Human Papillomavirus (HPV)

Molecular Biology - Infectious Diseases

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, only a subset of 13 to 18 of these types is considered high-risk for the development of cervical cancer and its precursor legions.

Although persistent infection with high-risk (HR) HPV is a necessary cause of cervical cancer and its precursor lesions, a very small percentage of infections progress to these disease states. Sexually transmitted infection with HPV is extremely common, with estimates of up to 75% of all women experiencing HPV at some point. However, > 90% of infected women will mount an effective immune response and clear the infection in 6 to 24 months without any long-term health consequences.

Nucleic acid (DNA) testing by PCR is a non-invasive method for determining the presence of a cervical HPV infection. The implementation of HPV DNA testing has increased the efficiency of cervical cancer screening programs by detecting high-risk lesions earlier in women 30 years and older with NILM cytology and by reducing the need for unnecessary colposcopy and treatment in patients 21 and older with ASC-US (abnormal) cytology.

Sample Type:

Sample Type: Cervical smear in ThinPrep PreservCyt Solution.

The total volume of sample in the tube should be at least 3ml.

Turnaround Time:

10 working days from sample receipt for co-testing (all samples sent to Eurofins NMDL, The Netherlands for cytology following HPV testing).

Sample Stability:
Instrument / Procedure:

The cobas® 4800 HPV Test is a qualitative in vitro test for the detection of HPV in patient specimens, The test utilises amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridisation for the detection of 14 HR HPV types in a single analysis. The test specifically identifies HPV 16 and HPV 18 while concurrently detecting the other high-risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) at clinically relevant infection levels.

Units:
Reference Range:

HPV16 and/or HPV18 and/or Other HR HPV

  • Detected
  • Not Detected
  • Invalid
Precautions:

None for patient. Media is classified as hazardous, adequate PPE for the person taking the sample.

Preparation of patient:

Patient should avoid using any vaginal medications, lubricants or creams in the 2 days prior to the sample being taken.

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Accredited
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SAMPLE REQUIREMENTS FOR COAGULATION TESTS

PROCEDURE

Sample Requirements and Collection

  • Patients should be relaxed pre-venepuncture. Excessive stress and exercise will increase FVIII, vWF antigen and fibrinolysis. Venous occlusion should be avoided.
  • Difficult venepuncture with trauma may lead to platelet activation with release of PF4 fromalpha granules.
  • Venous blood should be collected into coagulation tubes containing Sodium Citrate 3.2%, 0.105M, 3ml.
  • Specimens must be mixed immediately post venepuncture to avoid clot activation, by GENTLY inverting the tubes 5 to 10 times.
  • The ratio of whole blood to anticoagulant is crucial. Under-filled specimens will not be processed as over- or under-filled tubes can adversely affect results.
  • Any warfarin treatment should be mentioned on the request form.

Transportation and Storage

  • PT/INR specimens should ideally be analysed within 12 hours of collection and transported to the laboratory at room temperature.
  • APTT and Fibrinogen should ideally be analysed within 4 hours of collection. Where this is not possible please centrifuge at room temperature (RT) @3000rpm (1500g) for at least 15 minutes, and then carefully remove the plasma from the cells, transfer to a fresh plastic plain tube and freeze at -20oC.
  • Non-frozen coagulation specimens should be transported at RT ASAP to avoid deterioration of labile factors V and VIII.
  • Collection of blood through intravenous lines that have been previously flushed with heparin should be avoided. In the event blood is drawn from an indwelling catheter, the line should be flushed with 5ml of saline, and the first 5ml of blood or 6 times the line volume be drawn off and discarded before coagulation tube is filled.

Plasma Sample Stability (CLSI H21-A5)

  • PT 24 hours @ RT or 2 weeks @ -20oC
  • APTT 4 hours @ RT or 2 weeks @ -20oC & 12 Months @ -70oC
  • Fibrinogen - 4 hours @ RT `

ESR Ref Ranges
Units of Measurement
MALE
FEMALE
>50 Years
mm/hr
0 - ≤12
0 - ≤15
<50 Years
mm/hr
0 - ≤8
0 - ≤10
Analyte
Units of Measurement
MALE
FEMALE
WBC
10^9/L
4.0 - 10.0
4.0 - 10.0
RBC
10^12/L
4.5 - 5.5
3.8 - 4.8
HB
g/dL
13.0 - 17.0
12.0 - 15.0
HCT
L/L
0.400 - 0.500
0.360 - 0.460
MCV
fL
83 - 101
83 - 101
MCH
pg
27 - 32
27 - 32
MCHC
g/dL
31.5 - 34.5
31.5 - 34.5
PLT
10^9/L
150 - 410
150 - 410
MPV
fL
N/A
N/A
RDW
%
11.6 - 14.0
11.6 - 14.0
#Neut
10^9/L
2.0 - 7.0
2.0 - 7.0
#Lymph
10^9/L
1.0 - 3.0
1.0 - 3.0
#Mono
10^9/L
0.2 - 1.0
0.2 - 1.0
#Eos
10^9/L
0.02 - 0.50
0.02 - 0.50
#Baso
10^9/L
0.02 - 0.10
0.02 - 0.10
Analyte
Units of Measurement
MALE
FEMALE
WBC
10^9/L
Up to 1 year (6.00-16.00)
Up to 6 years (5.00-15.00)
Up to 12 years (5.00-13.00)
Up to 18 years (3.88-10.49)
Up to 1 year (6.00-16.00)
Up to 6 years (5.00-15.00)
Up to 12 years (5.00-13.00)
Up to 18 years (3.88-10.49)
RBC
10^12/L
Up to 1 year (3.90-5.10)
Up to 12 years (4.00-5.20)
Up to 18 years (4.28-5.59)
Up to 1 year (3.90-5.10)
Up to 12 years (4.00-5.20)
Up to 18 years (3.73-5.02)
HB
g/dL
Up to 1 year (11.1-14.1)
Up to 6 years (11.0-14.0)
Up to 12 years (11.5-15.5)
Up to 18 years (13.5-17.2)
Up to 1 year (11.1-14.1)
Up to 6 years (11.0-14.0)
Up to 12 years (11.5-15.5)
Up to 18 years (11.3-15.2)
HCT
L/L
Up to 1 year (0.300-0.380)
Up to 6 years (0.340-0.400)
Up to 12 years (0.350-0.450)
Up to 18 years (0.381-0.499)
Up to 1 year (0.300-0.380)
Up to 6 years (0.340-0.400)
Up to 12 years (0.350-0.450)
Up to 18 years (0.323-0.462)
MCV
fL
Up to 1 year (72.0-84.0)
Up to 6 years (75.0-87.0)
Up to 12 years (77.0-95.0)
Up to 18 years (83.1-99.1)
Up to 1 year (72.0-84.0)
Up to 6 years (75.0-87.0)
Up to 12 years (77.0-95.0)
Up to 18 years (83.1-99.1)
MCH
pg
Up to 1 year (25.0-29.0)
Up to 6 years (24.0-30.0)
Up to 12 years (25.0-33.0)
Up to 18 years (28.3-33.9)
Up to 1 year (25.0-29.0)
Up to 6 years (24.0-30.0)
Up to 12 years (25.0-33.0)
Up to 18 years (28.3-33.9)
MCHC
g/dL
Up to 1 year (32.0-36.0)
Up to 6 years (31.0-37.0)
Up to 12 years (31.0-37.0)
Up to 18 years (32.1-36.6)
Up to 1 year (32.0-36.0)
Up to 6 years (31.0-37.0)
Up to 12 years (31.0-37.0)
Up to 18 years (32.1-36.6)
PLT
10^9/L
Up to 1 year (200-550)
Up to 6 years (200-490)
Up to 12 years (170-450)
Up to 18 years (164-382)
Up to 1 year (200-550)
Up to 6 years (200-490)
Up to 12 years (170-450)
Up to 18 years (164-382)
RDW
%
No separate paediatric ranges
No separate paediatric ranges
#Neut
10^9/L
Up to 1 year (1.00-7.000)
Up to 6 years (1.50-8.00)
Up to 12 years (2.00-8.00)
Up to 18 years (1.56-6.52)
Up to 1 year (1.00-7.000)
Up to 6 years (1.50-8.00)
Up to 12 years (2.00-8.00)
Up to 18 years (1.56-6.52)
#Lymph
10^9/L
Up to 1 year (3.50-11.00)
Up to 6 years (6.00-9.00)
Up to 12 years (1.00-5.00)
Up to 18 years (1.01-3.13)
Up to 1 year (3.50-11.00)
Up to 6 years (6.00-9.00)
Up to 12 years (1.00-5.00)
Up to 18 years (1.01-3.13)
#Mono
10^9/L
Up to 1 year (0.20-1.00)
Up to 6 years (0.20-1.00)
Up to 12 years (0.20-1.00)
Up to 18 years (1.01-3.13)
Up to 1 year (0.20-1.00)
Up to 6 years (0.20-1.00)
Up to 12 years (0.20-1.00)
Up to 18 years (1.01-3.13)
#Eos
10^9/L
Up to 12 years (0.10-1.00)
Up to 18 years (0.05-0.51)
Up to 12 years (0.10-1.00)
Up to 18 years (0.05-0.51)
#Baso
10^9/L
Up to 1 day (0.00-0.64)
Up to 7 days (0.00-0.25)
Up to 14 years (0.00-0.23)
Up to 18 years (0.02-0.15)
Up to 1 day (0.00-0.64)
Up to 7 days (0.00-0.25)
Up to 14 years (0.00-0.23)
Up to 18 years (0.02-0.15)
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