US lab contracted by CervicalCheck to carry out standard screening only - with higher potential for error
HSE did not opt for more advanced screening
The US laboratory which mistakenly gave Vicky Phelan the all-clear said it was contracted by CervicalCheck to only carry out standard screening of smear tests and not a more advanced investigation which has a lower failure rate.
CPL Laboratories in Texas, which controversially won the contract in 2008, operated a two-tier system of smear test readings. Insurance companies in the US have been insisting on a more advanced form of screening for smear tests taken from women in the US.
The regular form of analysis used for Irish women’s smears, which is still being used a decade later, involves liquid-based cytology where the slides are manually interpreted.
However, since 2002 CPL Laboratories has also been using the other testing method for US women which has fewer reading failures and involves also checking the smear for HPV infection, which is strongly linked to cervical cancer.
The Government was advised by Hiqa to bring in this superior HPV test in May 2017, but it has taken the current cancer scandal to lead to a firm promise that it will be introduced later this year.
CPL Laboratories said: “CPL is one of two US and two Irish laboratories that have provided pap smear testing for the Irish cervical screening programme since 2008.
“These screens have been performed through manual examinations of individual slides, without the benefit of computer-based imaging and a separate HPV test, which together comprise the clinical standard in the US and many other countries for cervical cancer screening. This testing was performed to the highest quality standards in order to assure the best possible outcomes for the women participating.
“Despite this, it is internationally recognised that no screening programme is 100pc effective and all have an inherent margin for error.”
A spokeswoman for the HSE was unable to explain yesterday why CervicalCheck did not opt for the more advanced HPV testing at the time it was first outsourced and whether cost was a factor. The HPV tests were approved for the NHS in England after a successful trial in 2016.
The Hiqa examination of the HPV testing in cervical screening said its introduction here would reduce the number of screenings each woman has in her lifetime.
It would also provide better accuracy in detecting pre-cancerous abnormalities and early stage invasive cervical cancer. Women would experience no change in how the cervical screening sample is collected.
Hiqa’s director of Health Technology Assessment and deputy chief executive, Dr Máirín Ryan, said: “HPV infection is associated with almost all cervical pre-cancerous abnormalities and invasive cervical cancers.
“Compared with the current screening strategy, primary HPV screening is a better test which allows all women who participate in cervical screening to become aware of their current HPV status and those who are at higher risk of cervical cancer to be picked up earlier.
“Where a woman is found to be HPV-positive following primary HPV screening, a follow-up test using liquid-based cytology will be carried out on that same sample to inspect for cellular abnormalities. If any abnormalities are detected, a more detailed examination of the cervix is needed.
“Women with a negative HPV test can be reassured they are at very low risk of developing pre-cancerous abnormalities in the next five years.”
CervicalCheck has an age limit of 60 years for screening. But Hiqa said this should be extended up to 65 for women who have only had access to CervicalCheck from age 50. Uptake is lower among older women.