LECTURE 2 Flashcards
What is believed to be the earliest diagnostic test, dating back to 1500 BC?
Urine testing for diabetes.
By the 1600s, how was diabetes diagnosed?
Tasting urine.
Who noted the sweet or honey-like taste of urine in diabetic patients in the 17th century?
Thomas Willis.
What was the purpose of the first Bleeding Time Test described around 3000 years ago?
To measure the duration of blood flow from the skin after rupture.
What was the Coal Miner’s Test used for?
To detect toxic gases using yellow canaries.
Who coined the term Point of Care Testing in the 1980s?
Gerald Kost, measuring CA in WB of liver transplant
What early POC test did Dochez & Avery develop in 1917?
A test for pneumococcal polysaccharide in lobar pneumonia.
What significant development in immunoassays occurred in 1961?
The creation of radioimmunoassay (RIA).
What further advancement in immunoassays happened in 1971?
The development of enzyme-linked immunoassay (ELISA).
What does the sample pad in a lateral flow immunoassay (LFA) do?
It is for sample preparation.
What is contained in the conjugate release pad of an LFA?
Antibodies specific to the target analyte and conjugated to fluorescent or chromogenic particles.
What is the role of the detection zone in an LFA?
To capture the target analyte with immobilized antibodies or antigens.
What do the test line and control line in an LFA indicate?
Positive or negative results.
What does the adsorbent pad in an LFA facilitate?
Capillary flow and prevents backflow.
Who pioneered the development of amperometric enzyme electrodes for glucose determination?
Leland C. Clark
When was the first commercial glucose sensor released?
In 1975 by Yellow Springs Instruments (YSI).
What are the products of glucose oxidation in the presence of glucose oxidase (GOX), oxygen, and water?
Gluconic acid and hydrogen peroxide.
What is the EversenseE3® CGM System?
A 6-month subcutaneous sensor approved by the FDA in 2018 for continuous glucose monitoring.
What regulatory bodies ensure the safety and accuracy of NPT in the USA and EU?
CLIA in the USA and ISO standards in the EU
What are CLIA-waived tests?
Simple procedures cleared by the FDA for home use, with minimal risk of erroneous results.
What has driven the growth of the POCT market?
The significant increase in the number of waived tests.
Name some major players in the POCT market
Abbott, Roche, Johnson & Johnson, Becton Dickinson, Quidel, Danaher, Siemens, and AccuBioTech
What does WHO’s ASSURED acronym stand for?
Affordable, sensitive, specific, user-friendly, rapid, robust, equipment-free, and deliverable.
What is an example of a CLIA-waived POC test for influenza detection?
The Alere Influenza A & B Test
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