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Basic Info.
Model NO.
EC-FFN
Function
Early Detection
Display
Screening
Format
Strip+Bottle
Name
Ffn Test Kit
Equipment
by Eye or Machine
Reaction Time
5-10 Seconds
Accuracy
99.7%
Delivery Time
3-5 Days
Temperature
4-30 Degree
Storage
Room Temperature
Transport Package
Carton
Specification
64*50*44 cm
Trademark
evancare or OEM
Origin
China
HS Code
3002150090
Production Capacity
100000PCS/Day
Product Description
EVANCARE Diagnostic Fetal Fibronectin Rapid Test Kit (Swab)
For professional and in vitro diagnostic use only.
For professional and in vitro diagnostic use only.
[INTENDED USE]
The Fetal Fibronectin Rapid Test Cassette is a lateral flow immunoassay for
the qualitatively detect Fetal fibronectin from cervical secretions. This kit is
intended to be used as an aid in the diagnosis of preterm birth (22~35
weeks).
[PRINCIPLE]
The Fetal Fibronectin Rapid Test Cassette is a qualitative membrane strip
based immunoassay for the detection of Fetal Fibronectin directly from
cervix swab specimens. In this test procedure, anti-fFN antibody is
immobilized in the test line region of the device. After a specimen is placed in
the specimen well, it reacts with anti- fFN antibody coated particles that have
been applied to the specimen pad. This mixture migrates
chromatographically along the length of the test strip and interacts with the
immobilized anti-fFN antibody. If the specimen contains fFN, a colored line
will appear in the test line region indicating a positive result. A positive result
can indicate that the risk of premature delivery increases in the next two
weeks. If the specimen does not contain fFN, a colored line will not appear in
this region indicating a negative result. A negative result means that there is
little possibility of preterm labour within the next 7 to 10 days, and the test
can be repeated weekly for women who remain at high risk. A negative fetal
fibronectin test gives a more than 95% likelihood of remaining undelivered
for the next 2 weeks. To serve as a procedural control, a colored line will
always appear at the control line region indicating that proper volume of
specimen has been added and membrane wicking has occurred.
.
Positive: *Two lines appear. One colored line should be in the control
region (C), and another apparent colored line adjacent should be in the test
region (T).
Negative: One colored line appears in the control region (C). No line
appears in the test region (T).
Invalid: Control line fails to appear. Insufficient specimen volume or
incorrect procedural techniques are the most likely reasons for control line
failure. Review the procedure and repeat the test using a new test cassette.
If the problem persists, discontinue using the lot immediately and contact
your local distributor.
| Item No. | EVANCARE Diagnostic Fetal Fibronectin Rapid Test Kit (Swab) |
| Contents |
Each bag:1 test cassette and 1 desiccant(cassette)
We can put instruction as your requirement |
| Format / Size |
Cassette:2.5mm 3.0mm 4.0mm
|
| Methodology | Sandwich Colloidal Gold |
| Assay Type | Qualitative Detection |
| Specimen | Antigen (Swab), |
| Indicator | Fetal Fibronectin Test Cassette |
| Storage Temperature | 4-30 degree centigrade |
| Expiry date | 3 years |
| Certificate | CE,ISO,FREE SALE,FDA... |
| Detection Limits | Home or Professional Use
|
| Accuracy | > 99.99% |
| Reaction Time | 3-5 min |
| Delivery | 5-7 days |
| OEM Service | Available |
| Shipping Method | by air or sea or international express |
