Point of Care Platelet/Thrombocyte Counter

Thrombocyte Platelet CounterPC100 – Platelet Counter

Fast & Accurate

Accurate thrombocyte counting delivering counting results in minutes using only a minute drop of blood (10-20 microlitre).

Validated for counting in whole blood and highly concentrated PRP.

Platelet Counter Point of Care Device

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. 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 platelet concentrations between 20-3500 plt/nl for counting in whole blood or Platelet Rich Plasma (PRP). The accuracy is above 95% with an average precision above 97.5% across the range of 20-600 plt/nl. The validation is executed by Maastricht UMC+, Clinical Thrombosis & Hemostasis in the Netherlands.

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.

Venous blood or finger prick

The platelet counter PC100 is validated for use with venous blood or finger prick blood as the device only requires a minute drop of blood (10-20μl). The benefit of the finger prick is that it is easier to perform, faster and less risk for infections.

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

  • Counting chamber: 2 covered chambers – coated glass
    Type: Whole Blood Count and PRP Count
  • Content: 100 Eppendorf cups with reagent, 100 counting slides

Whole Blood Count

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

Platelet Rich Plasma [PRP] Count

  • Color Eppendorf cups: 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+AC:2016

Platelet Counter

Make a platelet count in 4 steps

To make a platelet count  with the PC100 platelet / thrombocyte counter first take blood from the patient. Lyse the red blood cells in the blood sample using the Eppendorf cups prefilled with reagent from the disposable kit. Next, fill the disposable counting slide and insert the disposable slide in the platelet counter. Start the count with the PC100 software application from your computer, the results are shown on your screen in a couple of minutes.

STEP 1 – TAKE BLOOD

Take a venous blood sample. One drop of blood is in principle sufficient. Validation for capillary blood is still pending.

STEP 2- PREPARE SAMPLE

Use a manual pipette to add a blood sample to an Eppendorf cup filled with reagents to lyse the red blood cells. Wait for 5 minutes.

STEP 3 – FILL SLIDE

Fill both chambers of the PC100 disposable counting slide using a manual pipette. Insert the slide into the PC100 Platelet Counter.

STEP 4 – VIEW RESULTS

The PC100 Platelet Counter fully automatically processes the blood sample and reports back the count result in amount of plt/nl.

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

Accuracy is a measure of closeness of the agreement between the quantified analyte values obtained by the tested method/device and the true values of the gold reference method/device. Systematic error or inaccuracy is quantified by the average bias, which is usually expressed as the constant and proportional bias from a regression procedure. Following the CLSI EP9 method comparison guideline, the passing-bablok linear regression method was used to find the best mathematical fit between the quantified platelets obtained by PC100 and the gold reference device (MUMC). There is a close agreement between the quantified platelet values of PC100 and MUMC. Overall, the results of regression analysis showed that PC100 can count platelets of blood samples with an average bias (inaccuracy) of -3.362 (-2.312%) across the concentration range of 20-600 plt/nl.

Benchmark: Sysmex XN9000 flow cytometer.

 
 

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 20-600 plt/nl, which covers about 90% of all applications. For platelet concentrations above 600 plt/nl another reagent dilution is required (validation for higher concentrations is pending). The validation is executed by Maastricht UMC+, Clinical Thrombosis & Hemostasis in the Netherlands.

 

Applications areas for the PC100 platelet counter

The PC100 enables a wide variety of applications. These are examples for illustrative purposes.

PLATELET COUNTING IN VENOUS OR FINGER PRICK BLOOD

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

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. The cell concentration range evaluated by the device is [20-600] plt/nl.

PLATELET COUNTING AT HOME OR REMOTE AREAS

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 / home. 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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