Hangzhou Aichek Medical Technology Co.,Ltd
| Payment Terms | T/T |
| Supply Ability | negotiable |
| Packaging Details | 40box/carton |
| 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 |
| Brand Name | Aichek |
| Model Number | SYP-A01 |
| Certification | CE |
| Place of Origin | China |
View Detail Information
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Product Specification
| Payment Terms | T/T | Supply Ability | negotiable |
| Packaging Details | 40box/carton | 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 | Brand Name | Aichek |
| Model Number | SYP-A01 | Certification | CE |
| Place of Origin | China | ||
| High Light | One Piece Syphilis Test Strips ，99% Syphilis Health Check Rapid Test ，Syphilis Test Strips 99% | ||
| 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
SUMMARY
Treponema Pallidum (TP) is the causative agent of the venereal disease Syphilis. TP is a spirochete bacterium with an outer envelope and a cytoplasmic membrane.1 Relatively little is known about the organism in comparison with other bacterial pathogens. According to the Center for Disease Control (CDC), the number of cases of Syphilis infection has markedly increased since 1985.2 Some key factors that have contributed to this rise include the crack cocaine epidemic and the high incidence of prostitution among drug users.3 One study reported a substantial epidemiological correlation between the acquisition and transmission of the HIV virus and Syphilis.4
Multiple clinical stages and long periods of latent, asymptomatic infection are characteristic of Syphilis. Primary Syphilis is defined by the presence of a chancre at the site of inoculation. The antibodies response to the TP bacterium can be detected within 4 to 7 days after the chancre appears. The infection remains detectable until the patient receives adequate treatment.5
The Syphilis Rapid Test (Whole Blood/Serum/Plasma) utilizes a double antigen combination of a Syphilis antigen coated particle and Syphilis antigen immobilized on membrane to detect TP antibodies (IgG and IgM) qualitatively and selectively in whole blood, serum or plasma.
Company Details
Business Type:
Manufacturer
Year Established:
2012
Total Annual:
500000-1000000
Employee Number:
150~200
Ecer Certification：
Active Member
Hangzhou Aichek Medical Technology Co.,Ltd Hangzhou Aichek Medical Technology Co.,Ltd is a high-tech company specialises in manufacturing rapid diagnostic and healthcare products. With five product lines of fertility, infectious diseases, cardiac marker, tumor marker and drug of... Hangzhou Aichek Medical Technology Co.,Ltd Hangzhou Aichek Medical Technology Co.,Ltd is a high-tech company specialises in manufacturing rapid diagnostic and healthcare products. With five product lines of fertility, infectious diseases, cardiac marker, tumor marker and drug of...
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