 minute to extract the antigens from the swab.

Step 3: Material extraction: gently press the tip of the swab against the wall of the test tube to squeeze out as much material as possible. Remove the swab from the tube, squeezing it with the walls of the tube.

Step 4: Preparing the test cassette: place the pipette tip on top of the test tube. Remove the cassette from the pouch and place it on a flat, clean surface. Add 3 drops of the solution into the well of the test cassette (S). Start the timer. Results should be read within 5 minutes.

PACKAGE CONTENTS

1 cassette test pouch

1 reagent “1”

1 reagent “2”

1 extraction tube

1 dropper tip

1 sterile swab

1 ENT spatula

Instructions for use

WARNINGS AND PRECAUTIONS

Read the instructions carefully before performing the test. The test result is reliable only if all instructions are followed.

Keep the test out of reach of children.

Do not use the test after the expiry date or if the packaging is damaged.

Follow the procedure regarding reaction time and sample preparation.

Store test components at +2°C to +30°C; do not freeze.

The sterile swab is for single use only.

For external use only.

In vitro diagnostic test for self-testing.

Not intended for children under 2 years of age.

Dispose of all elements according to local regulations after use.

If deciding to proceed without medical consultation, consult a healthcare professional.

If the sample contacts skin or gets into eyes or other mucous membranes, rinse immediately with plenty of water and seek medical advice.

Do not swallow any part of the packaging.

STORAGE

Store the product in the unopened pouch at room temperature or between 2-30°C. The test is valid until the expiry date printed on the pouch. Store in a closed container before use. DO NOT FREEZE. Do not use after the expiry date.

This is a medical device. Use it according to the instructions for use or the label.

Manufacturer: Microtrace Diagnostici Srl. Italy, Via IV Novembre, 84, Novafeltria (RN) 47863

Responsible entity: Diather Petrusewicz Sp. K. Ku Ujściu 19 80-701 Gdańsk

Advertising entity: Bionic sp. z o.o., al. Grunwaldzka 415, 80-309 Gdańsk