Laboratory overview

Each year, CervicalCheck laboratories process between 200,000 and 300,000 samples. The majority of CervicalCheck samples are currently analysed at Quest Diagnostics in Clifton, New Jersey, USA, with an increasing number being processed in Dublin at the new National Cervical Screening Laboratory (NCSL) at the Coombe Hospital.

A sample is viable for 42 days after it has been taken. After this it will not be processed by the lab. Therefore, a vial should have an expiry date which exceeds 42 days from the date of the test so that it will not expire while in transit. Always check the expiration date on the vial and remember the date is in the American format: MM/DD/YYYY. To allow for sample transit times, samples received in the collection point close to expiry date may be resulted as Test Not Processed (TNP)

Samples should be stored at room temperature and should not be refrigerated. Samples must be dispatched within three working days of the test being taken. Each sample along with the corresponding cervical screening form should be stored in the transport box provided by CervicalCheck and should be recorded in the practice log at the time it is placed in the box.

CervicalCheck supplies vial transport boxes which are available in different sizes; 10 vial, 6 vial and 2 vial. Choose a suitable size transport box depending on the number of samples you have to dispatch. Regardless of the number of samples taken, samples must be dispatched within three working days of the sample been taken. Do not wait until the transport box is full. It is a good idea to have a selection of transport box sizes in the surgery to allow for dispatch of varying sizes.

It is the responsibility of the sample taker/ clinically responsible doctor to post samples to the laboratory. A woman should never be asked to post her own sample.

Once a sample is taken it should be dispatched, along with the cervical screening form, within three working days. It is vital that a log of samples dispatched is maintained in the practice to ensure traceability.

The sample taker must maintain a record for each screening test taken. This ensures an efficient failsafe mechanism, particularly if follow-up is missed. A tracking system should record that:

• All screening tests are dispatched to the laboratory.
• All results are received from the laboratory.
• The woman has been informed if she receives an abnormal result.
• All laboratory recommendations are followed.

Samples taken on women who are not registered patients of the practice must be maintained in the same manner as those of registered patients.

Manual Records:

Manual records can be organised using a manual logbook.  Use a logbook to document the following:

• CSPID or name of women
• Date the screening test was taken
• Date the sample was posted
• Result received
• Information on the result being actioned, i.e. the woman has been informed and/or referral sent if applicable 

Example of what a log may look like: 

A designated person in the clinic should be responsible for checking that the logbook is completed at each stage and that all the appropriate actions have been taken.

Computerised Records:

The procedure for entering cervical screening tests will vary depending on the software package being used. Current GP software allows recording of screening test results and the production of reports listing screening tests taken, results received and screening tests due during certain defined periods. Practices should contact their technical support if necessary. Appropriate advice should be provided to all clinical people involved in the screening programme within the practice and one designated person should be responsible for ensuring that everybody has the necessary competence to enter data in the system.

Delay in transit: Dispatch sample within 3 working days and ensure there is adequate expiry on the vial i.e. in excess of 42 days viability. If there is a delay in transit, having a vial expiry date of ≥ 42 days will ensure the sample remains valid.

Missing sample: This is a very rare occurrence. Check to ensure that the sample has not been inadvertently mislaid in the practice and not sent. Contact the laboratory in case there has been any issue with the sample and/or courier service (if used) as appropriate. If a sample has to be repeated, ensure the minimum interval of 3 calendar months is adhered to.

Screenlink delivers screening kits and cervical screening forms to practices. Disposable speculae are provided by Williams Medical Supplies. Their contact details are below:

When the sample arrives in the specimen reception the screening form is date- and time-stamped. The specimen vial and cervical screening form is checked by lab staff.

• If all quality checks are passed, the specimen is labelled with a unique laboratory accession number.
• If any discrepancies or errors are identified, the sample is segregated, and contact will be made with the surgery/clinic to resolve the discrepancy.
• If resolved, a second date and time stamp will be applied to the cervical screening form and the specimen is labelled with unique laboratory accession number.

The specimen vial and cervical screening form is then checked by a second member of the laboratory staff.

The sample is then sent to the HPV laboratory and tested for the 14 high-risk HPV subtypes identified by the World Health Organization: HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. HPV types 16 and 18 are known to cause 70% of cervical cancers.

If high-risk HPV (hrHPV) is detected, the sample will be sent to the cytology laboratory where the sample is processed, reviewed for cytological changes and reported on.

In order to be accepted at the laboratory the vial must include, at a minimum, the woman's surname, first name, and date of birth. If a printed label is used, it must be adhered clearly to the existing label without obscuring the laboratory’s view of the liquid in the vial and without obscuring the manufacturer’s expiry dates on the vial label. All demographic details must exactly match the information on the cervical screening form.

The form must be completed accurately with the woman’s demographic details, the sample taker’s and CRD/Clinical Lead details, date of the sample and the woman’s signature or evidence of informed consent

Ensure you have checked the woman’s address for any updates as the address received on the cervical screening form will be entered on the woman’s cervical screening record and will be used for future correspondence to the woman from the programme.

The sample will not be processed if:

• If the information on the form does not match the information on the vial
• If the cervical screening form does not contain the woman’s signature/indication of consent for data transfer
• If the vial is unlabelled
• If the Clinically Responsible Doctor’s details are missing or incorrect and cannot be identified
• If the date of the screening test is not documented on the screening form
• If the sample site is not indicated on the screening form
• If the vial expiration date has passed or the sample is >42 days old

Most cases where issues are identified, the laboratory will contact the surgery and try to rectify the error. However, if this cannot be done safely, the sample will be rejected and the surgery will be informed to repeat the test in 3 calendar months.

A sample will be rejected and reported as Test Not Processed in the following scenarios:

• Sample vial is expired (manufacturer’s expiry).
• Sample has exceeded 42 days viability and has expired.
• The woman is under 25 years of age or over 65 years of age and is not eligible for screening.
• The sample has been repeated too soon, i.e. less than 3 calendar months since the last test received by the laboratory.
• Heavily bloodstained samples (lab will perform the appropriate assessment).

Other less common reasons include:

• Vial has leaked.
• Cervex broom head present in sample.
• If documented that the cervix has not been visualised.
• If the sample site is not clearly identified on the screening form.

When a sample is received and accepted, it is labelled with a unique laboratory accession number and it is entered on the Laboratory Information System (similar to any sample sent to a pathology laboratory for processing e.g. blood samples). The information is then also sent to CervicalCheck where it is uploaded on to the Cervical Screening Register (CSR).

Note: a woman’s clinical information  is not recorded on the CSR. For example, a woman living with HIV will need to have this information completed on the cervical screening form for each test she has done, as this information is not recorded on her screening file between tests.

Results are typically available in less than 4 weeks from the date of the test.

All cervical screening results are sent electronically to the doctor's surgery via HealthLink. No paper copies are generated for primary care. It is important that there is a designated person in the surgery who manages results received and updates the practice log to ensure all cervical screening tests taken have been reported on.

Every result received will have a management or recall recommendation. The receiving clinician should verify the accuracy of the recall recommendation. For more details, refer to the Cervical Screening results and recommendations table.

If you are missing any results, please contact the laboratory directly as they will have records of the screening test and will be able to answer your query.   

Recall recommendations are assigned based on the woman's age, previous screening history and in some cases are based on special medical circumstances. If you identify a result with an incorrect result recall recommendation, please contact the laboratory directly and they will review and may correct the recall recommendation. When changes are made, a replacement  result will be issued with the correct recall recommendation to your practice and the woman will receive an updated results letter from CervicalCheck. Cervical Screening results and recommendations table.

Remember if you do not complete the relevant clinical details on the screening form the laboratory will not have these details when applying the recall recommendation.

HPV platforms report error codes or flags where there is  insufficient volume or blood clots detected. These are reported as a HPV indeterminate result. If a sample contains excess blood, lubricant, or other contaminating substances, it becomes unsuitable for analysis. The lab will attempt to analyse the sample twice; if it fails both times, the result is reported as indeterminate.

The most common reasons for a cytology sample to be reported as unsatisfactory or inadequate is:

• Scant cellularity (most common and can be seen in post-menopausal women).
• Entire cervix not visualised (if cervix present).
• Cervix swabbed prior to test being taken.
• Presence of foreign material (e.g., lubricant).
• Obscuring inflammation.
• Obscuring blood.
• Excessive cytolysis or autolysis (broken cells usually caused by bacteria or excessive force used on broom when rinsing).
• Where there is a previous history of treatment for endocervical glandular abnormality and no endocervical glandular cells are seen (less common reason).

Please remember that a sample must not be repeated before the minimal 3 three- month interval, as this allows time for cells on the cervix to regenerate after a screening test.

Follow-up Actions: If a patient receives three consecutive indeterminate/unsatisfactory results, a referral for colposcopy is required, this recommendation will be applied to the relevant report by the laboratory.

A laboratory report may have added commentary on incidental findings relating  mainly to infections and the presence of endometrial cells. Incidental findings are not sent to CervicalCheck and any further investigation or follow up required is the responsibility of the doctor

The following infections might be reported:

• Candida infection present.
• Features suggestive of herpes infection.
• Organisms of actinomyces species present.
• Trichomonas (TV) infection present.

Endometrial cells present

• Endometrial evaluation & gynaecological assessment recommended- this comment will be added to the report when the patient is >45 years and endometrial cells are present regardless of the LMP

If endometrial cells are present in samples when the patient is >45 years you will see the following comment:

• Endometrial evaluation & gynaecological assessment recommended- this is comment to the report

If PCB, IMB or PMB is indicated on the screening form you will see the following comment:

• Refer to specialist gynaecology for opinion.

If non-cervical abnormalities co-existing with cervical abnormalities, i.e. presence of abnormal cells that may be from a site other than the cervix such as the endometrium, ovary or bowel, are seen in addition to having abnormal cervical cells (ASCUS and above). Dual pathology would also include identification of a non-cervical abnormality e.g. non-cervical carcinoma such as melanoma, metastatic carcinoma

• Please note dual pathology. (please be aware you will receive a phone call from the lab in this event)

No, genotyping is not performed  at present. Like other organised cervical screening programmes in England, Scotland, Wales and Northern Ireland, our guidelines recommend management based on a hrHPV positive result and the cytology result..

The WHO reviewed 7 different screening approaches, listed on page 63 of their guideline for cervical cancer screening (2nd edition), of which HPV DNA testing with cytology triage is a recommended approach.

SIL (Squamous Intraepithelial Lesion): This term is used to describe cytological results seen in cells from cytology screening tests. "Squamous" refers to the type of cells covering the cervix. SIL indicates changes in cervical cells but does not diagnose precancer or cancer. To determine the severity and presence of precancer or cancer, a cervical biopsy is necessary.

CIN (Cervical Intraepithelial Neoplasia): This term is used to describe histological findings seen in tissue from cervical biopsy results obtained during a colposcopy examination. CIN describes the degree of abnormal changes in cervical cells and is graded as:

• CIN 1: Mild (low-grade) changes that often resolve on their own without treatment.
• CIN 2: Moderate changes.
• CIN 3: Severe (high-grade) changes.

For further information, you can refer to IARC Screening.