Intended use
This device is intended to be used for the in vitro qualitative detection of antibodies against Treponema Pallidum (TP) in human whole blood, serum or plasma. And it is for professional use only, not for self-testing of untrained individuals, nor for near-patient testing.
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. 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. Some key factors that have contributed to this rise include the crack cocaine epidemic and the high incidence of prostitution among drug users. One study reported a substantial epidemiological correlation between the acquisition and transmission of the HIV virus and Syphilis. 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.
The current clinical methods for detecting TP include chemiluminescence, immunochromatography and so on.
PRODUCT PARAMETER
TEST INFORMATION | |||
Method | Microfluidic Fluorescent Immunoassay | Test | LYOFIA® TP-Ab |
Format | Cassette | Reaction Time | 10min |
Linearity | - | Reference | Negative ≤ 1 |
Sample | WB / S / P | Certificate | CE |
ORDERING | |||||
Cat. No. | LMINTP25 | Applicable analyzer | LYOFIA-I, LYOFIA 8, | Kit Size | 25T |
Cat. No. | LAINTP25 | Applicable analyzer | LYOFIA 100 (Full-Automatic) | Kit Size | 25T |
APPLICATION SCENARIOS
Hospitals
Laboratory
Clinics
Ambulance
Cardiology
Pediatrics
Emergency
CSC
FAQ
Q: How long is the usual delivery time?
A: The regular delivery time is about 2 weeks. If you need to do new packaging (OEM), the delivery time for the first order is 25-30 days, and the second order starts and the regular delivery time is the same.
Q: Can reagents from different batches be mixed?
A: No.
Q: Are the results of CRP, SAA whole blood and peripheral blood the same?
A: Our laboratory big data test results show that the test results of CRPSAA on whole blood and fingertip blood are consistent. In the process of detecting fingertip blood, the inspecting doctor should try to avoid inhaling impurities such as subcutaneous tissue, which may lead to deviations in the test results.
This question is placed under the two products of CRP and SAA.
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