The Syphilis Rapid Test (Whole Blood/Serum/Plasma) 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.
Cat. No: SYP-A01
Benefits
Fast:Instant results within 15 minutesConvenient: Room temperature storage (2-30℃) , valid for 24 months
Easy to Use: No equipment is required to process the specimens or read the results
Non-Invasive Sampling: Vaginal Discharge
One Piece Syphilis Test Strips 99% Syphilis Health Check Rapid Test
Storage: | 2℃-30℃ | Sample Type: | Blood |
---|---|---|---|
User: | Professional | Accuracy: | 99% |
Certificate: | CE ISO 13485 | OEM: | OEM Customized Packing Avaliable |
Formats: | 25T/box 1T/box | After-sales Service: | Available |
Key Words: | FSH One Step Menopause Test | For The Crowd: | Preliminary Screening Of Infected People |
High Light: | One Piece Syphilis Test Strips,99% Syphilis Health Check Rapid Test,Syphilis Test Strips 99% |
Infection Disease Syphilis Rapid Test with CE certificate Test Device
Product Name | Syphilis Rapid Test |
Formats | Strip(3mm)Device(4mm) |
Place of Origen | China |
Specimen | Urine |
Read Time | 15 minutes |
Shelf life | 2 years |
Package | 25 device/box or 50 strip/Box |
Storage | 2℃-30℃ |
For professional in vitro diagnostic use only.
Intended Use
The Syphilis Rapid Test (Whole Blood/Serum/Plasma) 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.
Clinical Sensitivity, Specificity and Accuracy
The Syphilis Rapid Test (Whole Blood/Serum/Plasma) has correctly identified specimens of a seroconversion panel and has been compared to a leading commercial TPHA Syphilis test using clinical specimens. The results show that the relative sensitivity of The Syphilis Rapid Test Device (Whole Blood/Serum/Plasma) is 99.5% and the relative specificity is 99.3%.
Syphilis Rapid Test vs. TPHA
Method | TPHA | Total Results | ||
Syphilis Rapid Test | Results | Positive | Negative | |
Positive | 394 | 4 | 398 | |
Negative | 2 | 540 | 542 | |
Total Results | 396 | 544 | 940 |
Relative sensitivity: 99.5% (98.2%-99.9%)*
Relative specificity: 99.3% (98.1%-99.8%)*
Accuracy: 99.4% (98.6%-99.8%)*
* 95% Confidence Intervals
Storage
1.Store at 4~30℃ in the sealed pouch up to the expiration date printed on the package. Do not freeze.
2.The test cassette/strip should be used within 1 hour after taking out from the sealed pouch.
3.Keep away from sunlight, moisture and heat.
4.The manufacturing date is printed on the outer box.