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| A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
Fetal Fibronectin
MessageSRHC Clients:
Specimens MUST be collected with the Dacron swab from Adeza Biomedical Corporation Specimen Collection Kit.
Specimens MUST be collected with the Dacron swab from Adeza Biomedical Corporation Specimen Collection Kit.
Test Code
FFN
CPT Codes
82731
Preferred Specimen
Specimens must be collected with the Dacron Swab obtained from Adeza Biomedical Corporation Specimen Collection Kit
Instructions
Collection from Symptomatic Women:
The specimen should be obtained from the posterior fornix of the vagina during a sterile speculum examination. The Dacron swab provided in the Specimen Collection Kit should be inserted into the vagina and lightly rotated across the posterior fornix for approximately 10 seconds to absorb the cervicovaginal secretions. Manipulation of the cervix may lead to false positive results. Specimens should be obtained prior to digital examination or manipulation of the cervix. Patients with suspected or known placental abruption, placenta previa, or moderate or gross vaginal bleeding should not be tested for fFN.
Collection from Asymptomatic Women:
The specimen can be obtained from either the posterior fornix of the vagina or the ectocervical region of the external cervical os during a sterile speculum examination.
The Dacron swab provided in the Specimen Collection Kit should be inserted into the vagina and lightly rotated across the posterior fornix or around the ectocervical region of the external cervical os for approximately 10 seconds to absorb the cervicovaginal secretions.
The specimen should be obtained from the posterior fornix of the vagina during a sterile speculum examination. The Dacron swab provided in the Specimen Collection Kit should be inserted into the vagina and lightly rotated across the posterior fornix for approximately 10 seconds to absorb the cervicovaginal secretions. Manipulation of the cervix may lead to false positive results. Specimens should be obtained prior to digital examination or manipulation of the cervix. Patients with suspected or known placental abruption, placenta previa, or moderate or gross vaginal bleeding should not be tested for fFN.
Collection from Asymptomatic Women:
The specimen can be obtained from either the posterior fornix of the vagina or the ectocervical region of the external cervical os during a sterile speculum examination.
The Dacron swab provided in the Specimen Collection Kit should be inserted into the vagina and lightly rotated across the posterior fornix or around the ectocervical region of the external cervical os for approximately 10 seconds to absorb the cervicovaginal secretions.
- Once the specimen is obtained, carefully remove the swab from the vagina or cervical os and place it into the tube of buffer provided with the Specimen Collection Kit.
- Break the shaft (at the score) even, with the top of the tube. Align the shaft with the hole inside the tube cap and push down tightly over the shaft, sealing the tube.
- Label the Specimen Transport Tube with the patient’s name and second identifier, sample barcode label and any other identifying information required
Transport Container
Specimen Transport tube provided with the Adeza Biomedical Corporation Specimen Collection Kit
Transport Temperature
Transport specimens at 2°C to 25°C.
It is ideal to transport specimens at 2°C to 8°C, however, the integrity of the specimen is maintained at temperatures up to 25°C for 8 hours. Exposure of the specimen to heat for even short periods of time can be detrimental. It is best to keep the specimen cool whenever possible.
It is ideal to transport specimens at 2°C to 8°C, however, the integrity of the specimen is maintained at temperatures up to 25°C for 8 hours. Exposure of the specimen to heat for even short periods of time can be detrimental. It is best to keep the specimen cool whenever possible.
Specimen Stability
- Specimens must be stored refrigerated at 2°C to 8°C and assayed within 3 days of collection to avoid degradation of fFN.
- Store in refrigerator, if testing is delayed.
- Avoid extreme temperatures.
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
- Specimens collected in or by any sample device other than the Adeza Biomedical Specimen Collection Kit.
- Specimens with insufficient volume for testing or without swab. Buffer volume and swabs must be at bottom of tube label or insufficient buffer is present.
- Specimens received unlabeled.
- Specimens received >3 days after the sampling date.
- Specimens received at temperatures >25 °C.
Methodology
Lateral flow, solid-phase immunosorbent assay
Setup Schedule
24/7
Limitations
The Rapid fFN result should not be interpreted as absolute evidence for the presence or absence of a process that will result in delivery in less than or equal to 7 or 14 days from specimen collection in symptomatic women or delivery in less than or equal to 34 weeks, 6 days in asymptomatic women evaluated between 22 weeks, 0 days and 30 weeks, 6 days of gestation. A positive Rapid fFN result may be observed for patients who have experienced cervical disruption caused by, but not limited to, events such as sexual intercourse, digital cervical examination, or vaginal probe ultrasound. The Rapid fFN result should always be used in conjunction with information available from the clinical evaluation of the patient and other diagnostic procedures such as cervical examination, cervical microbiological culture, assessment of uterine activity, and evaluation of other risk factors
Manipulation of the cervix may lead to false positive results. Specimens should be obtained prior to digital examination or manipulation of the cervix.
Care must be taken not to contaminate the swab or cervicovaginal secretions with lubricants, soaps, or disinfectants. These substances may interfere with absorption of the specimen by the swab or with the antibody-antigen reaction of the assay.
Test results are difficult to interpret if the specimen contains semen or if the specimen was collected less than 24 hours after coitus. Studies have shown that the presence of semen may lead to a false positive result.
Patients with suspected or known placental abruption, placenta previa, or moderate or gross vaginal bleeding should not be tested for fFN.
Manipulation of the cervix may lead to false positive results. Specimens should be obtained prior to digital examination or manipulation of the cervix.
Care must be taken not to contaminate the swab or cervicovaginal secretions with lubricants, soaps, or disinfectants. These substances may interfere with absorption of the specimen by the swab or with the antibody-antigen reaction of the assay.
Test results are difficult to interpret if the specimen contains semen or if the specimen was collected less than 24 hours after coitus. Studies have shown that the presence of semen may lead to a false positive result.
Patients with suspected or known placental abruption, placenta previa, or moderate or gross vaginal bleeding should not be tested for fFN.
Reference Range
Detection of Fetal Fibronectin (fFN) in cervicovaginal secretions is associated with preterm delivery in symptomatic pregnant women between 24 weeks and 34 weeks, 6 days gestation and in asymptomatic pregnant women 22 weeks to 30 weeks, 6 days gestation.
