One Step Pregnancy Ffn (fetal Fibronectin) Rapid Test Cassette Kits

• Customization: Available
• Type: IVD Reagent
• Certificate: CE, ISO
• Model NO.: EC-FFN
• Method: Colloidal Gold Rapid Test
• Warranty: 3 Years
• Material: Medical Grade ABS Plastic
• Package: Bottle + Carton
• 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

 

Product Description

EVANCARE Diagnostic Fetal Fibronectin Rapid Test Kit (Swab)

 

 

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.

 

 

 

 

 

 

 

 

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Detailed Photos

  

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)                  25 cassettes+2 Buffer  /box antigen test      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

Company Profile

 

Certifications

 

Product Procedure

 

 

Activity Exhibition

FAQ