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Waltham, MA
USA
Nova Biomedical Corporation
Waltham, MA Bedford, MA
No. 282 StatStrip Glucose Int Rev. 8/26/2011
1978 First biosensor for Ionized Calcium
1980 First biosensor to measure Chloride in blood
1984 First biosensor to measure Total Calcium
1985 First biosensor to measure Hematocrit by ISE/Conductivity
1987 First biosensor to directly measure whole blood Glucose
1988 First biosensor to measure Lithium
1990 First biosensor to measure BUN (urea)
1992 First biosensor to directly measure whole blood Lactate
1994 First biosensor to measure Ionized Magnesium
1996 First biosensor to measure Creatinine
1996 First biosensor to measure Total CO2 in whole blood
1997 First multi-wavelength fiber optic SO2% assay
1998 First fiber optic Hemoglobin assay
1998 First Ammonium biosensor
1999 First non-diluting direct Glutamine biosensor
1999 First non-diluting direct Glutamate biosensor
2001 First Acetate biosensor
2005 First Hematocrit corrected Glucose strip
2007 First calibration free Glucose strip
2007 First Creatinine strip and meter
2009 First calibration free Ketone strip
2009 First IgG assay on a biotechnology analyzer
2010 First Hematocrit corrected hospital Lactate meter and strip
Nova BioSensor Firsts
Nova is the World Leader in
Whole Blood Biosensors
Bolnički mjeraći uz bolesnikov krevet
Oba mjerača imaju odobrenje FDA za
upotrebu u zdravstvenim ustaovama
Oba glukometra eliminraju kalibracijski kod
Dva glukometra – jedna precizna i točna traka
bez interferencija
StatStrip®
Hospital Connectivity Meter
Bolnički glukometar
Multi-WellTM
Tehnologija daje novi nivo analitičkih performansi
Bolnički mjerač sa svim podacima mjerenja
poveziv sa BIS i LIS
Xpress Meter glukometar za
dijabetičare, bolnice, hitnu pomoć…
Glucose/Ketone Monitor
StatStrip®
Xpress Hospital Meter
Nove test trakice
- Patentirana “strip” tehnologija kompanije Nova Biomedical
- Mjeri i otklanja interferencije
- Analitička točnost i preciznost /usporedivo sa laboratorijskim
nalazom
- Kalibracijski kodovi nisu potrebni
- Mali volumen krvi 1,2 µl pune krvi
- Rezultati unutar 6 sekundi
- Kontrola testiranje
- Izbor od dva mjerača
Bez interferencija na
- Hematokrit
- Maltozu
- Galaktozu
- Ksilozu
- Bilirubin
- Kisik
- Acetoaminofen
- Askorbinska kiselina
- Mokraćnu kiselinu
- Kolesterol
— smanjuje broj koraka
— bitno smanjuje korisničke greške
— greške kod rezulta glukoze višlje od 43% mogu biti uzrokovane
netočnim kalibracijskim kodom
— StatStrip lot je zamjenjiv
StatStripTM
Multi-WellTM
tehnologija
StatStrip uklanja kalibracioni kod
Patent: US#6,287,451;6,837,976;EP#1 212 609;CA 2,375,092
StatStripTM
Multi-WellTM
tehnologija
površinski sloj
— odušnik za brzi protok uzorka
— preventivana zaštita od kontaminacije
mikro kapilarni sloj
— 1.2 µL uzorkovna količina
— ne može se prepuniti
mjerni sloj
mjerenje interferencija + mjerenje glukoze
— mjerenje elektrokemijskih interferencija
— hematokrit
— referentna
– četvrti otvor (početak analiza i uklanjanje premale
količine uzorka)
zlatni sloj
— plemeniti metal; stabilan u svim uvjetima i pri rukovanju
— elektrokemijska mjerna podloga
— izvrsna električna provodljivost
StatStrip
TM
Multi-Well
TM
tehnologija
mjeri i eliminira hematokrit interferenciju
učinak hematokrit interferencije
Hematocrit Interference Effect
pokazatelj promjene nivoa hematokrita na senzorom obiljepokazatelj promjene nivoa hematokrita na senzorom obilježženoj plohienoj plohi
% Hct 25
rezultati glukoze
umjetno povišeni za 25%
% Hct 45
rezultati glukoze
normalni
% Hct 65
rezultati glukoze
umjetno sniženi za 25%
Promjena vrijednosti hematokrita
ustaljen je kod sljedećih bolesnika:
— neonatološki bolesnici
— srčani bolesnici
— bolesnici na dijalizi
— onkološki bolesnici
— traumatolški bolesnici
— teško anemični bolesnici
— starija populacija -30%
-20%
-10%
0%
10%
20%
30%
25% 60%45%
greške u % tjekom određivanja hematokrita
rezultati glucoze
sa greškom Hct.
rezultati glucoze
mjerenjem Hct
i korekcijom
hematokrit
greškeuHct
StatStrip
TM
Multi-Well
TM
tehnlogija
mjeri i eliminira hematokritnu interferenciju
Multi-Well
TM
kreativna tehnologija
novi način analitičke učinkovitosti
za korištenje uz bolesnika
brzo i jednostavno mjerenje glukoze uz bolesnika
1 - umetnuti test trakicu
2 - uzeti uzorak
3 - dodati uzorak
4 - rezultat za 6-sekundi
u izboru dva mjerača– nepotreban kalibracijski kod
StatStripTM
brzi mjerač
— laboratorijska kvaliteta, točnost i preciznost
— Mjerni raspon 0.5 do 33.3 mmol/L
— mjeri i eliminira interferencije
— brzi rezultat, 6 sekundi
— eliminirani kalibracijske kodove
— memorija 400 testova
— trajanje baterije 600 testova
— težina 75g
StatStripTM
brzi mjerač
Xpress
TM
StatStrip
TM
brzo i jednostavno mjerenje glukoze uz bolesnika
StatStrip®
Has Earned Worldwide Scientific Acclaim
Partneri Nove biomedical
•Vodeće svjetske kompanijeVodeće svjetske kompanije Kompanije u razvojuKompanije u razvoju
ThermoElectron
LifeScan Division
Sterilization DivisionClintec Division
Fenwal Division
Renal Division
Mission Medical Inc.

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Dijabetes prezentacja

  • 1. Waltham, MA USA Nova Biomedical Corporation Waltham, MA Bedford, MA No. 282 StatStrip Glucose Int Rev. 8/26/2011
  • 2. 1978 First biosensor for Ionized Calcium 1980 First biosensor to measure Chloride in blood 1984 First biosensor to measure Total Calcium 1985 First biosensor to measure Hematocrit by ISE/Conductivity 1987 First biosensor to directly measure whole blood Glucose 1988 First biosensor to measure Lithium 1990 First biosensor to measure BUN (urea) 1992 First biosensor to directly measure whole blood Lactate 1994 First biosensor to measure Ionized Magnesium 1996 First biosensor to measure Creatinine 1996 First biosensor to measure Total CO2 in whole blood 1997 First multi-wavelength fiber optic SO2% assay 1998 First fiber optic Hemoglobin assay 1998 First Ammonium biosensor 1999 First non-diluting direct Glutamine biosensor 1999 First non-diluting direct Glutamate biosensor 2001 First Acetate biosensor 2005 First Hematocrit corrected Glucose strip 2007 First calibration free Glucose strip 2007 First Creatinine strip and meter 2009 First calibration free Ketone strip 2009 First IgG assay on a biotechnology analyzer 2010 First Hematocrit corrected hospital Lactate meter and strip Nova BioSensor Firsts Nova is the World Leader in Whole Blood Biosensors
  • 3. Bolnički mjeraći uz bolesnikov krevet
  • 4. Oba mjerača imaju odobrenje FDA za upotrebu u zdravstvenim ustaovama Oba glukometra eliminraju kalibracijski kod Dva glukometra – jedna precizna i točna traka bez interferencija StatStrip® Hospital Connectivity Meter Bolnički glukometar Multi-WellTM Tehnologija daje novi nivo analitičkih performansi Bolnički mjerač sa svim podacima mjerenja poveziv sa BIS i LIS Xpress Meter glukometar za dijabetičare, bolnice, hitnu pomoć… Glucose/Ketone Monitor StatStrip® Xpress Hospital Meter
  • 5. Nove test trakice - Patentirana “strip” tehnologija kompanije Nova Biomedical - Mjeri i otklanja interferencije - Analitička točnost i preciznost /usporedivo sa laboratorijskim nalazom - Kalibracijski kodovi nisu potrebni - Mali volumen krvi 1,2 µl pune krvi - Rezultati unutar 6 sekundi - Kontrola testiranje - Izbor od dva mjerača
  • 6. Bez interferencija na - Hematokrit - Maltozu - Galaktozu - Ksilozu - Bilirubin - Kisik - Acetoaminofen - Askorbinska kiselina - Mokraćnu kiselinu - Kolesterol
  • 7. — smanjuje broj koraka — bitno smanjuje korisničke greške — greške kod rezulta glukoze višlje od 43% mogu biti uzrokovane netočnim kalibracijskim kodom — StatStrip lot je zamjenjiv StatStripTM Multi-WellTM tehnologija StatStrip uklanja kalibracioni kod
  • 8. Patent: US#6,287,451;6,837,976;EP#1 212 609;CA 2,375,092 StatStripTM Multi-WellTM tehnologija površinski sloj — odušnik za brzi protok uzorka — preventivana zaštita od kontaminacije mikro kapilarni sloj — 1.2 µL uzorkovna količina — ne može se prepuniti mjerni sloj mjerenje interferencija + mjerenje glukoze — mjerenje elektrokemijskih interferencija — hematokrit — referentna – četvrti otvor (početak analiza i uklanjanje premale količine uzorka) zlatni sloj — plemeniti metal; stabilan u svim uvjetima i pri rukovanju — elektrokemijska mjerna podloga — izvrsna električna provodljivost
  • 9. StatStrip TM Multi-Well TM tehnologija mjeri i eliminira hematokrit interferenciju učinak hematokrit interferencije Hematocrit Interference Effect pokazatelj promjene nivoa hematokrita na senzorom obiljepokazatelj promjene nivoa hematokrita na senzorom obilježženoj plohienoj plohi % Hct 25 rezultati glukoze umjetno povišeni za 25% % Hct 45 rezultati glukoze normalni % Hct 65 rezultati glukoze umjetno sniženi za 25%
  • 10. Promjena vrijednosti hematokrita ustaljen je kod sljedećih bolesnika: — neonatološki bolesnici — srčani bolesnici — bolesnici na dijalizi — onkološki bolesnici — traumatolški bolesnici — teško anemični bolesnici — starija populacija -30% -20% -10% 0% 10% 20% 30% 25% 60%45% greške u % tjekom određivanja hematokrita rezultati glucoze sa greškom Hct. rezultati glucoze mjerenjem Hct i korekcijom hematokrit greškeuHct StatStrip TM Multi-Well TM tehnlogija mjeri i eliminira hematokritnu interferenciju
  • 12. za korištenje uz bolesnika brzo i jednostavno mjerenje glukoze uz bolesnika 1 - umetnuti test trakicu 2 - uzeti uzorak 3 - dodati uzorak 4 - rezultat za 6-sekundi u izboru dva mjerača– nepotreban kalibracijski kod StatStripTM brzi mjerač
  • 13. — laboratorijska kvaliteta, točnost i preciznost — Mjerni raspon 0.5 do 33.3 mmol/L — mjeri i eliminira interferencije — brzi rezultat, 6 sekundi — eliminirani kalibracijske kodove — memorija 400 testova — trajanje baterije 600 testova — težina 75g StatStripTM brzi mjerač Xpress TM StatStrip TM brzo i jednostavno mjerenje glukoze uz bolesnika
  • 14. StatStrip® Has Earned Worldwide Scientific Acclaim
  • 15. Partneri Nove biomedical •Vodeće svjetske kompanijeVodeće svjetske kompanije Kompanije u razvojuKompanije u razvoju ThermoElectron LifeScan Division Sterilization DivisionClintec Division Fenwal Division Renal Division Mission Medical Inc.

Editor's Notes

  1. Nova has a rich history of pioneering the development of dozens of assays and biosensor measurement technologies. When presenting for a group interested in glucose, highlight the fact that we developed the first biosensor to directly measure whole blood glucose and that this has been miniaturized into a test strip based biosensor. Remind them that a lot of technology development has gone into the creation of the StatStrip strip. For a creatinine audience, a similar tie can be made to our development of a creatinine sensor in 1996.
  2. Every other hospital glucose system requires calibration codes. Calibration codes add an extra operator step and can lead to a possible operator error. Given the large number of POC operators and the large number of bedside glucose tests performed, such errors will surely happen. An incorrect cal code can result in a Glucose reading error. Articles have suggested glucose errors due to miscoding can be as high as 40%. All StatStrip lots are consistent and do not require calibration codes
  3. See Talk Tracks
  4. This slide illustrates the hematocrit interference on competitive glucose strips. The circles represents the electrode measurement area for all glucose POC meters. The red dots represent red blood cells. The red blood cells block the measurement surface of the test strips. The center circle represents a normal blood cell. 45% of the reaction area is blocked with the red cells leaving 55% available for measuring the glucose in the plasma. Without the ability to measure the patient’s true hematocrit, competitive meters have to use a “normal” hematocrit value to calibrate their measurement algorithms. The further the patient’s actual Hct value is from the chosen calibration point, the higher the error introduced. The circle to the left represents a low hematocrit. At a 25% Hct, there is 50% more measurement surface exposed to the plasma glucosen and as a result, the reported glucose is higher that the actual value. Low Hct is very common in the critical care areas. Patients that have experienced trauma, hema-diluted procedures, post-delivery mothers, oncology patients and many others experience anemia’s. The circle to the right is the opposite. A higher Hct blocks more measurement surface and lowers the reported glucose values. NICU and dehydrated patients are among the populations that will experience significant compromised care if your glucose analyzer does not measure and correct for the hct interference. Only StatStrip MEASURES and CORRECTS for the glucose measurement error caused by a patient’s abnormal hematocrit.
  5. This slide illustrates the hematocrit interference in a different way. The further away from the normal Hct value (45%) the greater the Hct interference. The interference is inversely related to the Hct value. High HCT gives falsely low glucose readings and low Hct gives falsely high glucose readings. Low Hct is the most common of the two conditions and can contribute to falsely high glucose results and overdosing of insulin. Low Hct is therefore potentially more dangerous. As your hospital becomes more aggressive in Glycemic control, the concern is to prevent driving the patient into a hypoglycemic event. If your glucose meter has an interference at a low hematocrit, the meter may read higher glucose values than the patients actual glucose, resulting in a possible insulin over-dose or a delay in identifying a serious hypoglycemic event. StatStrip measures and corrects for hematocrit enabling better glucose accuracy, improved insulin dosing, and reducing the risk of hypoglycemia
  6. StatStrip is the first meter and strip designed for the current, more demanding requirements of bedside glucose testing. These demands include the need for lab-like analytical performance, freedom from common interferences such as hematocrit and drugs, and elimination of operator technique and operator errors. StatStrip incorporates a patented, multi well technology that creates a new level of analytical performance for bedside glucose testing. StatStrip is the only meter and strip to actually measure and eliminate interferences from hematocrit and all electrochemical substances, including acetaminophen, ascorbic acid and uric acid. In addition StatStrip has no interference from maltose, galactose, xylose or oxygen. Over 35 hospital correlation and interference studies have validated StatStrip lab-like analytical performance across a wide glucose range of 10 to 600 g/dL StatStrip also eliminates calibration codes required of all other hospital meters. This eliminates an operator step and a source of operator error StatStrip lab-like analytical performance is coupled with the fastest analysis time, the smallest sample size of any hospital meter, plus many other excusive features for bedside glucose testing.
  7. The overwhelming volume of scientific papers, with experts all in agreement, validate StatStrip’s improved accuracy over competitive glucose monitors. These are just a few of the quotes taken from those papers that attest to StatStrip’s accuracy.