Generic Stuff Flashcards
What is an ImmunoAssay?
An immunoassay (IA) is a biochemical test that measures the presence or concentration of a macromolecule or a small molecule in a solution through the use of an antibody (usually) or an antigen (sometimes). The molecule detected by the immunoassay is often referred to as an “analyte” and is in many cases a protein, although it may be other kinds of molecules, of different sizes and types, as long as the proper antibodies that have the required properties for the assay are developed. Analytes in biological liquids such as serum or urine are frequently measured using immunoassays for medical and research purposes
What are the different ImmunoAssay formats
Immunoassays come in many different formats and variations. Immunoassays may be run in multiple steps with reagents being added and washed away or separated at different points in the assay. Multi-step assays are often called separation immunoassays or heterogeneous immunoassays. Some immunoassays can be carried out simply by mixing the reagents and sample and making a physical measurement. Such assays are called homogeneous immunoassays, or less frequently non-separation immunoassays.
Why is a calibrator used in Immunoassays?
The use of a calibrator is often employed in immunoassays. Calibrators are solutions that are known to contain the analyte in question, and the concentration of that analyte is generally known. Comparison of an assay’s response to a real sample against the assay’s response produced by the calibrators makes it possible to interpret the signal strength in terms of the presence or concentration of analyte in the sample.
What is the principle behind an immunoassay test
Immunoassays rely on the ability of an antibody to recognize and bind a specific macromolecule in what might be a complex mixture of macromolecules. In immunology the particular macromolecule bound by an antibody is referred to as an antigen and the area on an antigen to which the antibody binds is called an epitope.
In some cases, an immunoassay may use an antigen to detect for the presence of antibodies, which recognize that antigen, in a solution. In other words, in some immunoassays, the analyte may be an antibody rather than an antigen.
**In addition to the binding of an antibody to its antigen, the other key feature of all immunoassays is a means to produce a measurable signal in response to the binding. Most, though not all, immunoassays involve chemically linking antibodies or antigens with some kind of detectable label. A large number of labels exist in modern immunoassays, and they allow for detection through different means. Many labels are detectable because they either emit radiation, produce a color change in a solution, fluoresce under light, or can be induced to emit light. **
Immunoassays employ a variety of different labels to allow for detection of antibodies and antigens. Labels are typically chemically linked or conjugated to the desired antibody or antigen.
What is a biobank
A biobank is a type of biorepository that stores biological samples (usually human) for use in research. Biobanks have become an important resource in medical research, supporting many types of contemporary research like genomics and personalized medicine.
Biobanks can give researchers access to data representing a large number of people. Samples in biobanks and the data derived from those samples can often be used by multiple researchers for cross purpose research studies. For example, many diseases are associated with single-nucleotide polymorphisms. Genome-wide association studies using data from tens or hundreds of thousands of individuals can identify these genetic associations as potential disease biomarkers. Many researchers struggled to acquire sufficient samples prior to the advent of biobanks.
Biobanks have provoked questions on privacy, research ethics, and medical ethics. Viewpoints on what constitutes appropriate biobank ethics diverge. However, a consensus has been reached that operating biobanks without establishing carefully considered governing principles and policies could be detrimental to communities that participate in biobank programs.
What are good documentation practices
GDP is the process that is used to demonstrate conformity to the quality system by ensuring records are legible, accurate, identifiable, traceable, valid and permanent.
- Use only current, approved and effective revisions of documents for performing work or recording information
- All handwritten entries, notes, or signatures are to be made with permanent black or blue ball point pen (Post-Its, White-outs or Pencils are not allowed as part of a quality system record
- All Blank spaces (including required but not completed sections of records and logbooks, unused entries spaces, or blank pages) are to be lined out as “N/A” (non-applicable), initialed and dated.
- Back-dating or forward-dating records, entries, data or signature is not acceptable.
- In the event that a date can be read as MM/DD or DD/MM, the month should be spelt out. The preferred dating format for bioMerieux is DDMonYY
- To make a correction, place a single straight line through the error, write the correct information, sign/initial and date the correction. The original record or entry must be legible through the cross-out. When a cross-out is made, if the reason for the cross-out is not clear (such as a minor typographical error), include the reason for the cross-out.
- Multiple corrections on a single page or within a single record by one person may be designated to a single signature and date. An asterisk or similar notation (for example, number with a circle) may also be used when space is not available for explanations or comments on a document.
- When review, verify, or approval signatures are required by a procedure, signatures of approvers shall be accompanied by their functional area, title, or role (whichever is applicable to demonstrate conformity to the procedure). Additionally, it is each employees responsibility to ensure they are trained to a process BEFORE they provide review, verification, or approval signatures. Employees can verify their training by contacting Quality Assurance. If you are asked to approve or verify a record for which you are not trained, please ask your manager to update your training plan.
What contries allow DTC drug advertisements
Only two countries allow Direct-To-Consumer drug advertisements (New Zealand and United States).
Some new drugs sell themselves with impressive safety and efficacy data. For others, well, there are television commercials.
According to a new study, a little over 70 percent of prescription drugs advertised on television were rated as having “low therapeutic value,” meaning they offer little benefit compared with drugs already on the market. The study, appearing in JAMA Open Network, aligns with longstanding skepticism that heavily promoted drugs have high therapeutic value.
“One explanation might be that drugs with substantial therapeutic value are likely to be recognized and prescribed without advertising, so manufacturers have greater incentive to promote drugs of lesser value,” said the authors, which include researchers at Harvard, Yale, and Dartmouth.
What are the main functions of ‘R&D’ and ‘Site Operations’
R&D: Objectives include but not limited to, achieving FDA approval of products, supporting the existing range and developing next generation solutions.
Site Operations: Objectives include but not limited to, manufacturing, supporting the growing demand through manufacturing scalability and securing supply.
What is FDA 501(k)
One of the three approval processes in United States for Medical devices. The other two are ‘Self Registration’ and ‘PreMarket Approval’
Define Medical Device per USA FDA
Medical devices are defined by the US Food and Drug Administration (FDA) as any object or component used in diagnosis, treatment, prevention, or cure of medical conditions or diseases, or affects body structure or function through means other than chemical or metabolic reaction in humans or animals.[2] This includes all medical tools, excluding drugs, ranging from tongue depressors to Computerized Axial Tomography (CAT) scanners to radiology treatments. Because of the wide variety of equipment classified as medical devices, the FDA has no single standard to which a specific device must be manufactured; instead they have created an encompassing guide that all manufacturers must follow. Manufacturers are required to develop comprehensive procedures within the FDA framework in order to produce a specific device to approved safety standards.
What is CCR Title 8 Section 5193
California Code of Regulations Title 8 Section 5193: This legislation exists to minimize the occurence of human disease caused by uncontrolled occupational exposure to blood or other potentially infectious materials (OPICMs).
What is the likelihood of transmission for Hepatitis B, Hepatitis C and HIV
Hepatitis B: 1 in 3
Which out of Hepatitis B/Hepatitis C has no vaccine and no post-exposure treatment
Hepatitis C does not have a vaccine. It causes liver disease.
What to do when a fire breaks out
(from Injury and Illness Prevention Program)
1) Yell ‘Fire’
2) If the fire is small, use a fire extinguisher to put out the fire, but MAKE SURE that your back is to an EXIT
3) If the fire is too big or becomes out of control - immediately exit the program and close the door behind, evacuate building and sound the fire alarm on your way out
Note: use the PASS system to fight fires with fire extinguisher:
- pull the pin
- aim low
- squeeze the level above the handle
- sweep from side to side
What do the difference colors in the NFPA diamonds signify ( as well as the nummbers 0 to 4)
Hazard Communiication Program Posting: NFPA Diamonds
Red: Flammability
Yelllow: Reactivity
Blue: Health
White: Special
0 = No Hazard
1 = Slight Hazard
2 = Minor Hazard
3 = Major Hazard
4 = Severe Hazard
