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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 # |
PAP AND HPV HIGH RISK PCR
Test CodeLAB2339
Preferred Specimen
1 pap sample collected in ThinPrep® vial
Minimum Volume
1 ThinPrep® pap sample • 1 SurePath™ pap sample
Other Acceptable Specimens
1 SurePath™ pap sample collected in SurePath™ vial
Instructions
Collect the sample as usual according to the manufacturer's instructions.
For instructions refer to:
//www.questdiagnostics.com/dms/Documents/Other/Specimen_Collection_and_Transport_Guide_2019.pdf
For instructions refer to:
//www.questdiagnostics.com/dms/Documents/Other/Specimen_Collection_and_Transport_Guide_2019.pdf
Transport Container
ThinPrep® pap vial
Transport Temperature
Room temperature
Specimen Stability
ThinPrep® pap sample
Room temperature: 90 days
Refrigerated: 90 days
Frozen: Unacceptable
SurePath™ pap sample
Room temperature: 28 days
Refrigerated: 90 days
Frozen: Unacceptable
Room temperature: 90 days
Refrigerated: 90 days
Frozen: Unacceptable
SurePath™ pap sample
Room temperature: 28 days
Refrigerated: 90 days
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Received frozen • SurePath™ pellet • Samples treated with Acetic Acid • Vaginal sources • Samples from patients who have undergone a hysterectomy
Methodology
Polymerase Chain Reaction (PCR)
Setup Schedule
Report available: 2-3 days
Report Available
2-3 days
Clinical Significance
This test is used for the detection of high-risk Human Papillomavirus in clinician-collected cervical samples and can be used as part of an HPV primary screening algorithm. The test detects high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68, which are reported out as HPV 16, HPV 18, and other high-risk HPV types which includes, but does not differentiate, the remaining 12 high-risk types. Interim guidance supports the use of an HPV primary screening algorithm, where high-risk HPV testing is used as a first line screen, in women ≥25 years of age [1].
Patients should be followed-up in accordance with professional medical guidelines, results from prior screening, medial history, and other risk factors.
Specimens collected in SurePath collection devices have not been validated for use in HPV primary screening algorithms. If utilizing HPV primary screening algorithms, specimens collected in ThinPrep collection devices are approved by the Food and Drug Administration (FDA).
1. Huh WK, Ault KA, Chelmow D, et al. Use of primary high- risk human papillomavirus testing for cervical cancer screening: interim clinical guidance. Obstet Gynecol. 2015;125(2):330-337. doi:10.1097/AOG.0000000000000669
Patients should be followed-up in accordance with professional medical guidelines, results from prior screening, medial history, and other risk factors.
Specimens collected in SurePath collection devices have not been validated for use in HPV primary screening algorithms. If utilizing HPV primary screening algorithms, specimens collected in ThinPrep collection devices are approved by the Food and Drug Administration (FDA).
1. Huh WK, Ault KA, Chelmow D, et al. Use of primary high- risk human papillomavirus testing for cervical cancer screening: interim clinical guidance. Obstet Gynecol. 2015;125(2):330-337. doi:10.1097/AOG.0000000000000669
