LECTURE 2

Question 1

What is believed to be the earliest diagnostic test, dating back to 1500 BC?

Answer 1

Urine testing for diabetes.

Question 2

By the 1600s, how was diabetes diagnosed?

Answer 2

Tasting urine.

Question 3

Who noted the sweet or honey-like taste of urine in diabetic patients in the 17th century?

Answer 3

Thomas Willis.

Question 4

What was the purpose of the first Bleeding Time Test described around 3000 years ago?

Answer 4

To measure the duration of blood flow from the skin after rupture.

Question 5

What was the Coal Miner’s Test used for?

Answer 5

To detect toxic gases using yellow canaries.

Question 6

Who coined the term Point of Care Testing in the 1980s?

Answer 6

Gerald Kost.

Question 7

What early POC test did Dochez & Avery develop in 1917?

Answer 7

A test for pneumococcal polysaccharide in lobar pneumonia.

Question 8

What significant development in immunoassays occurred in 1961?

Answer 8

The creation of radioimmunoassay (RIA).

Question 9

What further advancement in immunoassays happened in 1971?

Answer 9

The development of enzyme-linked immunoassay (ELISA).

Question 10

What does the sample pad in a lateral flow immunoassay (LFA) do?

Answer 10

It is for sample preparation.

Question 11

What is contained in the conjugate release pad of an LFA?

Answer 11

Antibodies specific to the target analyte and conjugated to fluorescent or chromogenic particles.

Question 12

What is the role of the detection zone in an LFA?

Answer 12

To capture the target analyte with immobilized antibodies or antigens.

Question 13

What do the test line and control line in an LFA indicate?

Answer 13

Positive or negative results.

Question 14

What does the adsorbent pad in an LFA facilitate?

Answer 14

Capillary flow and prevents backflow.

Question 15

Who pioneered the development of amperometric enzyme electrodes for glucose determination?

Answer 15

Leland C. Clark

Question 16

When was the first commercial glucose sensor released?

Answer 16

In 1975 by Yellow Springs Instruments (YSI).

Question 17

What are the products of glucose oxidation in the presence of glucose oxidase (GOX), oxygen, and water?

Answer 17

Gluconic acid and hydrogen peroxide.

Question 18

What is the EversenseE3® CGM System?

Answer 18

A 6-month subcutaneous sensor approved by the FDA in 2018 for continuous glucose monitoring.

Question 19

What regulatory bodies ensure the safety and accuracy of NPT in the USA and EU?

Answer 19

CLIA in the USA and ISO standards in the EU

Question 20

What are CLIA-waived tests?

Answer 20

Simple procedures cleared by the FDA for home use, with minimal risk of erroneous results.

Question 21

What has driven the growth of the POCT market?

Answer 21

The significant increase in the number of waived tests.

Question 22

Name some major players in the POCT market

Answer 22

Abbott, Roche, Johnson & Johnson, Becton Dickinson, Quidel, Danaher, Siemens, and AccuBioTech

Question 23

What does WHO’s ASSURED acronym stand for?

Answer 23

Affordable, sensitive, specific, user-friendly, rapid, robust, equipment-free, and deliverable.

Question 24

What is an example of a CLIA-waived POC test for influenza detection?

Answer 24

The Alere Influenza A & B Test.

Question 25

What device is used at events like the Boston Marathon to monitor electrolytes, sodium levels, lactic acid, and cardiac markers?

Answer 25

Abbott’s i-STAT System.

Question 26

What are some promising developments for the future of NPT/POCT?

Answer 26

New tests like nucleic acid amplification tests (NAATs), application of COVID-19 technology to other diseases, growing patient expectations for immediate results, expanding use-case scenarios, continued focus on quality management, and advancements in technical features, diagnostic accuracy, ease of use, cost-effectiveness, and data management.