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

TEST KIT REQUIREMENTS: Plateletworks™ Platelet Aggregation

Plateletworks™ Collagen Kit

CLIA Classification (Waived, Moderately complex)	Moderately Complex
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

CLIA Classification (Waived, Moderately complex)	Moderately Complex
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

INSTRUMENT REQUIREMENTS: Plateletworks™ Platelet Aggregation

ICHOR Hematology Analyzer

Model Name	ICHOR/MICROS 60
CLIA Classification (Waived, Moderately complex)	Moderately Complex
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 (%)

TEST KIT REQUIREMENTS: Actalyke Activated Clotting Time

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

CLIA Classification (Waived, Moderately complex)	Moderately Complex
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

C-ACT Tubes (Celite Activator)
K-ACT Tubes (Kaolin Activator)
G-ACT Tubes (Glass Bead Activator)

CLIA Classification (Waived, Moderately complex)	Moderately Complex
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

INSTRUMENT REQUIREMENTS: Actalyke Activated Clotting Time

Actalyke® XL ACT Analyzer

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

Model Name	Cat. No. 5750, 5752 (no printer)
CLIA Classification (Waived, Moderately complex)	Moderately Complex
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

TEST KIT REQUIREMENTS: ColoScreen-ES Occult Blood

ColoScreen®-ES

CLIA Classification (Waived, Moderately complex)	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®

CLIA Classification (Waived, Moderately complex)	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

TEST KIT REQUIREMENTS: Triplett Incision Devices

Triplett® Bleeding Time Device

CLIA Classification (Waived, Moderately complex)	Moderately Complex
Analytes performed on this device	Bleeding Time Testing
CPT Code associated with each analyte	85002
Test methodology	5.0 x 1.0 mm surgical incision
Sample volume	Not applicable
Time to result	Within minutes
Units in which the test is reported	Minutes
Other	The Tip Tripper constant force device can be used with the Triplett to improve reproducibility by eliminating the tech-to-tech variability in pressure applied to the skin when triggering the incision device.