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Funworld fFN Rapid Test Device for Wholesale


Short Description:

The fetal fibronectin (fFN) rapid test (vaginal secretion) is a visually interpreted, qualitative

immunochromatographic test device for detection of fFN in vaginal secretions during pregnancy, which is a special protein that literally holds your baby in place in the womb. The test is intended for professional use to help diagnose the rupture of fetal membranes (ROM) in pregnant women.



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PROCEDURE

fFN Rapid Test Device
Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.
1) Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test
with patient or control identification. To obtain a best result, the assay should be
performed within one hour.
2) Add the extracted buffer into the sample well. As the test begins to work, you will see
color move across the membrane.
3) Wait for the colored band to appear. The result should be read at 10 minutes. Do not
interpret the result after 20 minutes.

fFN Rapid Test Strip
Bring tests, specimens, buffer and/or controls to room temperature (15‐30°C) before use.
1) Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test
with patient or control identification. To obtain a best result, the assay should be
performed within one hour.
2) Hold the label area and put the strip into the extracted buffer towards the arrow label.
Leave the strip into the buffer until you see the liquid front enter the result area.
Remove the strip from the solution and place it in a horizontal position.
3) As the test begins to work, you will see color move across the membrane.
4) Wait for the colored band to appear. The result should be read at 10 minutes. Do not
interpret the result after 20 minutes

PRECAUTIONS

• For professional in vitro diagnostic use only.
• Do not use after expiration date indicated on the package. Do not use the test if its foil pouch is damaged. Do not reuse tests.
• This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary
state of the animals does not totally guarantee the absence of transmissible pathogenic agents.
It is therefore, recommended that these products be treated as potentially infectious, and
handled observing the usual safety precautions (do not ingest or inhale).
• Avoid cross-contamination of specimens by using a new specimen collection container for
each specimen obtained.
• Read the entire procedure carefully prior to performing any tests.
• Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all
specimens as if they contain infectious agents. Observe established precautions against
microbiological hazards throughout the procedure and follow the standard procedures for
proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable
gloves and eye protection when specimens are assayed.
• Buffered Saline contains sodium azide which may react with lead or copper plumbing to form
potentially explosive metal azides. When disposing of buffered saline or extracted samples,
always flush with copious quantities of water to prevent azide build up.
• Do not interchange or mix reagents from different lots.
• Humidity and temperature can adversely affect results.
• The used testing materials should be discarded in accordance with local, state and/or federal
regulations.

PRODUCT SPECIFICATION

INTERPRETATION OF RESULTS

 236346

POSITIVE: * A colored band appears in the control band region (C)

and another colored band appears in the T band region.

NEGATIVE RESULT:

NEGATIVE: One colored band appears in the control band region (C).

No band appears in the test band region (T).

INVALID RESULT:

Control band fails to appear. Results from any test which has not

produced a control band at the specified reading time must be

discarded. Please review the procedure and repeat with a new test.

If the problem persists, discontinue using the kit immediately and

contact your local distributor.

NOTE:

1. The intensity of the color in test region (T) may vary depending on the concentration of aimed

substances present in the specimen. Therefore, any shade of color in the test region should be

considered positive. Besides, the substances level can not be determined by this qualitative

test.

2. Insufficient specimen volume, incorrect operation procedure, or performing expired tests are

the most likely reasons for control band failure.


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