28.0 HPV 16-18_45 Genotyping


Title of Manual: Specimen Collection

Version No: 1.1

Title: HPV 16,18/45 Genotyping

Effective Date: 11/01/09
Revised Date: 01/02/14

Document #: GPA.SPC.28.0


I. PURPOSE

To provide proper collection protocol for the testing of HPV genotypes 16 and 18/45.

II. MATERIALS

Reagents

Supplies

Equipment

Cervical sampling:
• CytoBrush & Spatula or
Broom in ThinPrep or SurePath
Liquid Based Collection

Oral Cavity/Oropharynx:
• CytoBrush in ThinPrep
Liquid Based Collection Vial.


III. PROCEDURE

ThinPrep or SurePath Liquid Based Pap Test:
One specimen will be used to provide samples for both the Pap test and/or the HPV 16/18 Genotyping test. Follow the appropriate Pap collection instructions for testing of cervical HPV Genotyping. HPV Genotyping can be performed after HR HPV detection from the same sample or as a separate stand-alone test.

Oropharyngeal HPV 16/18 Genotyping Test:
Obtain an adequate sampling from the oral cavity/oropharynx using a cyto-brush device and rotating the bristle a full turn around the lesion site. Rinse the brush as quickly as possible in the preservative solution by rotating the device in the solution 10 times while pushing against the vial wall. After swirling the brush vigorously to release the material, dispose of the brush. Tighten and label the vial.

IV. QUALITY CONTROL

• Minimum Volume:
    • 1 mL
• Storage Requirements:
    • Room Temperature
• Stability Requirements:
    • 4 Weeks

V. CALCULATIONS/CALIBRATION

VI. INTERPRETATIONS

VII. METHOD PERFORMANCE SPECIFICATIONS

VIII. REFERENCES

IX. RELATED DOCUMENTS

GPA HPV Standing Order Form E:9/1/13

X. DOCUMENT HISTORY

MINOR REVISION
(Laboratory Director’s Signature on Original Subsequent Document Attached)

X - MAJOR REVISION
(Requires Laboratory Director & Department Director Signature - where applicable)

Reason for Change

1/02/14 New Document Control Format



Laboratory Director

(Signature)

Date

Natalie Depcik-Smith, MD
(Print)



Department Director

(Signature)

Date


(Print)



Designee

Date

(Print)

(Signature)

(Print)

(Signature)

(Print)

(Signature)

(Print)

(Signature)

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(Signature)



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