Post on 16-Jan-2016
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