Tag: hpv

 

IEO Webcast – The value of HPV DNA testing in the fight against cervical cancer

 

“Since the 1970s, screening for cervical cancer has been carried out by cytological examination. In 2012, the Health Technology Assessment report made public the fact that HPV-based screening tests validated as first-line tests could be more effective than cytology-based screening in the prevention of invasive cervical cancer. In 2013, European guidelines, adopted in Italy through the Ministry of Health guidance document, sanctioned the use of HPV testing as the primary test to be used in screening for cervical cancer, which then left cytology to play the role of triage for positive HPV tests. This was because it emerged from the literature data that the sensitivity of the HPV Test was considerably more effective than cervical screening, which nevertheless remains a good triage test because of its high specificity.”-Dr. Fabio Bottari (IEO).

 

To better understand the evolution of HPV diagnosis and screening, the central role of anatomical pathology laboratories, which strategies are now available to health care practitioners in the fight against cervical cancer and how effective they are, we interviewed Dr. Fabio Bottari and Dr. Anna Daniela Iacobone of the European Institute of Oncology (IEO) over the course of 3 episodes.

 

 

 

First Episode – Dr. Fabio Bottari – Available HPV tests and their value to the laboratory

 

 

Second Episode – Dr. Anna Daniela Iacobone – The value of HPV testing in the prevention of cervical cancer, “Value for the Gynaecologist”

 

Third Episode – Dr. Anna Daniela Iacobone & Dr. Fabio Bottari – The added value of SELF-SAMPLING for HPV testing in the prevention of cervical cancer

 

 

 

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The cost of contamination of blood cultures

Contaminated blood cultures (defined as the isolation of a microorganism introduced into the culture during the sampling and/or processing of the specimen and which is not present in the patient's blood at the time of sampling, or otherwise not implicated in the ongoing infection³) can lead to suboptimal patient care and potentially cause a significant increase in costs for hospitals. An article published in 2019 analysed the results of studies that have focused on this topic¹.

Blood cultures are a very important part of the diagnostic pathway because they provide critical information about the presence of bacterial or fungal infections in a patient’s bloodstream. However, contaminated blood cultures can lead to misdiagnosis, inadequate treatment, and additional costs¹. In this article, we will review the results of recent studies on the cost of blood culture contamination and possible interventions to reduce this risk.

 

 

Microbial identification process

If a blood culture is found to be positive, microbial identification of the pathogen and susceptibility testing must be performed to determine the appropriate antimicrobial treatment. However, in the event of contamination, the actual pathogen may be misidentified or even unidentified, leading to misdiagnosis and inadequate treatment.

 

 

Unnecessary antimicrobial treatment

If a blood culture is classified as contaminated, the patient may continue to receive unnecessary antimicrobial treatment, increasing the risk of antimicrobial resistance and adverse reactions to drugs.

 

 

Length of the patient's hospital stay

The length of time that patients with contaminated blood cultures remain in hospital has been found to be up to 5 days longer than that of patients with truly negative blood cultures¹. Another study reported an increase of 2.35 days²in the time spent in hospital due to contaminated blood cultures. This increases the cost of health care and reduces the patient's quality of life.

 

 

Additional total hospital cost

Analysis of all the factors considered in the studies led to the conclusion that the total additional cost to hospitals attributable to contaminated blood culture is between $2,923 and $5,812¹. Taking into consideration direct costs only, those attributable to the additional pharmaceutical and microbiological requirements associated with a false positive blood culture range from $305 to $1,389¹.

 

 

Conclusions

In conclusion, the contamination of blood cultures can lead to additional costs and inadequate care for patients. According to international recommendations⁴, the frequency of contamination of blood cultures should be no higher than 3%. The execution of correct skin antisepsis and sample inoculation procedures are indicated to reduce the risk of introducing the most common contaminants into the culture³.

The results of the studies noted in this article highlight the importance of reducing the risk of contamination by adopting interventions to improve the quality of patient care and blood culture management. These interventions might include:

• greater attention to hand hygiene
• training for health care personnel on the sampling of blood cultures, for example, on:
• the timing of the sampling
• the volume of blood collected
• the transport of vials to the Microbiology laboratory³
• the implementation of infection prevention protocols
• the use of advanced technologies for the sampling and analysis of blood cultures¹.

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References

1. Dempsey C, Skoglund E, Muldrew KL, Garey KW. Economic health care costs of blood culture contamination: A systematic review. Am J Infect Control. 2019;47(8):963-967.2.
2. Lalezari A, Cohen MJ, Svinik O, et al. A simplified blood culture sampling protocol for reducing contamination and costs: a randomized controlled trial. Clin Microbiol Infect. 2020;26(4):470-474.
3. CLSI. Principles and procedures for blood cultures; Approved Guidelines. CLSI document M47-A. Wayne, PA: Clinical and Laboratory Standards Institute, 2007.
4. Baron Ej, Miller JM, Weinstein MP et al. A guide to utilization of the microbiology laboratory for diagnosis of infectious diseases: 2013 recommendations by the Infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM)(a). Clin Infect Dis 2013;57:e22-2121

 

 

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Vaginal swabs with a self-sampling procedure for HPV DNA testing in the prevention of cervical cancer

In 2020 the World Health Organization (WHO) launched a plan of action to achieve the elimination of cervical cancer caused by Human Papilloma Virus (HPV) through the vaccination and treatment of at least 90% of women by 2030¹.

Much had already been done before the pandemic, through awareness campaigns on the fundamental issue of prevention¹-².

 

Italy has locally organised screening programmes, which for decades have provided free access to cervical screening/HPV DNA testing for women of 25 to 64 years of age, bringing the incidence of cancer to lower levels than the world average. However, the incidence is not yet at zero, and it is therefore important to maintain high levels of vigilance and to continually improve access and adherence to preventive tests³. As attested by the IARC since 1996, HPV infection is the essential condition for the development of cervical cancer: it is the first cancer to be recognised by the World Health Organisation as being totally attributable to infection. This was discovered in 1976 by Prof. Harald Zur Hausen, who was awarded the Nobel Prize 30 years later, in 2008.

 

There are approximately 120 types of HPV viruses, but only 12 cause cervical cancer. Testing positive for HPV does not necessarily mean you have cancer at that time, but it does mean you are at greater risk of it developing in the future. Most of these infections resolve spontaneously with no symptoms, but an infection that persists for more than two years can result in precancerous lesions and carcinoma⁴. In 2020, cervical cancer was the fifth most common cancer in women in Italy under 50 years of age(2,400 new cases estimated in 2020, accounting for 1.3% of all cancers affecting the female population⁵.

 

Eliminating cervical cancer is now a global public health goal launched by the WHO in 2018, and a commitment of the European Union, which has included it in Europe's Beating Cancer Plan⁶. The aim of screening for cervical carcinoma is to detect persistent infections caused by types of viruses that have oncogenic potential, and para-neoplastic lesions, in order to implement appropriate follow-up and treatment before an actual tumour develops³.

 

Nowadays, it is no longer necessary to see a gynaecologist for HPV testing. Patients can also choose to collect a sample themselves at home and take it to a licensed diagnostic centre, where they will get a clear result quickly in the interests of staying healthy. All under the supervision of a practitioner who will manage follow-up for the woman in the event of a positive result. HPV DNA testing is simple and effective, and women can also collect samples independently thanks to self-sampling procedures using suitable validated⁷-⁸ devices. With self-sampling, which is already practised when screening to prevent colorectal cancer for example, women can collect a sample of cells for HPV DNA testing themselves at home, without having to go to a clinic or gynaecologist, making it even easier to participate in the screening campaign. A number of clinical studies⁹ have been carried out to assess the reliability and accuracy of the results obtained by self-sampling, and both women and practitioners can trust the procedure.

 

To screen for HPV infection, Becton Dickinson offers BD Onclarity™ HPV test, which is performed in the laboratory on BD Viper™ LT (for small- to medium-sized laboratories) and BD COR™ (for high productivity centralised laboratories) automated platforms. The test fully complies with the European Regulation, being CE IVD marked, and is clinically validated according to the Meijer¹⁰ criteria for applicability in cervical screening using the primary HPV DNA test. The test is CE-IVD validated on specimens collected to additionally perform liquid cytology (cervical screening test) in BD SurePath™ or ThinPrep® vials.

 

BD Onclarity™ HPV test makes it possible to:

● detect the DNA of the 14 HPV genotypes that carry oncogenic risk (HR- HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) associated with the development of cervical cancer, with the possibility of extended genotyping in addition to HPV genotypes 16 and 18. Six genotypes are genotyped individually, and the remaining are genotyped into 3 different groups (P1, P2 and P3)

● analyse the genes for viral oncoproteins E6 and E7, reducing the risk of false negative results that can be found with DNA analysis in the L1 gene, following the integration of viral DNA into cellular DNA

● reduce false positive results due to cross-reactivity with HPV genotypes with low oncogenic risk

● ensure the detection of possible co-infection by the 14 different genotypes with high oncogenic risk

 

 

MUSA™ – Be inspired by simplicity

Out of these assumptions, and the desire of BD to become a pioneer and at the forefront working alongside Italian laboratories and women in supporting women's health and screening against HPV, MUSA™, an initiative created to raise awareness of the importance of cervical cancer prevention through the diagnosis of Human Papillomavirus, has emerged.

 

In close collaboration with the Italian Diagnostic Center – CDI, MUSA™ promotes the importance of screening as an indispensable weapon with which to fight this disease, thanks also to the innovative HPV Test in self-sampling mode: convenient, easy and effective, which can be used wherever and whenever the patient wishes. By filling in a simple request form, patients can purchase the self-sampling kit, which will be delivered to their home. This enables them to collect a sample for the HPV test independently and send it to the Laboratory by post/courier. This method of sampling was designed to try to maximise and facilitate participation in screening programmes for women who find it difficult or embarrassing to attend a clinic¹¹-¹².

 

In recent years, clinical studies conducted both in Italy and internationally have sought to determine both the satisfaction of self-collection and the safety and efficacy of the HPV DNA test performed on self-collected samples compared with those collected by a practitioner (gynaecologist/obstetrician). The results confirmed thereliability of self-sampling and a high level of acceptance among women ¹¹-¹².

 

Do you want to find out more? Click on the banner below and follow MUSA™ on Instagram and Facebook.

 

 

 

 

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References

 

1. Global strategy to accelerate the elimination of cervical cancer as a public health probmem. OMS 2020
2. European guidelines for quality assurance in cervical cancer screening. 2015
3. Camara H, Zhang Y, Lafferty L, Vallely AJ, Guy R, Kelly-Hanku A. Self-collection for HPV-based cervical screening: a qualitative evidence meta-synthesis. BMC Public Health. 2021 Aug 4;21(1):1503.
4. Gisci website. https://www.gisci.it/il-nuovo-programma-di-screening-con-il-test-hpv-sostituisce-il-pap-test. Visited 27 February 2022
5. Redazione ANSA. https://www.ansa.it/canale_saluteebenessere/notizie/sanita/2022/05/31/hpv-in-italia-quinto-tumore-per-le-donne-under50_364100ce-cd7c-4410-9ca2-e4190785e0da.html Visitato il 01 giugno 2022
6. Europe’s Beating Cancer Plan
7. Rossi P, Marsili LM, Camilloni L, Iossa A, Lattanzi A, Sani C, Di Pierro C, Grazzini G, Angeloni C, Capparucci P, Pellegrini A, Schiboni ML, Sperati A, Confortini M, Bellanova C, D’Addetta A, Mania E, Visioli CB, Sereno E, Carozzi F. The effect of self-sampled HPV testing on participation to cervical canrcer screening in Italy: a randomised controlled trial (ISRCTN96071600). British Journal of Cancer (2011) 104, 248 – 254.
8. Snijders P, Verhoef V, Arbyn M, Ogilvie G, Minozzi S, Banzi R, van Kemenade F, Heideman D, Meijer C. High-risk HPV testing on self-sampled versus clinician-collected specimens: A review on the clinical accuracy and impact on population attendance in cervical cancer screening. International Journal of Cancer (2013) 132(10):2223-36
9. Canfell K, Smith MA, Bateson DJ. Self-collection for HPV screening: a game changer in the elimination of cervical cancer. Med J Aust. 2021 Oct 18;215(8):347-348.
10. BD Onclarity™ HPV Assay EU Package Insert (8089899).
11. Del Mistro A, et al. Efficacy of self-sampling in promoting participation to cervical cancer screening also in subsequent round. Prev Med Rep . 2016 Dec 23;5:166-168. doi: 10.1016/j.pmedr.2016.12.017. eCollection 2017 Mar
12. Arbyn M et al. Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses. BMJ. 2018 Dec 5;363:k4823. doi: 10.1136/bmj.k4823.

 

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