OVERVIEW

Purpose: The Aptima HPV 16 18/45 genotype assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) of human papillomavirus (HPV) types 16, 18 and 45 in cervical specimens from women with Aptima HPV assay positive results. The Aptima HPV 16 18/45 genotype assay can differentiate HPV 16 from HPV 18 and/or HPV 45 but does not differentiate between HPV 18 and HPV 45. Cervical specimens in ThinPrep Pap Test vials containing PreservCyt Solution and collected with broom-type or cytobrush/spatula collection devices* may be tested with the Aptima HPV 16 18/45 genotype assay. The assay is used with the Tigris DTS System or the Panther System.

SPECIMEN COLLECTION

Specimen Requirements: Cervical cells in liquid-based cytology transport.

Specimen Source: Cervical.

Minimum Volume: Entire liquid cytology vial (>1ml).

Collection Method: Collect cervical specimens in ThinPrep Pap Test vials containing PreservCyt Solution with broom-type or cytobrush/spatula collection devices according to the manufacturer’s instructions.

TEST DETAILS

Methodology: The Aptima HPV 16 18/45 genotype assay involves three main steps, which take place in a single tube: target capture, target amplification by transcription-mediated amplification (TMA) and detection of the amplification products (amplicon) by the hybridization protection assay (HPA). The dual kinetic assay (DKA) is the method used to differentiate the HPV signals and the IC signal. IC and HPV 16 amplicon are detected by probes with rapid light-emission kinetics (flasher). The IC signal in each reaction is discriminated from the HPV 16 signal by the magnitude of the light emission. Amplicons specific to HPV 18 and 45 are detected using probes with relatively slower kinetics of light emission (glower). The assay is used with the Panther System.

Compliance Category: FDA approved test.

Reference Interval: Negative

Limitations:

• The Aptima HPV 16 18/45 genotype assay is not intended for use as a stand-alone assay. The assay should be performed only as a follow-up to an Aptima HPV assay positive result, and should be interpreted in conjunction with cervical cytology test results
• ThinPrep liquid cytology specimens containing less than 1 mL after ThinPrep Pap Test slide preparation are considered inadequate for the Aptima HPV 16 18/45 genotype assay
• A negative Aptima HPV 16 18/45 genotype assay result does not exclude the possibility of cytologic abnormalities or of future or underlying CIN2, CIN3, or cancer
• The Aptima HPV 16 18/45 genotype assay provides qualitative results. Analyte levels are not necessarily associated with S/CO values. High S/CO values may be observed in samples close to the detection limit of the assay and low S/CO values may be observed in samples above the detection limit. Performing multiple tests on a sample may yield different S/CO values
• Detection of high-risk HPV (types 16, 18, and 45) mRNA is dependent on the number of copies present in the specimen and may be affected by specimen collection methods, patient factors, stage of infection and the presence of interfering substances
• High concentrations of HPV 45 can reduce the ability of the Aptima HPV 16 18/45 genotype assay to detect the presence of HPV 16 at low levels
• Cross-contamination of samples can cause false positive results. The carryover rate of the Aptima HPV 16 18/45 genotype assay on the Panther System was 0.19%, as determined in non-clinical studies
• The Aptima HPV 16 18/45 genotype assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician

Sample Stability: 7 days at 37°C and 50°C, 14 days at room temperature, as well as refrigerated and frozen temperatures.

Turnaround Time: 98% < 72 hours, 50% < 24 hours

Directorship: Cheryl Hanau, MD; Garth Ehrlich, PhD, FAAAS, FAAM; Donald Hall Jr., PhD; Yinghua Qiu, PhD, DABCC

CPT Code: 87625

Review Date: 08/28/2023

SPECIMEN PROCESSING

Specimen Transport and Storage:

• ThinPrep liquid cytology specimens transferred to an Aptima Specimen Transfer tube may be stored at 2°C to 30°C for up to 60 days
• The ThinPrep liquid cytology specimen or the ThinPrep liquid cytology specimen diluted into the Aptima Specimen Transfer tube may be stored at -20°C to -70°C for up to 24 months

Rejection Criteria:

• Inappropriate specimen condition:
  • Incorrect patient identification
  • Unlabeled specimen
• Inappropriate specimen transport conditions:
  • Specimen leaked in transit
  • Specimen in expired transport or incorrect transport device
• ThinPrep liquid cytology specimens containing less than 1 mL
• Specimen stability limits exceeded

The information on these pages is provided for general information only and should not be used for diagnosis or treatment, or as a substitute for consultation with a physician or health care professional. If you have specific questions or concerns about your health, you should consult your health care professional.

 
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