Point of Care Platelet/Thrombocyte Counter

Thrombocyte Platelet CounterPC100 – Platelet Counter

The PC100 Platelet Counter is a highly portable point-of-care device that accurately counts cells (platelets / thrombocytes) in minutes.

The automatic cell counter for thrombocytes or platelets is able to accurately count platelet concentrations in whole blood as well as in Platelet Rich Plasma (PRP). The platelet counter is a device which removes the need to count thrombocytes manually and is a cost effective, small and a flexible alternative to flow cytometers.

Smart Photonics

The measurement principle is based on patented optical imaging technology. All parts that come into contact with blood are disposable – no contamination, no cleaning time. The total blood sample preparation and automatic counting is typically done within 15 minutes.

Key features

  • Fast & Accurate
  • Accurate thrombocyte counting delivering counting results in minutes using only a minute drop of blood (20 microlitre) or PRP (10 Microlitre).
  • Validated for counting in whole blood and highly concentrated PRP.
 The PC100 platelet counter is sold by DutchMedicalDevices.
Regenerative medicine

The PC100 is a complete Counting solution

 

consisting of the counting device and disposable kit available for whole blood or PRP. disposable kit consists of biochemical reagent and disposable counting slides.

Point of care platelet Counting made easy

Make quality platelet counts with minimal training. Take a drop of blood or PRP. Prepare the sample. Fill the disposable slide, insert in the PC100 and press start. The smart algorithms fully automatically count and analyze the sample. Results are available within 8-15 min.

 
 
Automated platelet cell counter

Validated accuracy

The platelet counter PC100 is validated for human whole blood and PRP measurements. The validation ranges for whole blood are [20-600] and for PRP [250-3600] plt/nl. The accuracy is above 95%.
The validation was performed by Maastricht UMC+, Clinical Thrombosis & Hemostasis Department in the Netherlands.

 

Evaluation of the analytical performance

See publication in BMC Thrombosis Journal Published: 04 May 2021

How the PC100 is
Different From Others

The PC100 is the only validated point of care platelet counter that is truly easy to use with minimal training.

Fingerprick platelet blood test

Venous blood or fingerprick

The platelet counter PC100 is validated for use with venous blood. Also a comparison study was made between venous blood and fingerprick blood. The fingerprick method can be beneficial for certain applications as it is easier to perform, faster and less risk for infections. Contact 2M Engineering for further information.

 

Technical Specifications

PC100 Platelet Counter

  • Processing time (both chambers) : 8-15min
  • Device dimensions: 120 x 230 x 310mm (W x D x H)
  • Weight: 5kg
  • Power Supply (supplied):
    • Input: 100 to 240 VAC, 50Hz/60Hz
    • Output: 24 VDC, 2.5 A, EN60601 compliant

 

Certification: In Vitro Diagnostics Devices, non-Annex II List A and B in conformity with the Council Directive98/79/EC. In conformity with EN15223-1:2016, EN13612:2002, EN ISO18113-1:2011, EN ISO 18113-3:2011, EN61010-101:2002, EN61326-2-6:2006, EN62304:2006, EN 62366:2008 and 2011/65/EU.

PC100 Software & Computer

  • Analysis & user interface software runs on Windows 10 (64 bit) operating system, Installation executable supplied.

  • Computer (not supplied) recommended Intel i7, 2.4GHz, 8GB DRAM, 250GB SSD/HDD, 1 x USB2.0 + 1 x USB3.0 or 2 x USB3.0, Windows 10 (64bit)

Disposable kits

  • Single use counting slides with 2 counting chambers – coated glass
  • Eppendorf vials with reagent

Whole Blood Count

  • Color Eppendorf vials: clear
  • Measurement range: 20-600 platelets / nL
  • Sample size: 20μL
  • Dilution factor: 1 :25

Platelet Rich Plasma [PRP] Count

  • Color Eppendorf vials: green
  • Measurement range: 250-3500 platelets / nL
  • Sample size: 10μL
  • Dilution factor: 1 :100

Availability / sales

The PC100 is brought to market via Dutch Medical Devices BV [DMD] in the Netherlands. For more information or PC100 purchase visit the DMD website.

More information

About Dutch Medical Devices BV

Point of care diagnostic devices

Dutch Medical Devices [DMD] is a medtech company focused on point of care diagnostic devices. The company’s mission is to bring innovative Point of-Care diagnostic devices for biomarker measurement to market, making diagnosis and therapy faster, easier, more accessible, and more cost effective. DMD has a Quality Management System according to EN ISO 13485:2016

Platelet Counter

Make a platelet count in 4 steps

STEP 1 – TAKE BLOOD

Take a venous blood sample. 20μl of blood is sufficient for a whole blood measurement.

Take Blood for platelet Count

PREPARE PRP

Prepare PRP. 10μl of PRP is sufficient for a PRP measurement.

STEP 2- PREPARE SAMPLE

Use a pipette to add the blood sample or PRP to the reagent Eppendorf cup to lyse the red blood cells. Wait for 5 minutes.

Eppendorf vial for platelet count

STEP 3 – FILL SLIDE

Fill both chambers of the PC100 disposable counting slide using a pipette. Load the slide into the PC100 Platelet Counter. Start measurement.

Disposable counting chamber

STEP 4 – ANALYZE RESULTS

The PC100 Platelet Counter measures the concentration and reports the result in platelets/nl.

Analyze platelet count results

The PC100 against other methods

Flow Cytometers

The cost effective alternative

Flow cytometers are costly devices and need full cleaning after taking a sample. The complex fluid mechanics demands frequent cleaning and maintenance by a trained professional, which results in downtime and extra costs. Furthermore flow cytometers are more sensitive and need to be placed in a clean stable laboratory environment. The PC 100 can easily be transported and is less sensitive to be used in more demanding environments. All parts coming in contact with blood are only used once and then disposed. So no contamination  and no time consuming washing required.

Manual counting

More precise, faster, easier

The PC100 automated platelet cell counter makes counting platelets a up to 10x faster, easier and more accurate process compared to manual counting. Manually counting platelets must be performed by a trained professional and can be slow and tedious. The Platelet Counter makes it possible for anyone to quickly perform a simple count on a blood sample. The program calculates the cell count and concentration in just minutes. 

Measurement Results of the platelet/ thrombocyte counter

The automated platelet cell counter shows the measurement result in amount of platelets per nanoliter blood like 354 PLT/nl. For high-accuracy and measurement consistency the platelet concentration is determined at multiple locations. Cell images can immediately be viewed on screen. The images are in black and white with the counted platelets clearly marked in yellow.

Performance

Accuracy

Whole blood measurements

There is a close agreement between the quantified platelet values of PC100 and Sysmex XN9000 flow cytometer. Overall, the results of regression analysis showed that PC100 can count platelets of whole blood samples with an average bias (inaccuracy) of -3.362 (-2.312%) across the concentration range of 20-600 plt/nl. Accuracy is thus above 95%.

PRP measurements

There is close agreement between the quantified platelet values of the PC100 Platelet Counter and MUMC – Sysmex® XP-300 Automated Hematology System. Results of regression analysis showed that the PC100 Platelet Counter can quantify PRP platelets with an average bias (inaccuracy) of (2.0%) across the concentration range of 250-3600 platelet/nanolitre. Accuracy is thus above 95%.
 

Precision

Precision is a measure of closeness of agreement between quantified analyte values obtained by repeated measurements of the same sample/object under a specific set of conditions. Random error or imprecision is commonly expressed as the coefficient of variation (CV) calculated from the results of a set of duplicate measurements. Using duplicates for each sample, the CV% was calculated for the platelets of blood samples counted by PC100 over the concentration range of 20 to 600 plt/nl. The CV% (imprecision) varies with an average of 2.5% across the measurement range. This indicating that within the range of 20-600 plt/nl, the PC100 can count platelet of blood samples with an average precision of 97.5%. 

Validation

The platelet counter PC100 is validated for human whole blood and PRP measurements. The validation ranges for whole blood are [20-600] and for PRP [250-3600] plt/nl.

The validation was performed by Maastricht UMC+, Clinical Thrombosis & Hemostasis Department in the Netherlands.

 

Applications areas for the PC100 platelet counter

The platelet counter can offer quick insight in the exact platelet/thrombocyte concentration per nanolitre of whole blood or PRP.

Accurate platelet concentration is relevant in various regenerative applications.

These are examples for illustrative purposes.

PLATELET COUNTING IN VENOUS BLOOD AND PRP

The PC100 Platelet Counter is intended to count the number of platelets per nanolitre in venous whole blood (in EDTA) and PRP. The count is relevant for patients with bleeding disorders, blood disorders, bone marrow disorders and those undergoing chemotherapy.  The platelet count of PRP is relevant for regenerative applications.

FAST & EASY MEDICAL GRADE PLATELET COUNTING

Monitoring the number of platelets per nanolitre is relevant for these medical purposes. The user is a medical professional or working under the responsibility of a trained medical professional. The device is intended for a medical clinic or a doctor’s office, it is not intended for use in a home environment.

PLATELET COUNTING AT POINT OF CARE 

The platelet counter is positioned in line with major key trends on the medical (devices) market: a shift from second line care to first line care closer to the patient. By having count results instantly it has the potential to enable innovations in personalised medicine, reduce health care costs and the ability to measure in (remote) locations without well established medical infrastructure.

MAXILLOP-FACIAL SURGERY
Jaw reconstructions – sinus lifting – tooth extractions – periodontology

ORTHOPEDIC SURGERY
Knee replacements – hip replacements – shoulder replacements – bone reconstruction – spinal fusion – achilles rupture

PLASTIC SURGERY
Facelift – abdominoplasty

WOUND CARE
Tissue healing

SPORTS MEDICINE
Tendinopathies

CARDIAC SURGERY
Sternum closure – (leg) wound closure

TRAUMATOLOGY
Reconstructive surgeries

GENERAL SURGERY
Hernioplasty – vascular

EYE SURGERY
Macula degeneration

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