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Clear
 
Test Code:
090-70-0060-01

Order Name:
hr HPV and 16/18 Screening (Female)

 
Useful For:
For use in screening patients with ASC-US (atypical squamous cells of undetermined significance) cervical cytology results to determine the need for referral to colposcopy. For use as a first-line primary screening test to identify women at increased risk for the development of cervical cancer or presence of high-grade disease.
 
Methodology:
Real Time Polymerase chain reaction (Real-Time PCR)
 
Test List In Profile:
HPV 16
HPV 18
Other high risk HPV genotypes
 
AliasesName:
High Risk HPV (hr HPV)
HPV (Human Papillomavirus) PCR
Human Papillomavirus (HPV) Genotyping
 
 
 
Test Code:
090-70-0060-01

Order Name:
hr HPV and 16/18 Screening (Female)

 
Collection Specimen Or Container:
Cervical cells/ PreservCyt® (ThinPrep liquid PAP vial) 20 mL, 1 vial
 
Specimen Testing Type:
Cervical cells in PreservCyt®solution, minimum volume 3 mL
 
Sub Mission Container:
Plastic tube
 
Rejection Criteria:
  1. Specimen volume less than minimum volume 3 mL will be reject.
  2. Specimens that appear bloody or have a dark brown color.
 
Specimen Stabillity:
Specimen Type Temperature Time
Cervical cells in PreservCyt®solution At temperature, 2oC to 30oC 6 months
 
 
 
Test Code:
090-70-0060-01

Order Name:
hr HPV and 16/18 Screening (Female)

 
Method detail:
Real Time Polymerase chain reaction (Real-Time PCR)
 
Schedule:
Test daily, at 09:00 a.m.
 
Turnaround Time:
Received specimen to reported within 2 days.
 
Performing Location:
Molecular biology & Genetics, Laboratory Department Tel.14168
 
Specimen Retention Time:
30 days
 
 
 
Test Code:
090-70-0060-01

Order Name:
hr HPV and 16/18 Screening (Female)

 
 
Clinical Information:
Persistent infection with human papillomavirus (HPV) is the cause of cervical cancer and its precursor cervical intraepithelial neoplasia (CIN). The presence of HPV has been implicated in greater than 99% of cervical cancers, worldwide. HPV is a small, non-enveloped, double-stranded DNA virus, with a genome of approximately 8000 nucleotides. There are more than 118 different types of HPV and approximately 40 different HPVs that can infect the human anogenital mucosa. However, data suggest that 14 of these types (HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) are considered high risk (HR) for the development of cervical cancer and its precursor lesions. Furthermore, HPV types 16 and 18 have been regarded as the genotypes most closely associated with progression to cervical cancer. HPV-16 is the most carcinogenic and is associated with approximately 60% of all cervical cancers, while HPV-18 accounts for approximately 10% to 15% of cervical cancers.
 
Reference Value:
Test Reference Value
HPV 16 Negative
HPV 18 Negative
Other high risk HPV genotypes Negative
 
Interpretation:
A positive result indicates the presence of human papillomavirus (HPV) DNA due to 1 or more of the following genotypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. A negative result indicates the absence of HPV DNA of the targeted genotypes. For patients with atypical squamous cells of undetermined significance (ASC-US) Pap smear result and who are positive for high-risk (HR) HPV, consider referral for colposcopy, if clinically indicated. For women aged 30 years and older with a negative Pap smear result but who are positive for HPV-16 and/or HPV-18, consider referral for colposcopy, if clinically indicated. For women aged 30 years and older with a negative Pap smear, positive-HR-HPV test result, but who are negative for HPV-16 and HPV-18, consider repeat testing by both cytology and a HR-HPV test in 12 months.
 
Clinical Reference:
Manufacturer’s package insert, cobas® 4800 HPV Test, January 2019, Roche Molecular Systems, NJ 08876 Branchburg, USA.