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Lab Director Information
- The information below is similar to Existing Data - Clinical Trial Information but provides more detail.
- ONLY if IVD manufacturer data is unavailable (see IVD Manufacturer Data), should the Hospital Laboratory Director make the decision to consider using the information from interference studies summarized from previous Hemopure clinical trials as a guideline for determining whether or not to report an assay result from a patient sample containing Hemopure.
- The Assay Limitation tables that are provided are summary results; individual instrument and site results varied.
- Data were compiled from 1994 to 2006 using triplicate samples of a known analyte concentration containing from zero to either 5.0 g/dL or 6.5 g/dL Hemopure.
- A high and low clinically relevant analyte concentration was used in most interference tests conducted.
- CLIA '88 and CAP criterions for acceptable error are provided in the Table: Acceptability recovery criterions below. However the criteria for acceptable error at individual clinical trial sites was determined by the laboratory directors or principal investigators at each site. Thus, acceptable concentrations of HBOC for reporting a result will vary depending on the criteria for acceptable error at each site - even when the same method is used.
- No control was exerted to standardize the method used on these instruments: instrument Standard Operating Procedures as well as the type of reagent may have differed between testing sites.
- For each instrument, the maximum plasma Hemopure concentration that would allow reporting of results for a particular test on a particular instrument is provided as either mean±Std Dev or median with minimum and maximum ranges from the different clinical trial sites.
- Click on the instrument of interest in the below Table to go to the Assay Limitation Summary for that instrument.
Listing of Assay Limitation Tables Available from Clinical Laboratory Testing
|
Assay Type |
IVD Manufacturer |
Instrument |
|
Blood Gas |
Radiometer |
|
|
Cardiac Markers |
Abbott |
|
|
Cardiac Markers |
Bayer |
|
|
Cardiac Markers |
Roche |
|
|
Cardiac Markers |
Various |
|
|
Chemistry |
Beckman |
|
|
Chemistry |
Dade Behring |
|
|
Chemistry |
Ortho-Clinical Diagnostics |
|
|
Chemistry |
Roche |
|
|
Coagulation |
Diagnostica |
|
|
Coagulation |
Fibrometer |
|
|
Coagulation |
IL |
|
|
Coagulation |
MDA |
|
|
Coagulation |
Sysmex |
|
|
Therapeutic Drugs |
Abbott |
|
|
Therapeutic Drugs |
Abbott |
Table: Acceptability recovery criterions.
Since the clinical in-house Hemopure testing began in 1995, the acceptable recovery ranges for a particular analyte varied slightly from site to site as they were at the discretion of the site's Laboratory Director. The values below represent acceptable recovery as stated by CLIA '88 and CAP guidelines.
|
Analyte |
Acceptable Error (±) |
|
ALT |
20% |
|
ALBUMIN |
10% |
|
ALK PHOS |
30% |
|
AMYLASE |
30% |
|
AST |
20% |
|
BUN (UREA) |
2 mg/dL or 9% (whichever is greater) |
|
BILI, TOTAL |
0.4 mg/dL or 20% (whichever is greater) |
|
BILI, CONJUGATED (DIRECT) |
0.4 mg/dL or 20% (whichever is greater) |
|
CALCIUM |
1.0 mg/dL |
|
CHLORIDE |
5% |
|
CHOLESTEROL |
10% |
|
CK-MB |
20% |
|
CK, TOTAL |
30% |
|
CREATININE |
0.3 mg/dL or 15% (whichever is greater) |
|
GGT |
15% |
|
GLUCOSE |
6.0 mg/dL or 10% (whichever is greater) |
|
LDH |
20% |
|
LACTATE |
15% |
|
LIPASE |
30% |
|
MAGNESIUM |
25% |
|
PHOSPHOROUS |
0.75 mg/dL |
|
POTASSIUM |
0.5 mmol/L |
|
SODIUM |
4.0 mmol/L |
|
TOTAL PROTEIN |
10% |
|
TROPONIN I (low target ~0.1 ug/L) |
0.05 ng/mL |
|
TROPONIN I (high target ~1.5 g/L) |
0.5 ng/mL |
|
URIC ACID |
17% |
Informational Results from Laboratory Testing for Hemopure Interferences.
Instruments: Radiometer (ABL 505, 700, 725, EML 100)
Maximum allowable Hemopure concentration (g/dL) for acceptable results. Concentrations of Hemopure greater than these amounts will affect the assay such that result will be outside of acceptable recovery limits.
|
Analyte |
Mean |
Median |
Std Dev |
Min |
Max |
Number Instruments Tested |
|
Calcium (Ionized) |
4.7 |
6.5 |
2.3 |
1.5 |
6.6 |
7 |
|
Chloride |
3.0 |
2.5 |
1.8 |
1.2 |
6.6 |
6 |
|
Glucose |
2.5 |
2.5 |
0.0 |
2.5 |
2.5 |
2 |
|
Lactate |
0.9 |
1.0 |
0.8 |
0.0 |
1.5 |
4 |
|
pCO2 |
4.5 |
4.5 |
2.8 |
2.5 |
6.6 |
2 |
|
pH |
2.0 |
2.0 |
0.7 |
1.5 |
2.5 |
2 |
|
pO2 |
1.3 |
1.3 |
1.8 |
0.0 |
2.5 |
2 |
|
Potassium |
3.6 |
2.5 |
1.7 |
2.5 |
6.6 |
5 |
|
Sodium |
3.9 |
2.5 |
2.1 |
2.5 |
6.6 |
6 |
The data was collected from 1996 to 2005.
Instrument: Abbott AxSYM
Maximum allowable Hemopure concentration (g/dL) for acceptable results. Concentrations of Hemopure greater than these amounts will affect the assay such that result will be outside of acceptable recovery limits.
|
Analyte |
Mean |
Median |
Std Dev |
Min |
Max |
Number Instruments Tested |
|
CK MB |
6.0 |
6.5 |
1.5 |
0.0 |
6.5 |
41 |
|
Troponin I |
5.4 |
6.5 |
1.9 |
1.3 |
6.5 |
20 |
The data was collected from 1996 to 2005.
Instrument: Bayer Centaur
Maximum allowable Hemopure concentration (g/dL) for acceptable results. Concentrations of Hemopure greater than these amounts will affect the assay such that result will be outside of acceptable recovery limits.
|
Analyte |
Mean |
Median |
Std Dev |
Min |
Max |
Number Instruments Tested |
|
CK-MB |
1.5 |
0.6 |
2.4 |
0.0 |
5.0 |
4 |
|
Troponin I |
2.7 |
1.2 |
3.3 |
0.5 |
6.5 |
3 |
The data was collected from 2000 to 2006.
Instrument: Roche Elecsys
Maximum allowable Hemopure concentration (g/dL) for acceptable results. Concentrations of Hemopure greater than these amounts will affect the assay such that result will be outside of acceptable recovery limits.
|
Analyte |
Mean |
Median |
Std Dev |
Min |
Max |
Number Instruments Tested |
|
CK-MB |
4.6 |
4.7 |
1.8 |
1.1 |
6.5 |
20 |
|
Troponin T |
4.3 |
4.7 |
2.2 |
0.4 |
6.5 |
22 |
The data was collected from 1998 to 2007.
Assays: Cardiac Markers
Instruments: Various
Title: Interference and Precision Studies of OPK Biotech's Hemopure (HBOC-201) on Commercial Cardiac Troponin Assays
Investigators: M.M. Murakami, H.E. Quist, F.S. Apple
Laboratory: Hennepin County Medical Center, Minneapolis, MN
Abstract: OPK Biotech Corporation has introduced the drug Hemopure (HBOC-201), an intravenous administered hemoglobin-based oxygen therapeutic to deliver oxygen to the body's tissues. It has been approved in South Africa for treating adult surgical patients who are acutely anemic, eliminating, reducing or delaying the need for allogenic red blood cell transfusions. To assist in the process to address FDA queries regarding safety and efficacy as a potential indications in cardiovascular ischemia and out-of-hospital trauma, the purpose of this study was to evaluate whether HBOC-201 interferes with the measurement of cardiac troponin; the standard biomarker for detection of myocardial injury. An interference study was conducted using NCCLS EP-7A guidelines. Three human plasma (heparin) pools based on cTnT concentrations (negative 0.0 ng/mL; medium 0.03 ng/mL; high 0.10 ng/mL) were spiked with varying concentrations of HBOC, ranging from 0.189 g/dL to 12.6 g/dL. The assays studied were: cTnI - Abbott Architect, Abbott i-STAT, Bayer Centaur, Beckman Access, Dade Behring Dimension, Ortho-Clinical Diagnostics Vitros ECi; cTnT - Roche Elecsys 2010. Each aliquot was measured twice with a negative control between each treated specimen. In phase I analytical interference, percent (%) recovery, and % cross-reactivity were evaluated. We observed acceptable recoveries, minimal interference and minimal cross-reactivity from HBOC, for concentration up to 12.6 g/dL, for the Abbott Architect cTnI, Dade cTnI, Beckman cTnI, and Roche cTnT assays. The Ortho, Bayer and i-STAT cTnI assays demonstrated poor recoveries and analytical interferences at HBOC concentrations as low as 0.63 g/dL. Percent cross reactivity was calculated for all pools and was negligible for all assays (<0.00001%).
|
Phase I |
Abbott Arch |
Abbott i-STAT |
Dade |
Bayer |
Beckman |
Ortho |
Roche |
|
% Recovery |
85-108 |
89-165 |
91-125 |
94-182 |
98-114 |
111-327 |
83-104 |
In phase II, a 10-day modified NCCLS precision study was carried out on the
assays not prone to HBOC interference, as identified in phase I. The Abbott
Architect, Beckman Access, Dade Dimension, and Roche Elecsys cTn assays
demonstrated excellent within-run and total precision, range 1.2 to 6.2 %CV, at
two HBOC concentrations of 6.3g/dL and 0.63g/dL. These observations were based
on using a cTnT-positive plasma pool with a cTnT concentration (0.36 ng/mL)
that would be indicative of myocardial injury. In conclusion, 4 cardiac
troponin assays were validated to be effective systems to accurately reflect
in-vivo myocardial injury, without suspect of interference, cross-reactivity
with or variability due to OPK Biotech's Hemopure HBOC-201 product.
(Provided, with consent, from Dr. Fred Apple, personal communication)
Assay: Chemistry
Instruments: Beckman Coulter (CX3, CX7, CX9, LX20, LXi)
Maximum allowable Hemopure concentration (g/dL) for acceptable results. Concentrations of Hemopure greater than these amounts will affect the assay such that result will be outside of acceptable recovery limits.
|
Analyte |
Mean |
Median |
Std Dev |
Min |
Max |
Number Instruments Tested |
|
Albumin |
0.3 |
0.0 |
0.7 |
0.0 |
2.0 |
9 |
|
Alkaline Phosphatase |
0.9 |
1.0 |
0.6 |
0.0 |
2.0 |
9 |
|
ALT |
0.7 |
0.5 |
0.7 |
0. 0 |
2.5 |
9 |
|
Amylase |
0.4 |
0.0 |
0.6 |
0.0 |
1.5 |
9 |
|
AST |
0.4 |
0.5 |
0.5 |
0.0 |
1.6 |
9 |
|
Bilirubin (Direct) |
0.0 |
0.0 |
0.1 |
0.0 |
0.1 |
7 |
|
Bilirubin (Total) |
0.1 |
0.0 |
0.2 |
0.0 |
0.4 |
8 |
|
BUN |
5.0 |
6.5 |
1.9 |
0.0 |
6.5 |
9 |
|
Calcium |
4.6 |
6.5 |
2.5 |
0.0 |
6.5 |
11 |
|
Chloride |
4.5 |
6.5 |
2.6 |
0.0 |
6.5 |
11 |
|
Cholesterol |
2.9 |
2.5 |
0.7 |
2.0 |
4.3 |
9 |
|
Creatine Kinase |
0.2 |
0.0 |
0.4 |
0.0 |
1.2 |
9 |
|
Creatinine (filtered) |
5.2 |
5.8 |
1.6 |
2.5 |
6.5 |
6 |
|
Creatinine (not filtered) |
1.7 |
1.5 |
0.8 |
1.0 |
2.6 |
3 |
|
CRP |
1.3 |
1.3 |
1.8 |
0.0 |
2.6 |
2 |
|
GGT |
0.4 |
0.3 |
0.5 |
0.0 |
1.5 |
9 |
|
Glucose |
3.9 |
4.5 |
2.2 |
1.5 |
6.5 |
9 |
|
Lactate |
0.8 |
0.8 |
1.1 |
0.0 |
1.5 |
2 |
|
LDH |
2.1 |
1.0 |
2.7 |
0.0 |
6.5 |
8 |
|
Lipase |
2.6 |
1.5 |
2.6 |
1.0 |
6.5 |
4 |
|
Magnesium |
1.2 |
0.5 |
2.0 |
0.0 |
6.5 |
10 |
|
Phosphorus |
0.8 |
0.5 |
1.3 |
0.0 |
4.5 |
10 |
|
Potassium |
4.4 |
5.0 |
2.5 |
0.0 |
6.5 |
11 |
|
Sodium |
4.4 |
5.0 |
2.5 |
0.1 |
6.5 |
11 |
|
Total Protein |
0.3 |
0.4 |
0.2 |
0.0 |
0.5 |
9 |
|
Triglycerides |
0.1 |
0.1 |
0.1 |
0.0 |
0.3 |
3 |
|
Uric Acid |
0.3 |
0.4 |
0.4 |
0.0 |
1.0 |
9 |
The data was collected from 2005 to 2006.
Instrument: Dade Behring Dimension (AR, XL, RXL)
Maximum allowable Hemopure concentration (g/dL) for acceptable results. Concentrations of Hemopure greater than these amounts will affect the assay such that result will be outside of acceptable recovery limits.
|
Analyte |
Mean |
Median |
Std Dev |
Min |
Max |
Number Instruments Tested |
|
Albumin |
0.8 |
0.0 |
1.3 |
0.0 |
4.0 |
10 |
|
Alkaline Phosphatase |
0.3 |
0.5 |
0.4 |
0.0 |
1.0 |
9 |
|
ALT |
0.7 |
0.6 |
0.2 |
0.5 |
1.0 |
10 |
|
Amylase |
1.5 |
1.5 |
0.4 |
0.5 |
2.0 |
9 |
|
AST |
0.9 |
1.0 |
0.2 |
0.5 |
1.0 |
10 |
|
Bilirubin (Direct) |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
7 |
|
Bilirubin (Indirect) |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
2 |
|
Bilirubin (Total) |
0.1 |
0.0 |
0.2 |
0.0 |
0.5 |
9 |
|
BUN |
5.4 |
5.0 |
0.8 |
4.5 |
6.5 |
9 |
|
Calcium |
4.2 |
4.5 |
1.6 |
0.0 |
5.0 |
9 |
|
Chloride |
5.9 |
6.5 |
0.8 |
5.0 |
6.5 |
8 |
|
Cholesterol |
2.3 |
2.0 |
0. 9 |
1.2 |
4.0 |
8 |
|
Creatine Kinase |
0.0 |
0.0 |
0.1 |
0.0 |
0.2 |
9 |
|
Creatinine (filtered) |
5.5 |
6.5 |
1.5 |
2.6 |
6.5 |
8 |
|
Creatinine (not filtered) |
1.9 |
1.5 |
2.1 |
0.0 |
6.5 |
7 |
|
GGT |
0.4 |
0.5 |
0.2 |
0.0 |
0.6 |
9 |
|
Glucose |
1.0 |
0.5 |
1.3 |
0.0 |
3.9 |
8 |
|
LDH |
4.4 |
4.5 |
0.5 |
4.0 |
5.0 |
9 |
|
Lipase |
3.5 |
2.5 |
2.7 |
1.5 |
6.5 |
3 |
|
Magnesium |
0.5 |
0.5 |
0.5 |
0.0 |
1.6 |
9 |
|
Phosphorus |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
9 |
|
Potassium |
6.0 |
6.5 |
0.8 |
5.0 |
6.5 |
9 |
|
Sodium |
6.0 |
6.5 |
0.8 |
5.0 |
6.5 |
9 |
|
Total Protein |
1.6 |
1.5 |
0.5 |
1.00 |
2.50 |
8 |
|
Uric Acid |
1.0 |
0.6 |
1.2 |
0.00 |
3.00 |
10 |
The data was collected from 1994 to 2000.
Instrument: Ortho-Clinical Diagnostics VITROS (250, 500, 700, 750, 950)
Maximum allowable Hemopure concentration (g/dL) for acceptable results. Concentrations of Hemopure greater than these amounts will affect the assay such that result will be outside of acceptable recovery limits.
|
Analyte |
Mean |
Median |
Std Dev |
Min |
Max |
Number Instruments Tested |
|
Albumin |
0.0 |
0.0 |
0.2 |
0.0 |
1.0 |
37 |
|
Alkaline Phosphatase |
0.0 |
0.0 |
0.0 |
0.0 |
0.2 |
36 |
|
ALT |
0.4 |
0.5 |
0.3 |
0.0 |
1.0 |
42 |
|
Amylase |
0.5 |
0.5 |
0.5 |
0.0 |
2.0 |
45 |
|
AST |
3.5 |
4.0 |
1.7 |
0.0 |
6.5 |
43 |
|
Bilirubin (Direct) |
0.1 |
0.0 |
0.4 |
0.0 |
1.5 |
21 |
|
Bilirubin (Indirect) |
0.6 |
0.0 |
1.9 |
0.0 |
6.5 |
20 |
|
Bilirubin (Total) |
0.1 |
0.0 |
0.2 |
0.0 |
1.0 |
39 |
|
BUN |
4.4 |
5.0 |
2.2 |
0.0 |
6.5 |
45 |
|
Calcium |
4.0 |
5.0 |
1.9 |
0.0 |
6.5 |
40 |
|
Chloride |
5.6 |
5.8 |
1.0 |
2.5 |
6.6 |
41 |
|
Cholesterol |
3.2 |
3.0 |
1.5 |
1.0 |
6.5 |
22 |
|
Creatine Kinase |
3.2 |
5.0 |
2.5 |
0.0 |
6.5 |
39 |
|
Creatinine (filtered) |
6.2 |
6.5 |
0.7 |
4.3 |
6.5 |
22 |
|
Creatinine (not filtered) |
1.5 |
1.8 |
0.6 |
0.0 |
4.0 |
33 |
|
GGT |
0.7 |
0.6 |
1.1 |
0.0 |
6.5 |
37 |
|
Glucose |
4.7 |
5.0 |
1.8 |
0.5 |
6.5 |
43 |
|
LDH |
0.2 |
0.0 |
0.4 |
0.0 |
1.6 |
39 |
|
Lipase |
4.9 |
5.0 |
1.3 |
1.5 |
6.5 |
45 |
|
Magnesium |
2.5 |
2.3 |
2.2 |
0.0 |
6.5 |
42 |
|
Phosphorus |
1.9 |
2.0 |
1.0 |
0.0 |
4.0 |
41 |
|
Potassium |
5.7 |
6.5 |
1.0 |
2.5 |
6.5 |
39 |
|
Sodium |
5.5 |
5.0 |
1.0 |
2.5 |
6.6 |
40 |
|
Total Protein |
0.1 |
0.0 |
0.2 |
0.0 |
0.5 |
41 |
|
Uric Acid |
3.9 |
5.0 |
1.7 |
0.0 |
6.5 |
39 |
The data was collected from 1996 to 2005.
Assay: Chemistry
Instrument: Roche Modular & Hitachi (917, 912, 911, 747)
Maximum allowable Hemopure concentration (g/dL) for acceptable results. Concentrations of Hemopure greater than these amounts will affect the assay such that result will be outside of acceptable recovery limits.
|
Analyte |
Mean |
Median |
Std Dev |
Min |
Max |
Number Instruments Tested |
|
Albumin |
0.2 |
0.3 |
0.2 |
0.0 |
0.5 |
17 |
|
Alkaline Phosphatase |
1.1 |
1.0 |
1.0 |
0.0 |
2.5 |
17 |
|
ALT |
3.6 |
3.9 |
1.5 |
1.2 |
6.5 |
18 |
|
Amylase |
1.8 |
1.2 |
1.4 |
0.5 |
5.0 |
17 |
|
AST |
3.3 |
2.5 |
2.1 |
0.4 |
6.5 |
18 |
|
Bilirubin (Direct) |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
14 |
|
Bilirubin (Total) |
0.5 |
0.0 |
1.0 |
0.0 |
2.5 |
18 |
|
BUN |
4.3 |
4.3 |
1.6 |
2.5 |
6.5 |
17 |
|
Calcium |
3.2 |
2.5 |
2.1 |
1.0 |
6.5 |
16 |
|
Chloride |
4.4 |
4.30 |
2.0 |
1.0 |
6.5 |
15 |
|
Cholesterol |
1.2 |
1.5 |
0.5 |
0.0 |
2.0 |
13 |
|
CO2 |
0.6 |
0.0 |
0.8 |
0.0 |
1.5 |
5 |
|
Creatine Kinase |
3.4 |
2.5 |
2.2 |
0.0 |
6.5 |
18 |
|
Creatinine (filtered) |
4.7 |
4.3 |
1.8 |
2.5 |
6.5 |
15 |
|
Creatinine (not filtered) |
0.1 |
0.0 |
0.1 |
0.0 |
0.3 |
10 |
|
CRP |
1.8 |
2.0 |
0.9 |
0.0 |
2.5 |
7 |
|
GGT |
0.7 |
0.1 |
0.8 |
0.0 |
2.0 |
14 |
|
Glucose |
4.5 |
4.3 |
2.0 |
0.5 |
6.5 |
17 |
|
HDL Cholesterol |
1.9 |
2.0 |
0.9 |
0.5 |
2.6 |
5 |
|
Lactate |
0.6 |
0.4 |
0.6 |
0.0 |
0.4 |
5 |
|
LDH |
2.6 |
2.5 |
1.8 |
0.5 |
6.5 |
17 |
|
LDL Cholesterol |
1.8 |
2.1 |
1.1 |
0.4 |
2.6 |
4 |
|
Magnesium |
1.7 |
1.8 |
1.4 |
0.0 |
5.0 |
14 |
|
Phosphorus |
2.2 |
1.0 |
2.5 |
0.0 |
6.5 |
17 |
|
Potassium |
4.4 |
4.3 |
1.9 |
1.5 |
6.5 |
15 |
|
Sodium |
4.6 |
4.3 |
1.8 |
2.5 |
6.5 |
15 |
|
Total Protein |
1.3 |
1.2 |
0.8 |
0.3 |
3.0 |
17 |
|
Triglycerides |
0.2 |
0.3 |
0.2 |
0.0 |
0.5 |
5 |
|
Uric Acid |
0.31 |
0.3 |
0.3 |
0.0 |
1.0 |
14 |
The data was collected from 1999 to 2005.
Instruments: Diagnostica Stago
Maximum allowable Hemopure concentration (g/dL) for acceptable results. Concentrations of Hemopure greater than these amounts will affect the assay such that result will be outside of acceptable recovery limits.
|
Analyte |
Mean |
Median |
Std Dev |
Min |
Max |
Number Instruments Tested |
|
aPTT |
4.7 |
5.0 |
2.1 |
0.0 |
6.5 |
18 |
|
D-Dimer |
0.9 |
0.9 |
1.3 |
0.0 |
1.8 |
2 |
|
Fibrinogen |
4.4 |
5.1 |
2.3 |
0.0 |
6.5 |
21 |
|
PT(INR) |
4.6 |
5.0 |
1.8 |
1.3 |
6.5 |
24 |
The data was collected from 1996 to 2005.
Assay: Coagulation
Maximum allowable Hemopure concentration (g/dL) for acceptable results. Concentrations of Hemopure greater than these amounts will affect the assay such that result will be outside of acceptable recovery limits.
|
Analyte |
Mean |
Median |
Std Dev |
Min |
Max |
Number Instruments Tested |
|
aPTT |
4.5 |
5.0 |
2.0 |
0.7 |
6.5 |
29 |
|
Fibrinogen |
5.0 |
6.5 |
2.0 |
0.0 |
6.5 |
26 |
|
PT(INR) |
5.6 |
6.5 |
1.6 |
0.0 |
6.5 |
29 |
The data was collected from 1994 to 2005.
Instrument: IL ACL (100, 200, 3000, 7000, Future +)
Maximum allowable Hemopure concentration (g/dL) for acceptable results. Concentrations of Hemopure greater than these amounts will affect the assay such that result will be outside of acceptable recovery limits.
|
Analyte |
Mean |
Median |
Std Dev |
Min |
Max |
Number Instruments Tested |
|
aPTT |
4.2 |
3.9 |
2.0 |
0.7 |
6.5 |
27 |
|
Fibrinogen |
1.5 |
0.7 |
1.9 |
0.0 |
3.9 |
27 |
|
PT(INR) |
4.3 |
4.5 |
2.2 |
0.0 |
6.5 |
26 |
The data was collected from 1997 to 2005.
Assay: Coagulation
Instruments: Sysmex (1000, 1500, 6000, 7000)
Maximum allowable Hemopure concentration (g/dL) for acceptable results. Concentrations of Hemopure greater than these amounts will affect the assay such that result will be outside of acceptable recovery limits.
|
Analyte |
Mean |
Median |
Std Dev |
Min |
Max |
Number Instruments Tested |
|
aPTT |
4.3 |
4.7 |
2.0 |
1.2 |
6.5 |
14 |
|
Fibrinogen |
4.0 |
4.7 |
2.4 |
0.0 |
6.5 |
14 |
|
PT(INR) |
4.7 |
4.7 |
1.4 |
2.5 |
6.5 |
14 |
The data was collected from 1996 to 2006
Instrument: MDA 180
Maximum allowable Hemopure concentration (g/dL) for acceptable results. Concentrations of Hemopure greater than these amounts will affect the assay such that result will be outside of acceptable recovery limits.
|
Analyte |
Mean |
Median |
Std Dev |
Min |
Max |
Number |
|
aPTT |
3.6 |
3.3 |
1.9 |
1.3 |
6.5 |
10 |
|
Fibrinogen |
0.1 |
0.0 |
0.4 |
0.0 |
1.3 |
9 |
|
PT(INR) |
3.6 |
3.9 |
0.8 |
2.6 |
5.0 |
9 |
The data was collected from 1995 to 2000.
Assay: Therapeutic Drugs
Maximum allowable Hemopure concentration (g/dL) for acceptable results. Concentrations of Hemopure greater than these amounts will affect the assay such that result will be outside of acceptable recovery limits.
|
Analyte |
Mean |
Median |
Std Dev |
Min |
Max |
Number Instruments Tested |
|
Digoxin |
5.2 |
5.0 |
1.8 |
0.0 |
6.5 |
13 |
|
Gentamicin |
1.7 |
1.0 |
2.2 |
0.0 |
6.5 |
14 |
|
NAPA |
3.6 |
5.0 |
2.4 |
0.0 |
6.5 |
7 |
|
Phenytoin |
5.8 |
5.8 |
0.8 |
5.0 |
6.5 |
6 |
|
Procainamide |
4.3 |
5. 0 |
1.8 |
1.0 |
6.5 |
8 |
|
Quinidine |
2.9 |
2.8 |
2.1 |
0.0 |
5.0 |
8 |
|
Theophylline |
5.2 |
5.0 |
1.2 |
3.0 |
6.5 |
9 |
|
Vancomycin |
3.9 |
5.0 |
2.7 |
0.0 |
6.5 |
15 |
The data was collected from 1996 to 2005.
Assay: Therapeutic Drugs
Maximum allowable Hemopure concentration (g/dL) for acceptable results. Concentrations of Hemopure greater than these amounts will affect the assay such that result will be outside of acceptable recovery limits.
|
Analyte |
Mean |
Median |
Std Dev |
Min |
Max |
Number Instruments Tested |
|
Amikacin |
2.5 |
2.5 |
0.0 |
2.5 |
2.5 |
2 |
|
Digoxin |
2.8 |
3.0 |
2.2 |