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Helena Laboratories Point of Care

1530 Lindbergh Dr.

PO Box 752

Beaumont, TX 77704-0752

1-800-231-5663

Contact helena@helena.com for more information

www.helena.com I www.helenapoc.com 

Corporate Description

Established in 1967, Helena Laboratories is a premier manufacturer of diagnostic test kits and clinical laboratory instrumentation. Product lines include the clinical electrophoresis and hemostasis as well as Cascade POC Whole Blood Coagulation System, Plateletworks Bedside Platelet Aggregation, Actalyke Activated Clotting Time Testing, ColoScreen and ColoCARE occult blood products plus new HemoHeel Self-Actuating Incision Devices.

The Cascade POC analyzer offers a wide range of hemostasis assays at the lowest cost per test. Cascade POC uses unique encoded assay cards with a dry chemistry reagent system to monitor routine anticoagulants as wells as antithrombotic drugs. The Plateletworks™ platelet aggregation system provides platelet count, platelet aggregation or inhibition and CBC data in less than 5 minutes using whole blood at the point of care. The Actalyke® family of activated activated clotting time analyzers is well known for their dual clot detection, sensitivity and accuracy. A full line of ACT reagents are available, including highest sensitivity MAX-ACT™ blended reagent tubes.

 

Helena is also a world leader in fecal occult blood testing products, including ColoScreen-ES, traditional guaiac slides and ColoCARE at home occult blood tests. Helena’s corporate headquarters are in Beaumont, Texas with subsidiaries and distributors worldwide.

Products

 

Cascade® POC Analyzer

 

 

 

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Model Name

Cat. No. 5810

CLIA Classification

Non-waived

Size and Weight

6.0 x 3.9 x 10.5”, 4.25 lbs.

Data Transfer Capability

RS232, Printer

Features

Reaction chamber built into test card; Test type, lot number, and calibration information read directly from cards; Easy and affordable; Only 35 µL of sample required; Internal battery for bedside portability; Biologic and electronic QC with lockout, Operator and patient ID entry, NCCCLS POCT 1-A, CSA and CE compliant

Test Menu (Analytes that can be performed on instrument)

ACT, PT, aPTT

CPT code for each analyte

85347 ACT, 85610 PT, 85730 aPTT

Test Methodology

Photomechanical (Test Card)

Units in which the test result is reported

Clotting time in seconds, INR


C-ACT Test Cards (Celite Activator)

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CLIA Classification

Non-waived

Analytes performed on this device

Activated Clotting Time

CPT Code associated with each analyte

85347

Test methodology

Photomechanical (Test Card)

Sample volume

35 µL

Time to result

Within minutes

Units in which the test is reported

Seconds


PT-WB and PT-C Test Cards (ISI~1.0)

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CLIA Classification

Non-waived

Analytes performed on this device

Prothrombin Time

CPT Code associated with each analyte

85610

Test methodology

Photomechanical (Test Card)

Sample volume

35 µL

Time to result

Within minutes

Units in which the test is reported

Seconds, INR


aPTT Test Cards (citrated WB or Plasma)

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CLIA Classification

Non-waived

Analytes performed on this device

Activated Partial Thromboplastin Time

CPT Code associated with each analyte

85730

Test methodology

Photomechanical (Test Card)

Sample volume

35 µL

Time to result

Within minutes

Units in which the test is reported

Seconds


Plateletworks Collagen Kit

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CLIA Classification

Non-waived

Analytes performed on this device

Platelet Aggregation – Collagen Agonist

CPT Code associated with each analyte

85576

Test methodology

Electronic Impedance Measurement

Sample volume

1 mL whole blood

Time to result

Within minutes

Units in which the test is reported

Platelet Count (x103 cells/µL);%-Platelet Inhibition, %-Platelet Aggregation


Plateletworks ADP Kit

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CLIA Classification

Non-waived

Analytes performed on this device

Platelet Aggregation – ADP Agonist

CPT Code associated with each analyte

85576

Test methodology

Electronic Impedance Measurement

Sample volume

1 mL whole blood

Time to result

Within minutes

Units in which the test is reported

Platelet Count (x103 cells/µL);
%-Platelet Inhibition, %-Platelet Aggregation


ICHOR Hematology Analyzer

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Model Name

ICHOR/MICROS 60

CLIA Classification

Non-waived

Size and Weight

16.5" H x 12.5" W x 14" D; 30.8 lbs.

Data Transfer Capability

RS232, Printed results

Features

All-in-one reagent/wast pack; Automated closed tube sampling; Integrated QC program; Programmable high and low limits for each parameter; Push button standby and shut down cycle

Test Menu (Analytes that can be performed on instrument)

Platelet Aggregation (with ADP or Collagen Kit), Platelet Count, CBC

CPT code for each analyte

85576

Test Methodology

Electronic Impedance Measurement

Units in which the test result is reported

Platelet Count (x103 cells/mL); %-Platelet Inhibition,
%-Platelet Aggregation WBC (x103 cells/mL), RBC (x106 cells/mL); Hemoglobin (g/dL), Hematocrit (%)


MAX-ACT Tubes (Multiple activators – kaolin, celite and glass beads)

CLIA Classification

Non-waived

Analytes performed on this device

Activated Clotting Time

CPT Code associated with each analyte

85347

Test methodology

Electromagnetic Clot Detection (tube)

Sample volume

0.5 mL

Time to result

Within minutes

Units in which the test is reported

Seconds


Actalyke Reagent Tubes for Activated Clotting Times

C-ACT Tubes (Celite Activator)

K-ACT Tubes (Kaolin Activator)

 

G-ACT Tubes (Glass Bead Activator)

 

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CLIA Classification

Non-waived

Analytes performed on this device

Activated Clotting Time

CPT Code associated with each analyte

85347

Test methodology

Electromagnetic Clot Detection (tube)

Sample volume

0.4 - 2 mL

Time to result

Within minutes

Units in which the test is reported

Seconds


Actalyke® XL ACT Analyzer

 

 

 

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Model Name

Cat. No. 5770

CLIA Classification (Waived, Moderately complex)

Moderately Complex

Size and Weight

10.5 x 8 x 12”, 15 lbs.

Data Transfer Capability

3.5” Diskette, RS232, RF Transmit, Printer

Features

Dual wells, Auto start with tube insertion, Automatic tube type detector, 2-Point clot detection, Dual temperature monitor, Touch screen, QC record and LJ displays and print, Patient storage and transfer on diskette, QC lockout, Optional bar code reader for patient ID entry, 3 user security levels, Battery operation, NCCCLS POCT 1-A, CSA and CE compliant

Test Menu (Analytes that can be performed on instrument)

Activated Clotting Time - any ACT reagent tube

CPT code for each analyte

85347

Test Methodology

Electromagnetic Clot Detection (Tube)

Units in which the test result is reported

Seconds


Actalyke® Mini ACT Analyzer

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Model Name

Cat. No. 5753, 5755 (no printer)

CLIA Classification

Non-waived

Size and Weight

6.1 x 4.8 x 6.3”, 5.3 lbs.

Data Transfer Capability

RS232, Optional printer

Features

Single well, 2-point clot detection, Single button operation, High visibility display, Small 6” footprint, Inexpensive

Test Menu (Analytes that can be performed on instrument)

Activated Clotting Time - any ACT reagent tube

CPT code for each analyte

85347

Test Methodology

Electromagnetic Clot Detection (Tube)

Units in which the test result is reported

Seconds


ColoScreen®-ES

 

 

 

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CLIA Classification

Waived

Analytes performed on this device

Fecal Occult Blood Testing

CPT Code associated with each analyte

82270

Test methodology

Guaiac-based, enhanced sensitivity

Sample volume

Fecal smear

Time to result

1 minute

Units in which the test is reported

Positive or negative

Other

The ColoScreen-ES guaiac test provides enhanced sensitivity to blood in the stool. Intense blue color development makes it easy to interpret results.


ColoCare®

 

 

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CLIA Classification

Waived

Analytes performed on this device

Fecal Occult Blood Testing

CPT Code associated with each analyte

82270

Test methodology

Guaiac-based, enhanced sensitivity

Sample volume

After a bowel movement, the user places the ColoCARE in the toilet, watches for a color change, then flushes the pad away.

Time to result

1 minute

Units in which the test is reported

Positive or negative

Other

ColoCARE improves testing compliance by eliminating the unpleasant aspects of occult blood testing.

  • High patient compliance  

  • No stool handling 

  • No laboratory processing

Last updated: 02/16/2010 Questions or corrections: My Point of Care.net.© 2008 Medical Automation Systems, Inc. Legal Notice.
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