i-STAT®

Portable Clinical Analyser

Paul Lymer, B.Sc.

European Sales Manager

Woodley Equipment Company Ltd.

i-STAT®

Portable Clinical Analyser

What do you want?

€ € € € € € € € € € € € € € € € € € € € € € € € € € € € € € € € € € € €

How do you obtain what you want?

Know your customer!

Who are the Decision Makers?

“It is most unwise and highly inadvisable to engage in a census of the offspring of one’s hen prior to the actual termination of the embryonic

stage and the actual removal of the young organism’s embryonic shell.”

“Don’t count your chickens before they hatch.”

i-STAT® Portable Clinical Analyser

What is its purpose?

i-Stat® Portable Clinical Analyser

So much information

withSo little blood

inSo little So little timetime

Commonly Requested Critical Care Tests

• Electrolytes: Sodium; Potassium; Chloride; Ionized Calcium

• Blood Gases: pCO2; pO2; sO2†

• Acid Base: pH; pCO2; Bicarbonate†; TCO2†; Base Excess†; Anion Gap†

• Chemistries: Glucose; BUN; Creatinine; Lactate

• Haematology: Haematocrit; Haemoglobin†

• Coagulation: ACT

† calculated value

Electrolytes

• Sodium• Chloride• Potassium• ionized Calcium

Electrolytes: Clinical Value

• Out-of-range values result in poor nerve conduction and muscle contraction

• Weakness, lethargy

Electrolytes & Nerve Conduction

Membrane

Membrane

Inside

Na+ ClK+

~10mM~150mM

~ 4mM ~140mM ~100mM

~5mM - 90 mV

Na + ClK +

~ 4mM ~140mM ~100mM

+ 20 mV

Nerve Action Potential

-100

-80

-60

-40

-20

0

20

40

0 0.5 1 1.5 2 2.5 3

Time (msec)

Resting State Active State

~40mM ~40mM ~10mM

Ionized Calcium

• Biologically active fraction• Importance

– Blood coagulation– Nerve Conduction– Neuromuscular transmission– Muscle contraction

Blood Gas & Acid-Base

Blood Gases

• Oxygen– pO2

– sO2

• Carbon dioxide– pCO2

Acid Base

• pH• pCO2

• HCO3

• TCO2

• Base excess• Anion gap

Respiratory Component

• Function of the lungs• Carbonic acid H2CO3

• Approximately 98% normal metabolites are in the form of CO2

• CO2 + H2O H2CO3

• Excess CO2 exhaled by the lungs

Blood Gases & Acid Base

• Function of the kidneys

• Base bicarbonate NaHCO3

• Process of kidneys excreting H+ into the urine and reabsorbing HCO3

- into the blood from the renal tubules

Metabolic Component

Blood Gases & Acid Base

Acid/Base

Normal Values

Blood Gases & Acid Base

Rule of “4s”

pH 7.35 – 7.45 (7.4 ± 0.04)

pCO2 35 – 45 mmHg (40)

pO2 80 – 100 mmHg

HCO3 22 – 26 mmol/L (24)

BE -2 - +2

SaO2 >95%

Acidosis AlkalosispH < 7.35

PCO2 > 45

HCO3 < 22

pH > 7.45

PCO2 < 35

HCO3 > 26

Acid Base

• Drug overdose

• Respiratory arrest

• Airway obstruction

Causes of Respiratory Acidosis

Blood Gases & Acid Base

• Failure of kidney function

• Decrease in Blood HCO3 which results in decreased availability of renal tubular HCO3 for H+ excretion

• pH < 7.35

• HCO3 < 22

Metabolic Acidosis

Blood Gases & Acid Base

• Renal failure

• Diabetic ketoacidosis

• Lactic acidosis

• Sepsis

• Excessive diarrhea

• Cardiac arrest

Causes of Metabolic Acidosis

Blood Gases & Acid Base

Glucose

BUN & Creatinine

100%

0%

25%

Increased BUN & Creatinine

• Assessment of non-perfusion of tissues resulting in the catabolic production of glucose to lactic acid

• Aerobic metabolism provides 36 moles of ATP per mole of glucose versus 2 moles of ATP for anaerobic metabolism

Lactate: Clinical Value

Normal Aerobic Metabolism Anaerobic Metabolism

Efficient:

=> 36 moles of ATP/ 1 mole glucose

Inefficient:

=> 2 moles of ATP/ 1 mole glucose

Lactate Production

• When is it elevated?• Periods of high stress - major surgery, trauma, hypovolemia when glucose levels rise

• Compromised oxygen delivery - trauma, sepsis resulting in tissue hypoxia

• What is the impact?• Irreversible cellular damage

• Increased potential of multi-organ failure

• Immediately increases mortality rates to >85%

Lactate Occurrence & Impact

Haematocrit & Haemoglobin

Sample Handling: Haematocrit

• Cells start to settle immediately after blood is drawn.

• Most cases of discrepant haematocrit results are due to inadequate sample mixing.

• Mix collection device and discard one or two drops from a syringe immediately before filling a cartridge.

ACT (Activated Clotting Time)

• Measure of ability to clot• Intrinsic and Common Pathways• Normal

– Dogs 90-110 seconds– Cats 100-160 seconds

• No anticoagulant in the sample!!!

Sample Handling: Coagulation

• Do not use collection devices with anticoagulant.

• Use only plastic collection devices. - Tubes - Syringes - Capillary tubes

Introduction to

i-STAT Technology

Technology• Same sensors as used on

traditional analysers

• Industry standard electrochemical sensor technology

• Benefit of single-use sensor technology is that every time a cartridge is run, the sensors are “new”

Expanded view of Fluid Electrical Resistant Measuring Device

Same Fluid Path and Fluid Flow

CALIBRANT

FLUSHING SOLUTION

WASTE

VALVE

SAMPLE INPUT

PUMP

ELECTRODES

Traditional i-STAT

WASTE

PUMP

SAMPLE INPUT

CALIBRANT

Cartridge Manufacturing

Biosensor chip

i-STAT Cartridg

ePackaging, Samplingand Testing

Cartridge assembly

Cartridge label

sample entry well gasket

cartridge cover

fluid channel

sample entry well

tape gasket

biosensor chip

calibrant pouch

puncture barb

cartridge base

air bladder

Wet lab

Acceptable Sample Types

& Sample Handling

Sample TypesBlood Gases and Chemistries

• Fresh whole blood without anticoagulant• Fresh whole blood with heparin anticoagulant

– Use in cats or if testing could be delayed• Heparin can be:

– Lithium heparin (blood collection tube, blood gas syringe)– Balanced heparin (blood gas syringe/capillary tube)– Low volume heparin (blood gas syringe)

Sample Types

• No anticoagulant for ACT cartridges

• Serum and plasma are the liquid portion of the bloodseparated from the cellular portion

– i-STAT labelling does not support serum or plasma for any other test

– Electrolytes and chemistries can be run on serum or plasma(Heska internal research)

Sample Types

Blood can be from any site:Arterial Venous

No other sample is recommended - may cause out-of-range, * * *, or inaccurate results due to matrix affects

No other anticoagulant is recommended - may get ***, or inaccurate results due to interference

Sample Handling: Blood Gases• Use plain syringe or pre-heparinized blood gas syringe labelled

for electrolytes (or at least ionized calcium) when testing for electrolytes.

– The on-site heparinization of syringes is not recommended. Heparin must not exceed 10 U/mL blood.

Use of unbalanced heparin will reduce ionized calcium results significantly and may reduce sodium and potassium results.

• Fill pre-heparinized syringes to recommended capacity.• Do not tap out an air bubble if it is on the tip of the syringe

plunger.• If using a plain syringe, test immediately.

Arterial blood gas sampling in small animals

Indications for arterial blood gas sampling and catheterization

• Sampling• Haemodynamic instability• Respiratory compromise• Renal disease• Severe disease

Sites of arterial puncture and catheterization

• dpa=dorsal pedal artery

• fa=femoral artery• pa=palmar arch

Dorsal pedal artery puncture and catheterization

• Animal in lateral recumbency• Dorsal pedal artery, branch of

cranial tibial artery located near hock

• Runs lateral to medial, proximal to distal over dorsal surface of hock

• Circle denotes site of entry

Femoral artery puncture and catheterization

• Animal in lateral recumbency• Femoral artery located in femoral

triangle• Landmarks

– Cranial: femur– Caudal: pectineus muscle.

• Circle denotes site of entry

Palmar arch puncture and catheterization

• Animal in lateral recumbency with forelimb extended• Palmar arch is branch of median artery• Located on palmar surface of forefoot abaxial to first digit and distal to

carpal pad• Circle denotes site of entry

Preparation of sites for arterial puncture

• Assess circulation and identify landmarks• Clip hair• Warm areas to increase circulation and vessel dilation• Sterile preparation• +/- Local anesthetic infiltration

Arterial puncture or catheterization

Time Allowed From Blood Draw to Test

Test Time Allowed

Electrolytes, Chemistries, Haematocrit

30 minutes

Blood gases 10 minutes

Lactate 3 minutes

ACT Immediate

No anticoagulant, capillary tubes Immediate

Benefits of i-STAT System

• If testing is immediate, no anticoagulant is necessary.(except in cats)

• A clot only wastes one cartridge – a clot makes a multi-use blood gas analyser inoperable.

• Small sample volume.

How can the i-STAT analyser improve patient care?

Therapeutic Turnaround Time

(“vein to brain” time)

Testing Needs

by Disease Condition

Daytime Clinics

• Vomiting/Diarrhea• Lethargy• Dermatitis• Coughing/Sneezing/Wheezing• HBC

Emergency Clinics

• Vomiting/Diarrhea• Trauma

– HBC– Dog and cat fight wounds

• Urethral obstruction

Vomiting/Diarrhea

Hughie

Diarina

Vomiting/Diarrhea

• Concerns– Dehydration

• Hct• BUN

– Acid-base– Electrolytes

• Na, K, Cl– Glucose

• Cartridge of choice– EC8+– E3+– CG8+

Lethargy/Stupor

• Concerns– Dehydration

• Hct• BUN

– Glucose– Electrolytes

• Na, Cl, K– Acid-base

• Cartridge of choice– EC8+

Coughing, Sneezing, WheezingDifficulty Breathing

• Concerns– Oxygen– CO2

– Acid base– Lactate

• Coughing/sneezing blood

• Cartridges of choice– CG4+– +/- ACT

HBC

• Concerns– Haematocrit/Haemoglobin– Blood gases

• pO2• pCO2

– Lactate– Coagulation

• Cartridges of choice – CG4+– ACT– 6+

Renal Disease

• Concerns– BUN– Creatinine– Electrolytes

• Na, K, Cl– Acid-base

• Cartridge of choice– EC8+– Crea– E3+

Blocked cats

• Concerns– BUN/Creatinine– Electrolytes

• Na, Cl, K– Acid-base– Haemoglobin/haematocrit

• Cartridge of choice– EC8+– E3+

Antifreeze Poisoning

• Concerns– BUN– Creatinine– Electrolytes

• Na, K, Cl– Acid-base

• Cartridge of choice– EC8+– Crea– E3+

Diabetes mellitus

• Concerns for acute diabetes

– Glucose– Acid-base– Concerns for

regulation– Glucose

• Cartridge of choice for acute diabetes

– EC8+– CG8+

• Cartridge of choice for regulation

– G

BloatGastric Dilatation/Volvulus

• Concerns– Acid-base– Electrolytes

• Na, Cl, K– Glucose– Lactate– BUN– Haematocrit/haemoglobin

• Cartridge of choice– EC8+– CG4+

Preanesthetic Screen

• Concerns– Kidney function– Liver function– Glucose– Electrolytes– Haemoglobin/haematocrit– Coagulation +/-

• Cartridges of choice– 6+– ACT

Long Anesthetic Procedures

• Concerns– Blood gases

• pO2• pCO2

– Acid-base– Lactate– Haematocrit/haemoglobin

• Cartridge of choice– CG4+

Seizures

• Concerns– Glucose– Electrolytes

• Na, K, Cl, iCa– Acid-base– Lactate

• Cartridge of choice– CG8+– CG4+– E3+

Critical Care

• Concerns– Electrolytes– Acid-base– Glucose– BUN– Haematocrit/haemoglobin– +/- blood gases

• Cartridges of choice– EC8+– CG8+

Bleeding

• Concerns– Coagulation– Haematocrit/haemoglobin

• Cartridge of choice– ACT– E3+

Anemia

• Concerns– Haematocrit/haemoglobin– Oxygen

• Cartridges of choice– EG6+– EC4+

Hypothermia

• Concerns– Blood gases

• pO2• pCO2

– Acid-base– Lactate

• Cartridge of choice– CG4+

Hyperthermia

• Concerns– Blood gases– Acid-base– Electrolytes– Lactate– BUN– Coagulation

• Cartridges of choice– CG4+– EC8+– ACT

Septic Shock

• Concerns– Blood gases– Lactate– Acid-base

• Cartridge of choice– CG4+

Sick Adrenal Glands

• Concerns– Sodium– Potassium– Acid-base

• Cartridges of choice– EC8+– 6+

Obstetrics

• Concerns– Ionized calcium– Glucose– Acid-base

• Cartridge of choice– CG8+

Pediatrics

• Concerns– Glucose– Electrolytes

• Na, K, Cl, iCa

• Cartridges of choice– 6+– G

Geriatric checkup

• Concerns– Kidney function– Liver function– Glucose– Electrolytes– Haemoglobin/haematocrit– Calcium

• Cartridges of choice– EC8+– CG8+

Post Thyroid GlandRemoval

• Concerns– ionized calcium

• Cartridge of choice– CG8+

Competition

i-STAT® Portable Clinical Analyser

– IRMA (electrolytes/blood gases)• Diametrics Medical

(Phillips Corp)

– IDEXX® Corporation• VetLyte(electrolytes)• VetStat (electrolytes/blood gases)

                     

                                                                 

Competition

IRMAIRMA SL Blood Gas Analysis System

Primarily Blood Gas(Acid Base) and Electrolytes • Only one chemistry – BUN• Hct only • Only 4 cartridges to choose from!

IRMAIRMA SL Blood Gas Analysis System

Primarily Blood Gas(Acid Base) and Electrolytes

• Room temp cartridge storage – 6 month dating(short)• Touch screen• Battery or A/C powered (20-40 tests per charge) - 2 lbs.- 2-3 hour

charge• 5 lbs. (analyzer only)

IRMAIRMA SL Blood Gas Analysis System

Primarily Blood Gas(Acid Base) and Electrolytes

• Tricky luer-lock attachment for sampling• Built in printer• 11.5” Long x 9.5” Wide x 5” High• Auto-Calibration and Quality Control

i-STAT® vs. IRMA

• Both systems are cartridge based

• i-STAT® can do more testing– Electrolytes + Chemistries + Blood Gases + Acid Base + mini-

Haematology– Some clinics use as their primary system with EC8+ as their panel /

pre-surgical

The i-STAT® Portable Clinical Analyser is the ‘de facto’ standard in veterinary clinics

IDEXX® VetLyte®

• Fixed Base – A/C powered – not portable

• “Wet” System – continuous fluid – from human market– Must keep electrodes wet– Cycles when not in use– Can be very inefficient at lower volumes

• ONLY performs Electrolytes– Na+, K+, Cl- – Serum or Li Heparin only – no whole blood

IDEXX® VetLyte®

• IDEXX ‘bundles’ with VetTest and LaserCyte– Will give ‘free’ unit to higher volume clinics– Should be ‘QC’d daily – often ignored

• Maintenance– About €750/year in electrode replacement– Daily, weekly, monthly, 6 months, and ‘annual’

i-STAT® vs. VetSTAT™

4.7 X 14.2 X 9.1 inches

11 pounds

with battery

2.52 X 8.26 X 2.05 inches

22.9 oz

i-STAT® vs. VetSTAT™

i-STAT VetSTAT

Portable Yes Yes

Power Lithium batteries AC or optional rechargeable battery

Species-specific ranges No Canine, Feline, Equine

Time of analysis 120 seconds Calibration 90 secAnalysis 120 sec

Cassettes Single-use Single-useCassette storage Refrigeration Room Temp

i-STAT® vs. VetSTAT™

i-STAT VetSTAT

Blood gases p02, s02, pCO2 pO2, pCO2

Acid-base pH, pCO2, HCO3, TCO2, BE, AG

pH, pCO2, HCO3, TCO2, AG

Electrolytes Na, K, Cl, iCa Na, K, Cl, iCa

Chemistries Glucose, BUN, Creatinine, Lactate

Glucose

i-STAT® vs. VetSTAT™

i-STAT VetSTAT

Cartridge Types 9 5

Cartridges/package 5 or 25 12

Measurement Principle

Electrochemical, Electrogenic

Fluorescence, Reflectance

Sample type Whole blood Whole blood, serum, plasma

IDEXX VetStat

Primarily Blood Gas (Acid Base)

and Electrolytes

• Room temp cassette storage – 6 month dating(short)• Touch screen

Reusable Traditional Blood Gas Analyzers

Radiometer-ABL NOVA

IL-SynthesisBayer-Chiron

EC8+

• Sodium• Potassium• Chloride• BUN• Glucose• Haematocrit• Hemoglobin

• pH• pCO2• TCO2• HCO3• Base Excess• Anion Gap

CG8+

• Sodium• Potassium• Ionized Calcium• Glucose• Haematocrit• Hemoglobin

• pH• pCO2• pO2• sO2• TCO2• HCO3• Base Excess

CG4+

• pH• pCO2• pO2• sO2• TCO2• HCO3• Base Excess• Lactate

U.S. Cartridge Sales

Percent Sales

EC8+, 37%

ACT, 6%E3+, 17%CG4+, 4%

6+, 12%

Crea, 4%

G, 11%CG8+, 8% EC4+, 1%

Cartridge Type

Percent Sales

EC8+ 37%E3+ 17%6+ 12%G 11%CG8+ 8%ACT 6%CG4+ 4%Crea 4%EC4+ 1%

UK Cartridge Sales

ACT, 3%

CG8+, 33%

Crea, 2%E3+, 12%CG4+, 5%

EC8+, 46%

Cartridge Type

Percent Sales

EC8+ 46%

CG8+ 33%

E3+ 12%

CG4+ 5%

ACT 3%

Crea 2%

Why would a vet want an I-STAT?

How can a vet run his practice without an I-STAT?

Heska in the USA >3000 units

Woodley in the UK >160 units