Medical Grade Disposable fFN Rapid Test Kit Fetal Fibronectin Rapid Detection,Colloidal Gold Antigen Rapid Test

Medical Grade Rapid Detection Of Fetal Fibronectin (fFN)

The fetal fibronectin (fFN) rapid test (private parts secretion) is a visually interpreted, qualitative immunochromatographic test device for detection of fFN in private parts 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.

Detection Principle

The fFN (private parts secretion) has been designed to detect fFN thrisough visual interpretation of color developmentin the internal strip. Themembranewas immobilizedwithanti-fFNantibodies on the test region.During the test, the specimen is allowed to react with colored anti-fFNantibodies colloidal gold conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membraneby a capillaryaction, andinteractwithreagentsonthemembrane.IftherewereenoughfFN in specimens, a colored band will form at the T region of the membrane. Presence of colored band indicates a positive result,while its absence indicates a negative result.Appearance of a colored bandat the control region serves as a procedural control. This indicates that proper volume of specimen has beenaddedandmembranewickinghasoccurred.

SPECIMEN COLLECTION AND STORAGE

• The Fetal fibronectin (fFN) rapid test (private parts secretion) is intended only for use with womenprivate partssecretionspecimens.
• The specimen is cervicoprivate parts secretion that is extracted into the Specimen Extraction Solution provided. A private parts secretion sample is obtained using a sterile polyester swab from the posterior fomix of the private parts during a sterile speculum examination or, if no private parts fluid is visible, the sample may be taken from the cervix. Take not to touch anything with the swab before taking the sample. The swab should be left in the private parts or cervix for approximately 10~15 seconds to allow it to absorb the secretion samples.
• Open the Specimen Extraction Solution tube and put it in a vertical position. The specimen is extracted immediately from the swab by swirling the swab vigorously in the extraction solution for approximately 10 seconds. Specimens should be tested as soon as possible after extraction but in any case no more than 4 hours after specimen collection and extraction. If a specimen can not be tested within this time it should be frozen. After thawing, the specimens can be tested as described below.
• Perform the testing immediately after the specimen collection. Do not leave the specimens at room temperature for prolonged periods. Specimens may be stored at 2- 8°C for up to 72 hours.
• Bring specimens to room temperature prior to testing.
• Pack the specimens in compliance with applicable regulations for transportation of etiological agents, in case they need to be shipped.

PROCEDURE

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.

INTERPRETATION OF RESULTS

NOTE:

1. The intensity of the color in test region (T) may vary depending on the concentrationofaimed substances present in the specimen. Therefore, any shade of color inthetestregion should be considered positive. Besides, the substances level cannotbedetermined by this qualitative test.
2. Insufficient specimen volume, incorrect operation procedure, or performingexpiredtests are the most likely reasons for control band failure.

LIMITATIONS OF THE TEST

1. The Fetal fibronectin (fFN) rapid test (private parts secretion) is for professional invitrodiagnostic use, and should be used for the qualitative detection of fFNonly.
2. As with all diagnostic tests, a definitive clinical diagnosis should not be basedontheresults of a single test, but should only be made by the physician after all clinical andlaboratory findings have been evaluated.
3. If the test result is negative and clinical symptoms persist, additional testingusingother clinical methods is recommended. A negative result does not at anytimeprecludethe possibility

Preservation and stability of products

1. Thekit shouldbe storedat 2-30°C untilthe expirydateprintedon thesealedpouch.
2. The test must remain in the sealed pouch until use.
3. Do not freeze.
4. Cares should be taken to protect components in this kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipments,containersor reagentscanleadtofalseresults.

KIT COMPONENTS

• Individually packed test strips Each strip contains colored conjugates and reactive reagents pre-spreaded at the corresponding regions.
• Specimens collection swab For specimens collection use.
• Specimens dilution tube with buffer 0.1 M Phosphate buffered saline (PBS) and preservative
• Package insert For operation instruction.

MATERIALS REQUIRED BUT NOT PROVIDED

• Timer For timing use.