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 | Syphilis Rapid Test Kit Uncut Sheet ，Syphilis Test Uncut Sheet ，Uncut Sheet Syphilis Test Strips | ||
| Product Name |
Syphilis Rapid Test |
| Formats | Strip(3mm)Device(4mm) uncut sheet |
| Place of Origen | China |
| Specimen | Urine |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | uncut sheet |
| 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.
PRINCIPLE
The Syphilis Rapid Test (Whole Blood/Serum/Plasma) is a qualitative membrane based immunoassay for the detection of TP antibodies (IgG and IgM) in whole blood, serum or plasma. In this test procedure, recombinant Syphilis antigen is immobilized in the test line region of the test. After specimen is added to the specimen well of the device, it reacts with Syphilis antigen coated particles in the test. This mixture migrates chromatographically along the length of the test and interacts with the immobilized Syphilis antigen. The double antigen test format can detect both IgG and IgM in specimens. If the specimen contains TP antibodies, a colored line will appear in the test line region, indicating a positive result. If the specimen does not contain TP antibodies, a colored line will not appear in this region, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
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
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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