Intended use
This device is intended to be used for the in vitro quantitative determination of fetal fibronectin (fFN) in human vaginal secretion specimens. And it is for professional use only, not for self-testing of untrained individuals, nor for near-patient testing.
Summary
Fetal fibronectin (fetal fibronectin, fFN) is a glycoprotein with a molecular weight of about 500KD and has 20 different molecular forms. fFN is produced in chorionic trophoblasts, mainly distributed in amniotic fluid, placental tissue and choriodecidua interface, and plays an important role in the mutual adhesion and protection of placenta and uterine decidua. [1] The positive fFN in cervical and vaginal secretions indicates that the adhesion between the placenta and the uterine decidua is damaged, indicating the separation of the lower uterine decidua and the fetal membranes, and the leakage of fFN into the vagina through the cervix is considered to be a part of the initiation of labor in a non-term pregnancy. high-risk indicators. [2]
The current clinical methods for detecting fFN include chemiluminescence, immunochromatography and so on.
PRODUCT PARAMETER
|
TEST PARAMETER |
|||
|
Method |
Microfluidic Fluorescent Immunoassay |
Test |
LYOFIA® fFN |
|
Format |
Cassette |
Reaction Time |
10min |
|
Linearity |
[20, 2000] ng/mL |
Reference Interval |
≤50 ng/mL |
|
Sample |
vaginal secretions |
Certificate |
CE |
|
ORDERING |
|||||
|
Cat. No. |
LMPEFF25 |
Applicable analyzer |
LYOFIA-I, LYOFIA 8, |
Kit Size |
25T |
|
Cat. No. |
LAPEFF25 |
Applicable analyzer |
LYOFIA 100 (Full-Automatic) |
Kit Size |
25T |
APPLICATION SCENARIOS
Hospitals
Laboratory
Clinics
Ambulance
Cardiology
Pediatrics
Emergency
CSC
FAQ
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.
Q: Is it possible to add emergency testing to our instrument in the middle of the testing process?
A: LYOFIA 100, DISKFLU 1000, these two instruments can achieve.
This question is placed under LYOFIA 100, DISKFLU 1000, these two products.
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