Vitamin D

 

 

 

 

 

 

 

Article Critique on Method evaluation study of a new generation of vitamin D essays.

Write a critical review of the article: Enko D, Kriegshauser G, Stolba R, et al. Method evaluation study of a new
generation of vitamin D assays. Biochemia Medica.(2015) 25(2): pp. 203-12. . Note the following: The
reference range for vitamin D is approximately 10-65 ng/mL. CLIA has no TEa for vitamin D measurements. It
can be taken as 3x the method’s standard deviation, a general practice for immunoassays; however, we do not
know the standard deviation for these methods. A study by Stocki et al. has been used by other studies to
evaluate SEa and REa of total vitamin D assays. These authors use a 5% limit for bias and a 10% limit for CV.
Use this benchmark to determine total error allowable for vitamin D assays. Source: Stocki D, Sluss PM,
Thierpont LM. Specifications for trueness and precision of a reference measurement system for serum/plasma
25-hydroxyvitamin D analysis. Clin Chem Acta. (2009)408: pp 8-13.
Your critique must answer the following questions:
1. Keeping in mind that this study was not meant to be either a validation or verification of manufacturer’s
claims what is missing from this study?
2. Was 3-epi-25-hydroxy vitamin D a confounder in this study?
3. Were sample collection and processing appropriate?
4. The authors conclude that precision of all four assays is acceptable because within run and between run
precision were each below 20%. Are there any concerns with their precision study benchmarks and
interpretation?
5. The authors conclude that the new IDS-iSYS and ORGENTEC 25(OH)D assays are suitable for measuring
total vitamin D in clinical laboratories. Would you adopt the ORGENTEC 25(OH)D assay for your laboratory?
Explain why or why not.
6. Do you agree that this study shows that lack of standardization is the solution to solving the interassay bias
problem seen with 25(OH)D assays? Why or why not

 

 

Sample Solution

Protection Act (1984, 1998) The main purpose of this Act is to protect personal data stored on computers or in an organised paper filing system. The Act applies to both manual and computerised personal files and requires transparency in the use of information and emphasises the need for privacy and access by individuals (data protection, 2018). The Data Protection Act 1984 has now been replaced by the Data Protection Act 1998.The Act applies to both manual and modernized individual records and requires straightforwardness in the use of data and underscores the requirement for security and access by people. (data protection, 2018). The Data Protection Act 1984 has now been supplanted by the Data Protection Act 1998 and its basic role of current information assurance enactment is to ensure people against conceivable abuse of data about them held by others. Under the terms of the new Act, processing of data includes any activity to do with the data involved. All staff who approach or utilise individual information like: address records, contact points of interest and additionally singular documents need to guarantee that such information isn’t revealed to any unapproved individual, on account of delicate individual information which incorporates information about: racial or ethnic details, political convictions, religious or different beliefs, exchange association participation, wellbeing, sexual orientation, criminal charges and procedures or feelings there are extra confinements and express consent will typically be required. (data protection, 2018) Under the terms of the new Act, handling of information incorporates any movement to do with the information included “and its primary purpose of current data protection legislation is to protect individuals against possible misuse of information about them held by others”. (data protection, 2018) Disability Discrimination Act (1995, 2005) Equality Act (2010) The Act was the pinnacle of public campaign to constrain the government to end state and business discrimination against disabled people,” is an important piece of legislation with the potential to protect the employment rights of people with disabilities. It covers people with physical or mental impairments that have a substantial and long-term adverse effect on their ability to carry out normal day-to-day activities”. (Boardman, 2018) The Act was amended in 2005 and made significant changes to the 1995 Act. The Disability Discrimination Act (DDA) is a civil right law who establish to make discrimination against disabled persons (people with cancer, HIV infection, multiple sclerosis, severe disfigurement or blind) sex discrimination, race relation in connection with employment or provision of goods, facilities and services or management disposal illegal, buying or renting a property,” it is unlawful to discriminate against people in respect of their disabilities in relation to employment, the provision of goods and services, education and transport”. (legislation.gov.uk, 2018) In 2010 Equality Act was establish to replaced previous anti-discrimination laws (Disability Discrimination, Race Relations, Sex Discrimination) with a single Act, and legitimately shields individuals from discriminat

This question has been answered.

Get Answer
WeCreativez WhatsApp Support
Our customer support team is here to answer your questions. Ask us anything!
👋 Hi, Welcome to Compliant Papers.