The document discusses point-of-care testing for diabetes mellitus. It outlines various tests that can be performed at the point-of-care, including glucose and ketone levels from blood and urine, glycated hemoglobin (HbA1c), and microalbumin levels. The advantages of point-of-care testing are highlighted such as rapid results, portability, and improved patient care. Quality control procedures and guidelines for devices are also summarized. Recent technological advances for continuous glucose monitoring through contact lenses or watches are mentioned.

1. POINT OF CARE TESTING
IN
DIABETES MELLITUSDr. Jayesh Warade
MBBS MD PGDHHCMDCRM
FACB (USA)
NABL As s es s or, NABH -
CPQI H
Cons ul t ant Bi ochemi s t &

3. Laboratory Investigations
Urine
• Glucose
• Ketone
• Protein -
Microalbumin
Blood
• Glucose
• Ketone
• Glycated Hemoglobin

4. Looking for Complications
Need to monitor for long-term complications –
biochemistry is useful as a screen
– Renal
• Plasma creatinine (0.6 – 1.6 mg/dl)
• Urine “microalbumin” - < 30 µg/min in resting
overnight sample
– Lipids
• Fasting triglycerides (< 150 mg/dl)
• Cholesterol (200 mg/dl)
– ? Thyroid function tests
• Autoimmune association IDDM
• May be justified especially in elderly females

5. Acute Complication - Emergencies
Diabetic Ketoacidosis
• arterial blood pH, pO2, pCO2, Na+,
K+

7. POCT
• Point-of-care testing is also known
as extra-laboratory, alternate
site, or near-patient testing.

8. POCT
COMPACTNESS
PORTABILITY
NON LABORATORY
PERSONNEL
FAST
& ACCURATE
IMPROVE
PATIENT CARE
IMMEDIATE
DECISION

9. POCT
CLINICIAN ROOM
EMERGENCY
ROOM
OPERATING
ROOM
HOME CARE
INTENSIVE CARE
UNIT
CAMP
REMOTE
LOCATION

10. POCT in DIABETES
POCT
DM
SMBG
HBA1C
URINE
KETONE
URINE
GLUCOSE
BLOOD
KETONE
URINE
MICROALBUMIN

12. Check list for Glucometer

13. Quality Control Procedure
Objective Comment
Genral consideration - QCP all reagents (control solution
and test strip) must be dated
as to the date opened and the
expiration date
The test strip should only be
exposed to air for three
minutes. Exposure longer than
three minutes will not
guarantee a avalid result.A. When to perfrom quality
control procedure
each day patients samples are
run
whenever glucose readings are
incongruent with clinical
symptoms or lab results.
B. Successfully demonstrate quality control procedures using high
and low control glucose test.
C. Describe troubleshooting steps if quality control checks fall
out of range

14. Factors affecting bedside glucose
testing

15. ASSURED GUIDELINES FOR POCT

16. Guidelines for Glucometer
Guideline Glucose Range Performance Criteria -
Meter Compared to
laboratory results
ISO 15197:2003 <75 mg/dl 95% result ±15%
>75 mg/dl 95% result ± 20 %
ISO 1597:2013
Parkes Error Grid
< 100 mg/dl 95% result ± 15 %
> 100 mg/dl 95% result ± 15 %
Parkes Error Grid:- 99% of results within Zones A and B
CLSI POCT12 –
A3
< 100 mg/dl 98% result ± 12 mg/dl
> 100 mg/dl 98% result ± 12.5 %
FDA < 70 mg/dl 99 % result ± 10 %
> 70 mg/dl 99 % result ± 7 mg/dl
no individual result should exceed ± 20% of the reference method for samples >

17. Parkes Error Grid
• Parkes error grid was developed
as a new tool for evaluating the
accuracy of a blood glucose
meter
• How to Construct and Interpret
an Error Grid for Quantitative
Diagnostic Assays; Approved
Guideline – CLSI EP 27A

19. HBA1C

20. Methodology
• POC HbA1c - results are not affected
by hemoglobin variants, labile glycated
hemoglobin, or hematocrit levels.
• Boronate fluorescence quenching
technology (BFQT), is used - traceable
to well-documented boronate affinity
HPLC systems used in reference
laboratories.
• POCT systems deal with hemoglobin
variants equally as well as HPLC
systems.

21. HbA1C
• Ready-to-use reagent cartridges that
can be inserted straight into the
analyzer
• blood sample are added directly,
• No need for premixing or pipetting.
• Minimizing the number of steps in
the procedure
• reduces user error and standardize
results by eliminating any variation
introduced by different operators

22. HbA1C
• 4 – 10 micro ml of blood
• 3 – 10 min of time

23. Source of Variations
• technologies and among individual
systems.
• heterogeneity of hemoglobins,
• underlying differences in technologies
(e.g., ion exchange, boronate affinity,
immunoassay),
• calibration drifts, or
• lot-to-lot variability.

24. Blood Ketone

25. Blood Ketone
Blood Ketone Testing Enables Rapid
Diagnosis of DKA
• Ketone results in only 10 seconds
allows fast treatment decisions
• Allows immediate differentiation
of simple hyperglycemia from life
threatening ketotic states.

26. Blood Ketone
• POC device measures beta hydroxy
butarate - predominant ketone
present in DKA.
• urine dipstick testing for the
presence acetone

27. Blood Ketone
• >3.0mmol/L, underestimate ketone
meter measurements - capillary blood
• Review venous ketone results

28. Blood Ketone
• All hospitals using POCT capillary
blood ketone testing should be
aware of the possible limitations
when using any bedside meters to
measure blood ketones.

29. Microalbumin

30. Microalbumin
• earliest manifestation of nephropathy,
and
• an independent marker of increased
cardiovascular morbidity and mortality
in diabetic, as well as non-diabetic,
patients.

31. Microalbumin - POC Device
• Excellent precision
• High level of accuracy
• Accurate results within 90 seconds
• Factory calibrated
• Samples up to and including 2000 mg/L can be
obtained with samples diluted with isotonic
sodium chloride
• Analysis can be performed with spot urine,
preferably first morning urine, as well as urine
collected overnight or during 24 hours
• Minimal maintenance
• System can be used by non-laboratory
personnel

32. Shortfalls
• Narrow instrument measuring
range 30-150 mg/dl.
• Reagent needs to be refrigerated

33. Urine - Ketone, Glucose, Protein
• Strip Method

34. Urine Ketone
Positive test result but 'no' ketones
• Some medications:
– Levodopa - eg, Sinemet®
– Phenazopyrazine
– Valproic acid
– Vitamin C
• Dehydration.
False negatives
• Most urine testing kits detect aceto-acetate,
not the predominant ketone beta-
hydroxybutyrate.
• It is possible for the test to be negative with
high levels of beta-hydroxybutyrate and then,
as ketoacidosis improves and ketone levels fall,
the urine test becomes positive (to aceto-
acetate).

35. Urine Protien
• Source of error with reagent strip
occurs with highly buffered alkaline
urine that overrides the acid buffer
system, producing a rise in pH and a
colour change unrelated to protein
concentration.
• Technical error of allowing the reagent
to remain in contact with the urine for a
prolonged period may remove the
buffer.

36. Urine Protien
False-positive
•reaction does not take place under acidic
conditions.
•Highly pigmented urine and
•contamination of the container with
quaternary ammonium compounds,
detergents and antiseptics by altering pH
•high specific gravity

37. Urine Glucose
• False positive: due to the
presence of traces of strong
oxidizing agents or peroxide from
disinfectants used on laboratory
instruments
• False negative: Ascorbic acid
(vitamin C) or fruit juices. Some
dipsticks are affected by
increased specific gravity and
ketonuria.

39. POCT
OPERATION

40. POCT Issues
Complexity of data management and
Oversight
•Training & competency assessment for
•potentially thousands of individuals
•Quality control documentation
•Quality performance
•Reporting
•Billing
•Process control

41. POCT Issues
Complexity of data management and
•oversight
•Multiple testing platforms
•Vendor specific vs vendor neutral data
•management systems
- Interfaces to laboratory and/or
hospital
•information systems
•Manual POCT methods

42. POCT Issues
Importance of process to achieve
•effective use of POCT
•Is faster always better?

43. POCT Lean Benefit
• Rapid turn around time for diagnosis
and management planning
• Patient Convenience
• Reasonable cost
• Improved patient planned care provided.
• Improved office work flow through
increased testing efficiency and less
work call backs
• Reduction of length of stay in ER venues
• Reduced ER and Hospital refferal.

44. Additional POCT Advantages
• Small samples volume
• Portable devices with wide menu of
analytes
• unprocessed specimen
• Ability to provide laboratory
testing in a wider variety of sites
or circumstances.
• Reduced potential for sample
deterioration

54. Recent Advances
A contact lens with embedded circuitry
to monitor blood glucose levels

55. Recent Advances

56. CGM - Watch

57. CGM

58. Transmitter on skin

59. Related Article
• Organization of POCT unit
www.ifcc.org/media/331818/eJIFCC2015Vol26No2pp125-132.pdf
• POCT: Taking control in uncontrolled premises - Part 1
http://acutecaretesting.org/en/articles/poct-taking-control-in-
uncontrolled-premises
• POCT: Taking control in uncontrolled premises - Part 2
http://acutecaretesting.org/en/articles/poct-taking-control-in-
uncontrolled-premises-part-ii
• Challenges in POCT
http://www.researchpublish.com/download.php?file=CHALLENGES%20IN
%20POCT-721.pdf&act=book
• Quality Control Aspect of POCT
www.wjpr.net/download/article/1415190780.pdf
• Comparison of BiliCare TCB with Central Laboratory
• Comparison of Various Glucometers Against Central
Laboratory
• Comparison of iStat with Central Laboratory

60. Email: jdyajdo@gmail.com
9028219916
9028219916
http://clinlabworld.blogspot.in/