INTRODUCTION TO SYPHILIS
Syphilis is an infection caused by bacteria. Most often, it spreads through sexual contact. The disease starts as a sore that's often painless and typically appears on the genitals, rectum or mouth. Syphilis spreads from person to person through direct contact with these sores.
INTENDED USE
Syphilis Antibody Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Treponema Pallidum (TP) in whole blood, serum or plasma to aid in the diagnosis of Syphilis.
SUMMAR
MATERIALS
Materials Provided
- Individually packed test devices
- Disposable pipettes
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Materials Required but Not provided
- Specimen collection container
- Centrifuge
- Micropipette
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TEST PROCEDURE
Allow the test device, specimen, buffer, and/or controls to reach room temperature (15-30°C) prior to testing.
1. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and level surface.
For Serum or Plasma Specimens:
Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 5 mL), and transfer the specimen to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 µL) and start the timer. See illustration below. Avoid trapping air bubbles in the specimen well (S).
For Whole Blood (Venipuncture/Fingerstick) Specimens:
To use a dropper: Hold the dropper vertically, draw the specimen 0.5-1 cm above the Fill Line, and transfer 1 drop of whole blood (approximately 10 µL) to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 µL) and start the timer. See illustration below.
To use a micropipette: Pipette and dispense 10 µL of whole blood to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 µL) and start the timer.
3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
PERFORMANCE CHARACTERIST
Clinical Sensitivity, Specificity and Accuracy
The Syphilis Antibody Rapid Test has correctly identified specimens of a performance panel and has been compared to a leading commercial TPPA Syphilis test using clinical specimens.
| Method |
TPPA |
Total Results |
| Syphilis Antibody Rapid Test |
Results |
Positive |
Negative |
| Positive |
101 |
8 |
109 |
| Negative |
3 |
94 |
97 |
| Total Result |
104 |
102 |
206 |
Relative Sensitivity: 97.12% (95%CI: 91.80%~99.40%)
Relative Specificity: 92.16% (95%CI: 85.13%~96.55%)
Accuracy: 94.66% (95%CI: 90.65%~97.30%)
COMPANY PROFILE
Hangzhou lmmuno Biotech Co., Ltd is the original organization in lmmuno Group, which has engaged in this industry for more than 10 years. The team of Hangzhou lmmuno Biotech has developed a series of proteins and rapid test kits for the in vitro diagnostic industry in early stage.In the past few years we focused on the human medical diagnostic field which mainly cover the following directions: rapid tests for vector-borne diseases(VBDs), rapid tests for sexually transmitted diseases (STDs), rapid tests for respiratory system diseases, rapid tests for digestive system diseases and rapid test for drug of abuse. For now, we are paying more attention to the diagnosis of neglected tropical diseases (NTDs). With strong R&D ability we are capable to develop and produce test kits for customers in a short time, and our product quality is ahead of similar products in the market.
Certifications
Audited Supplier 
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