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IVD Manufacturer Data

  • The most knowledgeable source of information on instrument performance and likely effects of possible interferences with an HBOC is the IVD manufacturer of your laboratory instrument. The manufacturer should be contacted via its Technical Service Department.
  • Some IVD instrument manufacturers have presented or published results from investigations of possible interferences with Hemopure, Oxyglobin or both. The following IVD manufacturers are especially likely to have interference data:

 

IVD equipment manufacturer
(Click for contact information) 		Instrument model
(Click for data) 		Equipment type

Bayer HealthCare Diagnostics Division Tarrytown, NY

Advia 120

Hematology

Beckman Coulter

Brea, CA

Synchron CX7

Chemistry

Dade-Behring

Newark, DE

Dimension RxL Max
Dimension Xpand 		Immunochemistry & Chemisty;
Chemistry

Instrumentation Laboratory

Lexington, MA

GEM Premier 3000

Synthesis

Point-of-care;

Critical Care

Abbot Point of Care (i-Stat)

East Windsor, NJ

CG8+, EC8+, CG4+, Crea Cartridges

Point-of-care

Ortho-Clinical Diagnostics

Rochester, NY

VITROS Microslide,

VITROS ECi Immunodiagnostic,

VITROS MicroTip assay

Chemistry,

Immunodiagnostic, Chemistry

Roche Diagnostics

Tutzing, Germany

Cobas Integra 700

Hitachi 917

Chemistry

 

Hemopure Interference Testing Performed by IVD Manufacturer or Contract Laboratory

i-STAT System® Assay Limitations with Hemopure

i-STAT System Whole Blood Interference Limits for Hemopure.#

Hemopure interferences on whole blood measurements made on the i-STAT System have been investigated using CG8+, EC8+, CG4+ and CREA cartridges to determine the maximum whole blood concentration of Hemopure (g/dL) that can be tolerated for individual assays. Assay results should be comparable across all relevant i-STAT cartridges types.

Analyte

Maximal Allowable Hemopure Concentration (g/dL)

Blood urea nitrogen (BUN)

6.5

Calcium, ionized

6.5

Chloride

6.5

Creatinine

3.9

Glucose

6.5

Hematocrit

5.2

Calculated Hemoglobin[*]

0

pCO2

6.5

pH

6.5

pO2

6.5

Lactate

5.2

Potassium

6.5

Sodium

6.5

#This report reflects a joint study commissioned by OPK Biotech and executed with the support of i-STAT (Abbott Point of Care). This should not be perceived as a marketing claim or a claim regarding performance of Abbott Point of Care.


[*]Hemoglobin, in g dL-1, is calculated by multiplying the measured hematocrit value, in %PCV, by 0.34.

 

Dade Behring HBOC-201 Interference Results

Interferences have been tested on the Dade Behring Dimension® Xpand® and Dade Behring Dimension® RxL Max® systems spiked with HBOC-201 concentrations ranging between 0 and 6.4 g/dL.

 

When the Dade Behring Dimension® Xpand® and Dimension® RxL Max® are operated using Dade Behring products and according to the manufacturer's instructions, the following results were observed. Since HBOC-201 concentrations were tested up to an upper limit of 6.4 g/dL, patient samples with a Hemopure concentration above this concentration should not be analyzed for these assays due to unknown interference.

 

Dimension® Xpand® and Dimension RxL Max® Systems

 

Analyte

HBOC-201 (g/dL) above which assay results are inaccurate or interference unknown

Comments

Na

ok to 6.4

NA results decrease by about 1 mmol/L per 1 g/dL HBOC-201

K

ok to 6.4

K results decrease by about 0.03 mmol/L per 1 g/dL HBOC-201

Cl

ok to 3.3

CL results decrease by about 1.5 mmol/L per 1 g/dL HBOC-201

ECO2

ok to 0.1

ECO2 results decrease, Absorbance error over 3 g/dL HBOC-201

BUN

ok to 6.4

BUN results increase slightly by about 0.2 mg/dL per 1 g/dL HBOC-201

CREA

ok to 0.3 at 2.0 mg/dL CREA

or 0.8 at 6.0 mg/dL CREA

CREA results decrease by 0.7 mg/dL per 1 g/dL HBOC-201

GLU

ok to 0.8 at 75 mg/dL GLU

or 2.5 at 240 mg/dL GLU

GLU results decrease by about 10 mg/dL per 1 g/dL HBOC-201

CA

ok to 2.0

CA results increase by 0.3 mg/dL per 1 g/dL HBOC-201

PHOS

ok to 2.0

PHOS results increase, and may have Abnormal Assay error code above 3 g/dL of HBOC-201

MG

ok to 6.5

MG results stable within the larger of 0.2 mg/dL or 10%

TP

ok to 0.5

TP results Increased about 0.6 g/dL per 1 g/dL HBOC-201

ALB

ok to 2.5

ALB results lowered about 0.7 g/dL at 6.5 g/dL HBOC-201

URCA

ok to 0.5

URCA results with HBOC-201 over 1 g/dL have absorbance error flag

TBIL

ok to 0.4

TBIL results with HBOC-201 over 0.5 g/dL have hemoglobin error flag

DBIL

ok to <0.1

DBIL result decreases about 0.2mg/dL for each 1 g/dL of HBOC-201, have hemoglobin error over 0.5 g/dL HBOC-201

CHOL

ok to 1.3 at 100 mg/dL CHOL

or 2.0 at 200 mg/dL CHOL

CHOL result decreases about 8 mg/dL for each 1 g/dL of HBOC-201

AHDL

ok to 0.7

AHDL result decreases about 12% for each 1 g/dL of HBOC-201

TGL

ok to 0.2 at 50 mg/dL TGL

or 0.7 at 130 mg/dL TGL

TGL result increases about 20 mg/dL for each 1 g/dL of HBOC-201

AST

ok to 0.5

Error code with erroneous results

ALT

ok to 0.5

Error code with erroneous results

ALP

ok to 1.0

Error code with erroneous results

AMY

ok to 1.0

Error code with most erroneous results

CK

ok to 0.1 g/dL at 100 U/L CK

or 0.5 g/dL at 350 U/ L CK

HBOC-201 over 1 g/dL substantially increases CK results

LDH

ok to 2.0

HBOC-201 over 2 g/dL decreases LDH results

GGT

ok to 0.5

Error code with erroneous results

MMB

ok to 5.0

-

MYO

ok to 6.5

-

CTNI

ok to 4.0

CTNI results increase about 2% per 1 g/dL HBOC-201

 

About HBOCLab

HBOC Lab is presented by OPK Biotech.

HBOC Lab's goal is to provide clinical laboratories with guidelines and information for determining laboratory interferences that may occur in the presence of OPK Biotech's oxygen therapeutics (Hemopure, Oxyglobin).


OPK Biotech

11 Hurley Street
Cambridge, MA 02141
Tel: 617.234.6500
hboclabsupport@opkbiotech.com