Hybrid Capture 2 Technology

Hybrid Capture 2 (hc2) technology serves as the platform for QIAGEN’s nucleic acid hybridization assay for detection of human papillomavirus (HPV), Chlamydia trachomatis (CT), and Neisseria gonorrhoea (GC). This diagnostic method allows rapid, standardized testing of genetic material of the infectious agents in virtually any laboratory setting. It employs specific RNA probes, hybridization, antibody capture, and signal amplification that utilizes qualitative chemiluminescent detection.


The digene HPV Test, using Hybrid Capture 2 technology, provides an accurate, cost-effective, user-friendly method by achieving reliable detection without the need for dedicated and isolated lab space, sophisticated laboratory expertise, or concern related to inhibition and contamination.
Benefits of Hybrid Capture:

* Same-day, objective results using a micro-plate test format
* High-throughput automation for handling increasing test volumes
* Minimal required specimen preparation allowing samples to be processed quickly and efficiently
* Less complex workflow than target amplification methods
* Reduced risk of cross-over contamination due to signal amplification instead of target amplification
* Extensive clinical validation data available

hc2 technology superior to PCR methods for HPV DNA testing

For routine HPV diagnostics, it is essential to have a test system at hand which reports clinically relevant results and, hence, can impact clinical decision-making. In contrast to the detection of other infectious disease parameters, a high clinical sensitivity is critical for reliable HPV diagnostics. The hc2 technology fulfills this requirement better than any other method as outlined in multiple clinical validation studies.

In contrast, a high analytical sensitvity as provided by nucleic acid amplification technologies such as PCR is counterproductive for HPV diagnostics as they may detect many transient HPV infections of clinical insignificance. Cervical cancer screening methods require HPV detection correlating to disease and not to the sheer presence of the virus, since 90% of infections is cleared by itself without consequences.

hc2 technology measures sensitivity versus defined clinical endpoints (CIN 3+/SCC) and ensures reporting of positive results only when risk of disease progression exists. QIAGEN’s digene HPV Test has an excellent clinical sensitivity of up to 100% in primary adjunctive screening when combined with a Pap smear test.

* Clinically validated cut-off of 5000 copies/ml
* Proven in extensive multiple trials
* Ensures high negative predictive value

PCR screening can miss severe disease


PCR methods show a high analytical sensitivity with detection limits between 10-400 copies of HPV DNA resulting in detection of clinically irrelevant viral levels as such infections can be cleared off by immune response. Due to viral integration and loss of the targeted regions (L1, E1, E2) or mutation, PCR can miss cases of severe precancer and cancer cases.

* Risk of missing cases of cancer
* Detection of clinically irrelevant viral levels


Hybrid capture (hc2) versus PCR — analytical sensitivity and clinical sensitivity. The analytical sensitivity of hc2 has been adjusted to 5,000 copies of HPV DNA, and the analytical sensitivity of PCR methods can be <10 copies of HPV DNA.
How Hybrid Capture 2 Technology works

The Hybrid Capture 2 System is a signal-amplification assay that uses a technique combining antibody capture and chemiluminescent signal detection. The basic steps of the Hybrid Capture 2 assay are outlined below:

Basic Steps

Clinical specimens are prepared by adding a base solution, which disrupts the virus or bacteria and releases target DNA. Presence or absence of target DNA is read from the results of the chemiluminescent reaction.

Hybridize RNA probe with target DNA Hybrid Capture Signal Amplification

Fig 1: Hybridize RNA probe with target DNA. Target DNA combines with specific RNA probes, creating RNA:DNA hybrids


Fig. 2: Hybrid Capture. RNA:DNA hybrids are captured onto a solid phase coated with universal capture antibodies specific for RNA:DNA hybrids.


Fig. 3: Signal Amplification. Capture RNA:DNA hybrids are detected with multiple antibodies conjugated to alkaline phosphatase. The signal resulting from the chemiluminescent reaction is read and results interpreted.

Doctors call for cancer screens

DUBAI // Doctors have called for a national cervical cancer vaccination and screening programme to catch cases earlier and reduce the rate of the second most common cancer found in women, one that has seen progressively higher incidence in the UAE.

Cervical cancer affects 9.9 women in every 100,000, according to figures by Health Authority Abu Dhabi (HAAD), almost twice the incidence in the broader Middle East, which amounts to nearly five in every 100,000.

It afflicts women at a rate second only to breast cancer, but 70 per cent of cases are diagnosed in the late stages. At that point, only one in three women has a chance of survival. There is no co-ordinated screening programme for cervical cancer in the UAE, as there is in countries where most cases are detected in the early stages.

Dr Saad Aswad is a senior consultant gynaecologist and oncologist – the only specialist of his kind in the UAE – at Tawam Hospital in Al Ain. He compiled a detailed report on a proposed screening programme for cervical cancer drawing on the expertise of more than 40 health professionals and forwarded it to the Ministry of Health in 2004. There has still been no move to implement any of the plans. MoH officials were not available yesterday to comment.

“We need to do something to protect the women,” Dr Aswad said. “Cervical cancer is a cancer we can prevent. Why are we not doing this across the country? If the Ministry of Health introduced it, I think everyone would follow.”

While schoolgirls in Abu Dhabi are offered the Gardasil vaccination for up to Dh50 (US$13.60) for the required three doses, it can cost up to Dh1,900 in Dubai and is not as widely available in other emirates.

Dr Aswad said the preventive vaccine should be available across the whole country.

“We must push for this to be nationwide. It is much easier to implement prevention than cure.”

HAAD said in April it planned to build on a successful pilot vaccination programme in schools and make the vaccine available to all schools in the Emirates.

Last year it vaccinated around 6,000 girls aged 17 and has given another 4,000 the first dose this year. There was a 70 per cent uptake during the pilot scheme. Dr Mawahib al Biate, head of the gynaecology department at the GMC Hospital in Ajman, said a national vaccination programme was needed in the UAE.

“Prevention is always better than the cure,” she said. “A national programme would be a very good idea because of the rates here.” She also said it did not make sense for such an important vaccine to be offered cheaply to some but not others.

In 1998 the MoH reported only eight diagnosed cases of cervical cancer in the country. Last year Tawam Hospital alone saw at least 100 cases, Dr Aswad said.

Recent studies into the efficacy of Gardasil, which was approved by the US Food and Drug Administration in 2006, showed it was effective against the human papillomavirus (HPV) type 16 for an average of eight and a half years. The women in the study, by the University of Washington in the US, were vaccinated in 2001, so more follow-up tests are needed to establish the length of protection. HPV 16 and 18 cause 70 per cent of cervical cancer cases worldwide. Gardasil, made by Merck, is licensed in 109 countries, but some of them find it more difficult to implement a vaccination programme, Dr Aswad said.

Health officials estimate one in 10 women will get an HPV infection in their lifetime, but it is more common in women under 30. Some strains are sexually transmitted, and questions have been asked in some countries about the moral issue of vaccinating young girls.

“Here cervical cancer is increasing out of proportion with the population growth,” Dr Aswad said. “It is time to start protecting the women.”

Dr Ibrahim Abd Elrahman, a consultant gynaecologist and obstetrician at The City Hospital in Dubai, applauded any effort to introduce a national vaccination programme. He saw many women who had never had a Pap smear. “Often I get someone in their late 20s or early 30s who say they have never had one. I organise one with their consent.”

Mitya Underwood

* Last Updated: May 14. 2009 12:14AM UAE / May 13. 2009 8:14PM GMT

Cervical cancer strikes younger women in UAE

By Nina Muslim, Staff Reporter
Published: May 14, 2009, 10:30
http://archive.gulfnews.com/nation/Health/10313458.html

Dubai: Women in the UAE are dying at a younger age from cervical cancer, about ten years younger than the world average of 49, prompting doctors to call for better awareness and prevention.

Dr Sa'ad Gazzal Aswad, head of obstetrics and gynecology at Tawam Hospital said at a press conference on Wednesday that he was seeing more and more women between the age of 35 and 40, instead of 50 a decade ago.

"I don't know why; we will have to study more. But the point is that it affects young women of childbearing age with children, leaving (the children) when they die," he told Gulf News later.

"The impact is really sad. I had a 32-year old patient who died and she had nine children, the youngest is 2. The cancer affects not just the person but the whole family," he said.

He added the patient, like more than 70 per cent of all cases he has been receiving, was referred to him when her cancer was already considered advanced and had a lower rate of survival. According to Tawam Hospital records, about 100 cases of cervical cancer were recorded last year.

Furthermore, more women in their 20s were presenting with abnormal pap smears, or pre-cancerous lesions.

Cervical cancer is caused by strains 16 and 18 of the Human Papilloma Virus (HPV), which is the same virus (but different strain) that causes genital warts. It is transmitted through sexual contact, which does not necessarily involve sexual intercourse. There are two vaccines available to prevent the cancer, but only one is approved by the US Food and Drug Administration.

Dr Wissam Haddadin, franchise manager of the cervical cancer vaccine Gardasil, produced by Merck, Sharpe and Dohme, said more awareness and prevention were needed to stop the preventable disease from striking women down.

"Some people don't realise (in cervical cancer's case) there is a causative agent," she said.

She added prevention and awareness in the region was very low, saying a 2006 informal survey the company conducted found about 20 per cent of women questioned knew what a pap smear was and only 9 per cent did it.

Pap smear is a screening procedure, in which a cell scraping is taken from the cervix and examined for pre-cancerous lesions.

Some screening programmes are taking place, including at primary healthcare centres under the Ministry of Health. Private medical centres also offer the service. However, there is no comprehensive and uniform policy in place to ensure all women in the UAE are being screened for the cancer.

Do you have regular checkups? Do people avoid being checked for fear of having an illness? Do you know of anyone who had successfully battled cancer due to early detection?
Your comments

The article has definitely created awareness about cervical cancer. More information regarding symptoms, causes and cures would help readers understand the disease better. Also at what age must a woman get herself tested and details could help women to have regular checkups. Generally people avoid checkups either because they are very busy in their family life, they feel fit or they have a fear of having an illness. Women (especially working women) lead a hectic life and have no time for themselves. My cousin?s wife (age 37) was diagnosed with breast cancer last year. She underwent mastectomy and then chemotherapy and radiation and now is leading an almost normal life. She feels weak at times and does not have the energy she had before the illness. Cancer is a killer disease and fighting it is possible if detected in the early stages. Awareness about the disease and its various forms must be spread so that people will not hesitate to go for required tests. Regular exercise and a healthy diet could ward off most diseases. A regular checkup even if a person is perfectly fine and healthy is necessary.
Naina Nair
Sharjah,UAE
Posted: May 14, 2009, 17:23

Doctors should advise the women to do this Pap smear test and should encourage them to do it, there is no harm if the doctor will tell his patient to do this check up test, I told my wife to do a full check up and they didn't even tell her about this test.
Samer K.
Dubai,UAE
Posted: May 14, 2009, 17:20

I had been experiencing abnormalities in my menstrual cycle. When I came to Dubai, I decided to visit an OB/Gynaecologist for a check up. I found out that a year after giving birth, I must have a pap test and also that the doctor discovered some infection. And she told me that if I had taken long to seek doctor's advice, it could lead to cervical cancer. So, that is when I realised that a single infection that I didn't mind for a long time could worsen my health. So, now, I do my pap test every year to check the condition of my cervix. It is good for women to be aware and please do not be ashamed of this kind of situation. Doctors are here to understand us and to help us prevent the sickness. Always remember that Prevention is better that CURE.
Mhadzie
Dubai,UAE
Posted: May 14, 2009, 11:44

I am a mother and know how preoccupied my lot is with looking after our young children and families. Most mothers are so busy attending to the needs of the rest of the family members that they hardly have ANY time left for themselves. This lack of time for oneself often does take quite a toll on the mothers. I sincerely appreciate such eye-opening articles by Gulf News. Please continue the good work.
Shiuli Dutt Dey
Dubai,UAE
Posted: May 14, 2009, 11:43

the issue is that most of these tests are not even covered by insurance so unfortunatly people think about the financial aspect. Insurance should cover one test on a regular basis, this would also save them money when curing at an early stage instead of big expenses at a late stage.
From A Reader
Abu Dhabi,UAE
Posted: May 14, 2009, 11:00

There definitely should be more awareness about Cervical cancer, since it is becoming very common among women at a very early age.The worst thing about this cancer is that it is diagnosed at 3rd or 4th stage and it becomes too late to save the patient then. I would like to urge every woman to educate themselves by reading about cervical cancer and to take precautionary measures in advance. Also, it is important to spread the awareness about the disease among my friends and family. Being 23 years old, I would like to get preventive vaccination for the same. I would like to know about hospitals and clinics which would conduct the necessary test. I think the authorities should take measures to spread the awareness among women. Many people haven't even heard about this disease.
Zahrah
Dubai,UAE

How do I talk to my partner about HPV?

You and your partner may benefit from talking openly about HPV. You can tell your partner that:

* HPV is very common. It can infect the genital areas of both men and women. It usually has no signs or symptoms and goes away on its own.
* Most sexually active people get HPV at some time in their lives, though most will never know it. Even people with only one lifetime sex partner can get HPV, if their partner had it.
* There is no test yet for men to find out if they have HPV. But the most common health problem caused by HPV in men is genital warts. The type of HPV found on your HPV test can cause cervical cancer in women; it does not cause genital warts.
* Partners who have been together for a while tend to share HPV. This means that your partner likely has HPV already, even though your partner may have no signs or symptoms.
* Having HPV does not mean that you or your partner is having sex outside of your relationship. There is no sure way to know when you got HPV or who gave it to you. A person can have HPV for many years before it is found.

If your sex partner is female, you should talk to her about the link between HPV and cervical cancer, and encourage her to get a Pap test to screen for cervical cancer.
Common Questions about HPV
Is there a treatment for HPV or abnormal cells?

There is no treatment for HPV (a virus). But there are treatments for abnormal cervical cells, which can be killed or removed. Treating abnormal cells will stop them from growing into cancer. But it may not remove the virus (HPV). That’s why it’s important to go back to your doctor as told, to make sure abnormal cells do not grow back. You may need to get Pap tests more often for a while. But most people do eventually fight the virus off.
Does having HPV or abnormal cervical cells affect my chances of getting pregnant or having healthy babies?

Having HPV or cell changes on your cervix does not make it harder to get or stay pregnant. The type of HPV that is linked to cancer should not affect the health of your future babies. But if you need treatment for your cell changes, the treatment could affect your chance of having babies, in rare cases. If you need treatment, ask your doctor if the treatment can affect your ability to get pregnant or have a normal delivery.
couple Will I pass HPV to my current partner?

If you have been with your partner for a while, your partner likely has HPV too. But your partner likely has no signs or symptoms of HPV. Partners usually share HPV, until your bodies fight it off naturally. There is no way to know if your partner gave you HPV, or if you gave HPV to your partner.
Can I prevent passing HPV to a new partner?

Condoms may lower your chances of passing HPV to your new partner, if used all the time and the right way. But HPV can infect areas that are not covered by a condom—so condoms may not fully protect against HPV. The only sure way to prevent passing HPV to a new partner is to not have sex.

Ministry of Health UAE cancer awareness seminar

Over 100 doctors from the Ministry of Health (MOH) attended a Continuous Medical Education Seminar (CME) held under the patronage H.E Dr. Mariam Matar, Assistant Undersecretary of Preventive Medicine in the Ministry of Health (MOH) for Public Health and Primary Health Care (PHC).

Saturday, April 28 - 2007

The aim of the session titled 'Screening for Female Health' took place this morning at Al Baraha Hospital to raise awareness of prevention and early detection of breast and cervical cancer - the two most common forms of cancer to affect women worldwide.

'The CME sessions conducted are crucial for updating the skills of the Primary Health Care (PHC) doctors;' says Dr. Mariam Matar, Assistant Undersecretary of Ministry of Health (MOH) 'The Public Health and PHC sector is developing central CME programs which include lectures, workshop and research training. This program will enhance and improve the quality of PHC services across the UAE.'

'This activity comes as part of the Ministry of Healths' ongoing efforts to update Primary Health Physicians on the latest oncological advances,' says Dr. Muna Al Kawari, Project Director for Women's Health in Public & Primary Health Care, Ministry of Health.

'Breast and cervical cancer are the leading causes of death in women around the world. Through these sessions, our doctors will encourage women in the UAE to implement regular screenings to prevent and detect cancer before it's too late.'

Breast cancer is the most common type of cancer among women worldwide. As many as eight to nine percent of women will develop breast cancer at some point during their lifetime and more than 1.2 million women will develop it this year.
As with most diseases, fear and lack of knowledge are major contributors to delayed detection of breast cancer.

'The fact is that although breast cancer may be life threatening, research has shown that early detection significantly increases the chances of survival,' explained Dr. Mona Sabelgi, Screening Coordinator, Central Ministry of Health Department, Abu Dhabi. 'I urge for all women over the age of forty in the UAE to have a mammography test.'

Cervical cancer is the second most common cancer and cause of death in women worldwide. In the UAE it is on the rise with reported cases tripling in 2005. Worldwide there are an estimated 650 deaths, which is the equivalent of 10 women in the Middle East dying every day.
'Cervical cancer is caused by a virus called the Human Papilloma Virus (HPV). This virus is very common and easily transmitted, but thankfully not all females infected with HPV will have cervical cancer,' says Dr. Saad Aswad, Consultant Gynaecologist Oncologist in Tawam Hospital, and Associate Professor of Gynaecology, at the UAE University.

'The virus once contracted, can survive for years and eventually converts some cells on the surface of the cervix into cancer cells. By killing the virus you eliminate the chance of contracting cervical cancer. Prevention of infection is imperative for all women; this can be done in two ways, regular pap screening tests and being vaccinated against it.'

These seminars on early detection and prevention of cancer highlight the Ministry of Health's commitment to encouraging women in the UAE to having regular screenings.

Diagnosis and Treatment for Cervical Cancer

The key to protecting yourself from cervical cancer is early diagnosis and treatment. When caught early, nearly all cervical cancers are treatable. And the surest way to catch cervical cancer early is to get regular pap tests, and HPV tests when recommended.
Learn more about pap testing
If you have abnormal pap test results

If your pap test shows abnormal cells, your doctor will discuss appropriate follow-up. In some cases, your doctor may simply recommend pap testing at more frequent intervals. In other cases, your doctor may suggest colposcopy, a procedure that enables the doctor to examine the cervix — the lower, narrow portion of the uterus that joins with the vaginal canal — under magnification. If necessary, a biopsy, in which a small tissue sample is taken, may be performed.
Learn more about what abnormal test results mean
Treating cervical cancer1

Cervical cancer is a highly treatable condition. The choice of treatment is a decision made between a woman and her doctor, considering a number of factors such as the stage of cancer and the desire for future pregnancy. The treatment options for cervical cancer include surgery, radiation, and chemotherapy, given alone or in combination.

Surgical treatments allow for the removal of precancerous or cancerous cells; common procedures include:

* LEEP — loop electrosurgical excision procedure (LEEP) uses electrical current passed through a thin loop-shaped wire to remove precancerous cells on the surface of the cervix.
* Conization — also called a cone biopsy, this procedure involves the removal of a cone-shaped piece of tissue from the cervix.
* Hysterectomy — is the removal of all or part of the uterus and cervix, and can be performed via an incision in the abdomen or the vagina.

Nonsurgical treatments can include:

* Radiation therapy — uses high-energy X-rays or other radiation to kill or prevent cancer cells from growing. It can be given either from the outside (much as you would receive an X-ray) or from the inside (using various kinds of radioactive seeds, wires, or catheters).
* Chemotherapy — uses one or more drugs to kill cancer cells or stop them from growing.

You can learn more about cervical cancer treatment options on the National Cancer Institute (NCI) website.

After treatment ends, it is important to follow up with routine checkups and pap tests to ensure that the cancer doesn’t return. This is especially true for the first few years after treatment.


Reference

1. American College of Obstetricians and Gynecologists Pamphlet. Cancer of the Cervix. Washington DC; 2004.
Confused by Your Pap Test Results?

Learn more about the language commonly used to describe pap test results.
What Does an Abnormal Pap Test Result Mean?

Find out how abnormal pap test results may affect your health.

Princess opens new women’s clinic

April 14. 2009 8:30AM UAE / April 14. 2009 4:30AM GMT
DUBAI // A major gynaecology centre was opened yesterday as doctors said women were finally catching on to the need for cervical cancer screening and vaccination.

The Dubai Gynaecology and Fertility Centre was officially opened by Princess Haya bint Al Hussein, wife of Sheikh Mohammed bin Rashid, Vice President of the UAE and Ruler of Dubai.

There has been recent attention on cervical cancer after the British reality television star Jade Goody died of the disease aged 27.

Her death last month made headlines around the world.

Dr Awatif al Bahar, consultant obstetrician and gynaecologist at the new centre, said at the opening ceremony: “Cervical cancer is increasing here but so is awareness at a social level.

“We have been doing repeated lectures for women, being very honest with them about this cancer. This has made more women come forward to screening and vaccinations.

“Things are definitely improving and we, as doctors, are always pushing women to take care of themselves.”

The clinic, which has relocated from near Rashid Hospital because of increased demand, is one of the leading centres in the Gulf for infertility treatments.

“We discuss what they should do if they are sexually active and encourage all women to be screened,” Dr al Bahar said. “Women here want a better quality of life. That does not mean having nice dresses and perfumes, it means being healthy.”

Cervical cancer is the second most common cancer affecting women in the UAE and 70 per cent of cases are diagnosed in the late stages.

Vaccines against the human papillomavirus (HPV), which causes the cancer, have been approved by all health authorities in the Emirates and uptake has improved dramatically in recent years.

Dr Sabina Aidarous, a family medicine specialist at the Imperial Healthcare Institute in Dubai Healthcare City, said that over the past three years there had been an increase of up to 70 per cent in women having “well woman” check-ups, which include cervical cancer and breast cancer screening.

There had also been an increase of 20-30 per cent of women having the HPV vaccine since last year.

“Although women in general are becoming a lot more aware, there are still some who are less educated about what they need to do,” she said. “We hope in the future to reach a stage where vaccines against cervical cancer is routine.”

One of the main stumbling blocks in the region is the cancer’s connection to sexual activity.

Dr Aidarous said most people now realised that HPV was sexually transmitted, making it a “contentious issue in this part of the world”.

“It will take time and a lot of campaigning and awareness. But the situation is certainly getting better.

“Younger women are more clued up but it is the older generation who are less so. There are women in their 50s who have never had a smear test because they think they are low risk.”

She also explained that a common misconception about cervical cancer was that having just one monogamous relationship left little to no chance of developing it.

“Being married to one partner doesn’t mean you are exempt from this,” she said. “For a long time there was nobody who would talk about cervical cancer, but now this is totally changing.”

Dr Aidarous is set to launch a campaign with GlaxoSmithKline, the maker of the HPV vaccine Cervarix.

This campaign will be one of the a number to raise awareness of the disease, which the World Health Organisation estimates kills around 250,000 women a year worldwide.

In July, the Ministry of Health launched the Emirates Cervicare Network (ECN) to encourage women of all ages to go for an annual Pap smear test and young girls to be vaccinated against the virus.

Earlier this year the ECN and the Dubai Roads and Transport Authority organised a bus offering advice about cervical cancer to tour Dubai for two weeks.

Last week the Health Authority – Abu Dhabi said its HPV vaccination campaign for teenagers had seen a 70 per cent uptake in 2008. The programme will now be made permanent.

“If someone has an early marriage, maybe 17, 18 or 19 years old” Dr al Bahar said, “and does not come in for a women’s health check-up until they are 30, they have already been sexually active for a long time.

“Women are definitely learning, it will just take time.”

Cervical cancer is often referred to as a “silent killer”, as it grows slowly over many years and is largely without symptoms.

Without regular screening it may not be detected until the later stages. Official figures show women have a one in three chance of surviving.

Tawam Hospital in Al Ain is currently devising an executive health programme with an emphasis on preventative medicine.

Dr Halah Ibrahim, consultant in internal medicine, said one of the aims is to try and encourage women to overcome any reluctance they might have about health issues considered taboo. We have already been doing a lot of education in the community about the importance of screening. Cervical cancer is so common here there has to be a push to do more Pap smears.”