1. Introducció
The One Step Rapid Helicobacter Pylori Stool Antigen Test is an in-vitro diagnostic device designed for the qualitative detection of Helicobacter pylori antigens in human stool samples. This test is intended for professional and self-testing use as an aid in the diagnosis of H. pylori infecció.
Figure 1: Complete One Step Rapid H. Pylori Test Kit.
2. Informació de seguretat
- For in-vitro diagnostic use only. Do not ingest any components of the kit.
- Do not use the test beyond the expiration date printed on the foil pouch.
- No utilitzeu la prova si la bossa d'alumini està danyada.
- Handle all specimens as potentially infectious. Follow standard laboratory procedures for handling and disposal of infectious materials.
- Wear protective gloves when handling samples.
- Mantenir fora de l'abast dels nens.
- Consult a healthcare professional for diagnosis and treatment. This test provides preliminary results only.
3. Contingut del paquet
Cada kit conté els components següents:
- Test Cassette (individually foil-wrapped)
- Extraction Buffer Tube with Sample Collection Stick
- Manual d'instruccions
Figure 2: Extraction Buffer Tube and Sample Collection Stick.
4. Configuració i preparació
- Allow the test cassette and extraction buffer to reach room temperature (15-30°C or 59-86°F) prior to testing.
- Ensure you have a timer readily available.
- Wash your hands thoroughly before and after handling the sample.
5. Instruccions de funcionament
Follow these steps carefully to perform the test:
- Sampla col·lecció: Collect a fresh stool sample. Unscrew the cap of the extraction buffer tube, which has an integrated sample collection stick. Collect stool sample de three different sites of the stool by inserting the stick into the sample. Do not scoop a large amount; just ensure the grooves on the stick are covered.
- Sample Mixing: Insereix el sample collection stick back into the extraction buffer tube. Screw the cap tightly. Shake the tube vigorously for 2 minuts to ensure the stool sample is thoroughly mixed with the extraction buffer.
- Preparació per a la dispensació: Break off the tip of the extraction buffer tube at the designated point. This will create a dropper.
- Aplicar SampLI: Open the foil pouch and place the test cassette on a clean, flat surface. Dispense exactly 2 full drops of the extracted sample al sampel pou (S) del casset de prova.
- Wait for Results: Start the timer immediately. Read the results after exactly 10 minuts. Do not read the results after 15 minutes, as this may lead to inaccurate readings.
Figure 3: Step-by-step operating instructions for the H. Pylori test.
6. Interpretació de resultats
The intensity of the line color has no bearing on the interpretation of the test result. Read results after exactly 10 minutes. Do not read after 15 minutes.
Resultat positiu:
Two colored lines appear, one in the test section (T) and one in the control section (C). This means the test has detected the presence of H. Pylori, and you should consult your doctor for further evaluation and treatment.
Resultat negatiu:
Only one colored line appears in the control section (C). This means no presence of H. Pylori has been detected in the sample.
Resultat no vàlid:
No line appears after the reading time, or a colored line appears only in the test region (T). For the result to be valid, the line must always appear in the control region (C). If you obtain an invalid result, you must repeat the test using a new kit.
7. Solució De Problemes
| Problema | Causa possible | Solució |
|---|---|---|
| No control line (C) appears. | Insuficient sample volume, incorrect procedure, or expired/damaged test kit. | Ensure 2 full drops of sample are added. Review operating instructions carefully. Repeat the test with a new kit. |
| Only the test line (T) appears. | Invalid test. The control line (C) must always appear for a valid result. | Repeat the test with a new kit, ensuring proper procedure. |
| Results are unclear or faint. | Reading the test too early or too late. | Ensure results are read exactly at the 10-minute mark. Do not interpret results after 15 minutes. |
8. Especificacions
- Fabricant: Un pas
- Referència del model: ONSTPSTM
- Dimensions del paquet: 14 x 9.3 x 2.4 cm; 30 g
- ASIN: B07DRHN24P
- Specific Product Uses: Gastritis
- Primera data disponible: 24 de maig de 2019
9. Garantia i Suport
For any questions regarding the product, its performance, or to report an issue, please contact the manufacturer, One Step, or your point of purchase. Please refer to the product's packaging for specific contact details or visit the official One Step weblloc web per obtenir informació de suport.
This product is intended for diagnostic aid and does not replace professional medical advice. Always consult with a healthcare provider for diagnosis and treatment.
