Point of Care Platelet/Thrombocyte Counter

Accurate & validated platelet counts in minutes

The PC100 Automated Platelet / Thrombocyte Cell Counter is a highly portable point-of-care device that accurately counts platelets or thrombocytes in whole blood as well as in Platelet Rich Plasma in minutes. The Automated Platelet Cell Counter is a medical device which removes the need to count Thrombocytes (platelets) manually.

Accurate counting from 20-4000 plt/nl

The platelet cell counter is able to accurately count platelet or thrombocytes concentrations in whole blood from very low levels (10 plts/nl) as well as in Platelet Rich Plasma up to 10x baseline. 

How the platelet / thrombocyte counter works

It uses optical technology to accurately and quickly count the number of platelets per nanoliter of blood from a patient. The platelet counter is connected to a normal laptop where the platelet counter software application runs that controls the platelet counter and does all the image processing.

Automated platelet cell counter
Disposable counting chamber for automated platelet cell counter
Platelet Counter
Biomarkers - Platelets as biomarkers for cardiovascular disease

Key features

  • Full platelet count including blood sample preparation typically within 15 minutes.
  • Highly accurate, reproducible and medically validated by Maastricht University Hospital
  • The device uses disposable counting slides which makes it fast, clean and accurate.
  • The platelet counter counts from 20 to 4000 platelets per nl in whole blood.
  • Only a tiny drop of blood is needed to make a measurement
  • Accuracy comparable with the best flow cytometers available.
Point of care cell counting

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 refilled 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 cost effective alternative to flow cytometers

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. The measurement principle is based on patented optical technology.

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. Automated Platelet Cell Counter - platelet count result

Quicker, Easier & More Precise

The 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. The Automatic Platelet Counter calculates cell count and concentration in just minutes.

Disposable Counting Chambers — No Washing or Contamination

The disposable counting slides consist of two independently enclosed chambers. Cell suspension of 10 microliters is loaded into the chamber using a supplied chamber filling capillary. The slide is inserted into the platelet counter and the cells are imaged. The slides and the capillaries are disposed of directly after use preventing contamination. A PC100 disposable kit contains Eppendorf vials with reagent 1:25 (480 μl) & disposable counting slides and is available for whole blood and PRP counts.

Applications areas for the platelet / thrombocyte counter

The number of platelets in your blood can be affected by many diseases such as HIV, Measles, and Tuberculosis. It can also be affected by conditions such as Anemia or even certain forms of cancer. It may be necessary to count platelets periodically to monitor or diagnose these conditions. If a patient’s concentration of platelets becomes too low (Thrombocytopenia) their risk of bleeding becomes very high. On the other hand if the number of platelets is too high (Thrombocytosis) blood clots are more likely to occur which can cause serious health issues.

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.

Certification

The PC100 Platelet Counter is a device intended by the manufacturer to be used in vitro for the examination of blood derived from the human body, and matches the definition of ‘in vitro diagnostic medical device’, falling within the scope of IVDD 98/79/EC. The PC100 is CE IVD certified and complies with all Medical guidelines and regulations.

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.

To ensure full system quality, the PC100 Platelet Counter has been manufactured by Dutch Medical Devices BV in compliance with the requirements of applicable regulatory standards. DMD has a Quality Management System according to EN ISO 13485:2016+AC:2016.

Purchase / distribution

The PC100 platelet counter is brought to market by Dutch Medical Devices B.V. For more device information, distribution possibilities or device purchase go to DutchMedicalDevices.com

Partners

Maastricht University Medical Centre, 2M Engineering

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