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Genotyping by Luminex - Mucosal Types

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Accredited by the Standards Council of Canada to Laboratory no. 594 (ISO/IEC 17025)

Requisition Forms

Reference Details

Description:

Genotyping by in-house Luminex assay for mucosal Human Papilloma Viruses.

Test Category:
Genotyping
Pathogen:
Mucosal Human Papilloma virus (HPV)
Illnesses and Diseases:
  • Genital, anal and oropharyngeal cancers, and other mucosal lesions of HPV aetiology
Specimen:

Genital, anal, oro-pharyngeal specimens, and biopsies. Other specimen types may be accepted upon request.  No genital warts. The minimum volume required is 1/4 of the collected sample (for liquid-based cytology (LBC) samples, this amounts to 5mL of ThinPrep PreservCyt sample or 2mL of Surepath sample).  For fixed tissue, please submit 5 scrolls or entire block.   Please see patient criteria below for submission of mucosal lesions.

Collection Method:

Cervical cytobrushes in ThinPrep PreserCyt or Surepath solutions.  Swabs for genital, anal and oro-pharyngeal specimens in transport medium. Swabs for condyloma acuminatum or other visible lesions in transport medium.  Fresh biopsy or fixed tissue of any lesion.

Specimen Processing, Storage and Shipping:

Place swabs in 2mL or less of transport medium and provide entire collected specimen, or no less than ¼ of specimen.  Specimens collected by cytobrush and swab may be stored and shipped refrigerated to NML within 48h of specimen collection or must be stored and shipped frozen. LBC specimens may be stored at room temperature or 4°C and shipped at room temperature.  Fresh biopsies must be always stored frozen and shipped on dry ice.  Fixed tissue may be stored and shipped at room temperature.

Transportation of Dangerous Goods:

Shipping of specimens shall be done by a TDG certified individual in accordance with TDG regulations. For additional information regarding classification of specimens for the purposes of shipping, consult either Part 2 Appendix 3 of the TDG Regulations or section 3.6.2 of the IATA Dangerous Goods Regulations as applicable.

 

 

Patient Criteria:

This service is offered for reference and confirmation only when HPV genotyping is required to confirm a diagnosis of cancer or oropharyngeal lesions. This test is unsuitable for HPV cervical cancer screening. Samples for routine cervical cancer screening, ASCUS triage, or genital wart differential diagnosis are not accepted, unless part of a pre-arranged collaborative study. Please describe the anatomical site, the type of lesion, the type of specimen and the reason for testing. This information is necessary to assess if requests are within our mandate. This test does not detect HPV types that cause common warts and other skin lesions.

Accompanying Documentation:

Completed “Viral STI, Polyoma and Herpesvirus Testing” requisition form including sender lab name, address and telephone number, patient identifier, date of birth or age, sex, specimen reference #, anatomical site, type of specimen, type of lesion, date collected, test requested, reason for testing, and any other relevant clinical information.

Comments:

N/A

Methods and Interpretation of Results:

Nested PCR followed by genotyping using Luminex technology (1) (www.luminexcorp.com). The precise HPV type(s) are reported. Presence of additional types other than the ones reported cannot be excluded. The detection limit is between 10 and 100 copies for most mucosal HPV types. This assay detects the following HPV types: High Risk: 16, 18, 26, 30, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 67, 68, 68, 69, 70, 73, 82, 85, 97 (Sufficient or limited evidence for human carcinogenesis according to IARC, Bouvard et al Lancet Oncol. 2009; 10:321-322) and other types of low or unknown risk: 6, 11, 13, 32, 40, 42, 43, 44, 54, 61, 62, 71, 72, 81, 83, 84, 86, 87, 89, 90, 91. Please note that when testing formalin-fixed specimens, the presence of HPV may not be detected due to the decreased sensitivity of the assay. Direct sequencing is also available on special request. Call in advance for information.

Turnaround Time:

21 calendar days. Please contact lab to inquire about shorter turn around time.

Contact:
Phone #: (204) 789-6024
Fax: (204) 318-2222
References:
  1. Zubach V, Smart G, Ratnam S, Severini A. 2011. Novel microsphere-based method for the detection and typing of 46 mucosal human papillomavirus types. J. Clin Microbiol. 50(2): 460-4