Identify patient according to patient identification policy. <= /o:p>

·<= span style=3D'font:7.0pt "Times New Roman"'> = Po= sition patient flat on back.

·<= span style=3D'font:7.0pt "Times New Roman"'> = Co= llect sample of vaginal secretions using sterile vaginal swab provided in kit.

·<= span style=3D'font:7.0pt "Times New Roman"'> = Re= move swab from packaging using care not to touch anything prior to insertion into vagina.

·<= span style=3D'font:7.0pt "Times New Roman"'> = Co= llect sample from surface of vagina, holding swab in the middle of the stick while patient is lying flat on back.

·<= span style=3D'font:7.0pt "Times New Roman"'> = Ca= refully insert the polyester tip of the swab into the vagina until fingers contact = the skin no more than 2-3 inches (5-7 cm) deep.

· Wi= thdraw the swab after 1 minute.=

· Ri= nse swab after collection in solvent vial for 1 minute, and dispose of as indic= ated using standard precautions.

·<= span style=3D'font:7.0pt "Times New Roman"'> = Ti= ghtly close the sample vial, label with proper patient information and send to th= e laboratory to be tested as soon as possible after collection.

·<= span style=3D'font:7.0pt "Times New Roman"'> = If patient sample is not tested within 30 minutes and sample storage is necess= ary, place in ice water for no more than 8 hours.

AmniSure Test Information

· AmniSure test kit is for the in vitro detect= ion of human amniotic fluid PAMG-1 protein in vaginal secretion of pregnant women. The test should be use= d to evaluate patients with clinical signs/symptoms suggestive of fetal membranes rupture.

· Until the diagnosis of membrane rupture is excluded, avoid digital cervical examination to prevent infection and short= en the latency period.

· Exclusion criteria include active vaginal bleeding from any source and placenta previa.

· Interrupted leakage with minimal residual fl= uid can lead to false negative result.

· Each test is a single use disposable unit and cannot be reused.

· The results obtained are qualitative and no quantitative interpretation should be made based on the results.

· Presence of blood, collected with the swab, = can lead to a false positive result.

· In very rare cases when a sample is taken 12 hours or later after a rupture, a false negative result may occur due to the obstruction of fetus or resealing of the amniotic sac.

· AmniSure should not be used earlier than 6 h= ours after the removal of any disinfectant solutions or medicines from the vagin= a.

· Test performance in patients without signs or symptoms of ROM is unknown.

· Results should always be used in conjunction with other clinical information.

· Bleeding, placenta previa and performing dig= ital exams prior to sample collection can lead to inaccurate test results.

· Women may labor spontaneously despite a nega= tive test result.

AmniSure Interfering Substances

· Vaginal infections or urine do not interfere with the results of the AmniSure test.

· The performance of AmniSure has not been established in the presence of the following contaminants: meconium, anti-fungal creams or suppositories, K-Y Jelly, Baby Powder (Starch and Tal= c), Replens, and Baby Oil.

· Studies have shown that there is no interfer= ence of sperm factor in results.

Document Control

Facility: Central Maine Med= ical Center, 300 Main Street, Lewiston, Maine&n= bsp; 04240

Document Path\Filename:

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