CYSTI'TEST® - User manual

Oct 12, 2026

CYSTI'TEST® is a professional rapid urine test designed for qualitative detection of leukocytes and nitrites to support diagnosis of urinary tract infections. The test uses reagent squares on urine strips and a color chart to interpret results after a 2-minute reaction time. It explains test principles, reagent composition, provided equipment, storage conditions, stability requirements, warnings, sample collection limits, and a step-by-step procedure.

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INDICATION FOR USE

INTRODUCTION

PRINCIPLE OF THE TEST

EQUIPMENT PROVIDED

MATERIALS REQUIRED BUT NOT PROVIDED

STORAGE AND STABILITY

WARNINGS AND PRECAUTIONS

SAMPLE COLLECTION AND PREPARATION

PROCEDURE

INTERPRETATION OF THE RESULTS

CYSTI'TEST® Rapid hygienic test for the detection of nitrites and leukocytes in urine Ref.: TR-URI-002 User manual INDICATION FOR USE CYSTI'TEST® is a rapid test for the qualitative detection of 2 parameters (leukocytes, nitrites) in urine samples. CYSTI'TEST® is a rapid test for professional use that helps in the diagnosis of urinary tract infections. INTRODUCTION Urinary tract infections are quite common situations, affecting both adults and children. Some are benign, such as simple acute cystitis in women; Others have a potentially serious course with a risk of kidney infection (pyelonephritis) on a stone (lithiasis) that requires an emergency consultation. CYSTI'TEST® allows a rapid examination to be carried out that can guide the diagnosis of simple acute urinary tract infection in the absence of risk factors (pregnancy, severe kidney failure, immunosuppression, age > 65 years) . CYSTI'TEST® allows urine to be tested for nitrites and leukocytes in a single examination. PRINCIPLE OF THE TEST CYSTI'TEST® is a rapid hygienic test carried out using a urine strip to which reagent squares are attached, capable of changing colour in the presence of certain substances. The urine strips are interpreted using the colour chart printed on the jar containing the urine strips. The reading is done after a reaction time of 2 minutes. By comparing the colour of each square to this colour chart, it is possible to interpret the presence or absence of certain elements. | Parameter | Principle | Composition | | --- | --- | --- | | Nitrite | The test depends on the diazotation of nitrite with aromatic amino sulfonamide to form a diazonium compound. This diazonium compound in turn couples with 1,2,3,4-tetrahydro-benzo(h)quinolin-3-phenol to produce a pink color. | 1.3% w/w of 1,2,3,4-tetrahydro-benzo(h)quinolin-3-phenol;
89.6% w/w buffer;
9. 1% w/w non-reactive ingredients | | Leukocyte | Granulocyte leukocytes in the urine contain esterases that catalyze the hydrolysis of the amino acid ester pyrrole to release 3-hydroxy-5-phenyl pyrrole. This pyrrole then reacts with a diazonium salt to form a purple color. | 4.3% w/w pyrrole-derived amino acid ester; 0.4% w/w of diazonium salt;
92.6% w/w buffer;
2.7% w/w non-reactive ingredients | EQUIPMENT PROVIDED - 1 jar of 25 urine strips with color chart - 25 hygienic bottles for urine collection and urine dipstick interpretation - 25 zip plastic bags - 1 user manual including a simplified operating procedure MATERIALS REQUIRED BUT NOT PROVIDED - Timer STORAGE AND STABILITY The kit can be stored at room temperature between 2 and 30°C. Do not store it in the refrigerator, do not freeze it. Keep away from direct sunlight. Store the strips in their original jar. Do not remove the desiccant bag(s) . REMOVE THE STRIP FROM THE JAR ONLY IMMEDIATELY BEFORE USING IT FOR THE TEST. Replace the cap immediately on the jar and screw it on firmly after removing the strip. After opening the jar, the urine strips should be used within 18 months without exceeding the expiry date indicated on the jar. WARNINGS AND PRECAUTIONS • For professional in vitro diagnostic use only. • Urine strips should remain in their tightly sealed jar until they are used. • Do not use the kit after the expiration date. • Urine strips and urine collection bottles are for single use. • Do not touch the reactive squares of the urine strips with your fingers. • Wear appropriate protective clothing, gloves, and eye/face protection when handling the contents of this kit. The equipment used must be disposed of in accordance with local regulations. SAMPLE COLLECTION AND PREPARATION • Collect fresh urine in the bottle provided and place it in the zipped plastic bag provided in the kit. The amount should be between the"Min" and "Max" markings on the vial label. Remove excess urine if the fill level exceeds the "Max" line. • The sample must not have been collected more than 2

FAQs

What does CYSTI'TEST® detect in urine samples?

It detects two parameters qualitatively: leukocytes and nitrites in urine. Results are used to help guide diagnosis of urinary tract infections.

How long does the test take before reading results?

Read the test result after a reaction time of 2 minutes.

What are the key storage and stability requirements for the kit?

Store at room temperature between 2 and 30°C, avoid refrigeration and freezing, keep away from direct sunlight, and keep strips in their original jar without removing the desiccant.

Oct 12, 2026

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