One Step Rapid Helicobacter Pylori Stool Antigen Test

1. Introduction

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 infection.

Figure 1: Complete One Step Rapid H. Pylori Test Kit.

2. Safety Information

• 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.
• Do not use the test if the foil pouch is damaged.
• Handle all specimens as potentially infectious. Follow standard laboratory procedures for handling and disposal of infectious materials.
• Wear protective gloves when handling samples.
• Keep out of reach of children.
• Consult a healthcare professional for diagnosis and treatment. This test provides preliminary results only.

3. Package Contents

Each kit contains the following components:

• Test Cassette (individually foil-wrapped)
• Extraction Buffer Tube with Sample Collection Stick
• Instruction Manual

Figure 2: Extraction Buffer Tube and Sample Collection Stick.

4. Setup and Preparation

1. Allow the test cassette and extraction buffer to reach room temperature (15-30°C or 59-86°F) prior to testing.
2. Ensure you have a timer readily available.
3. Wash your hands thoroughly before and after handling the sample.

5. Operating Instructions

Follow these steps carefully to perform the test:

1. Sample Collection: Collect a fresh stool sample. Unscrew the cap of the extraction buffer tube, which has an integrated sample collection stick. Collect stool sample from 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.
2. Sample Mixing: Insert the sample collection stick back into the extraction buffer tube. Screw the cap tightly. Shake the tube vigorously for 2 minutes to ensure the stool sample is thoroughly mixed with the extraction buffer.
3. Prepare for Dispensing: Break off the tip of the extraction buffer tube at the designated point. This will create a dropper.
4. Apply Sample: Open the foil pouch and place the test cassette on a clean, flat surface. Dispense exactly 2 full drops of the extracted sample into the sample well (S) of the test cassette.
5. Wait for Results: Start the timer immediately. Read the results after exactly 10 minutes. 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. Interpreting Results

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.

• Positive Result:

  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.

• Negative Result:

  Only one colored line appears in the control section (C). This means no presence of H. Pylori has been detected in the sample.

• Invalid Result:

  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. Troubleshooting

8. Specifications

• Manufacturer: One Step
• Model Reference: ONSTPSTM
• Package Dimensions: 14 x 9.3 x 2.4 cm; 30 g
• ASIN: B07DRHN24P
• Specific Product Uses: Gastritis
• First Available Date: May 24, 2019

9. Warranty and Support

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 website for support information.

This product is intended for diagnostic aid and does not replace professional medical advice. Always consult with a healthcare provider for diagnosis and treatment.