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CapitainerModel B10 - Microsampling Card

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The Capitainer B10 is an advanced microsampling card designed for efficient blood sample collection. It provides a precise solution for at-home sampling, aiding healthcare providers, researchers, and laboratories in obtaining accurate blood samples for analysis. The device automatically meters 2×10µl of blood, ensuring reliability by eliminating over- or under-fill risks. Its design features a built-in indicator confirming successful sampling, with samples protected from contamination. The device offers user-friendliness by requiring just one drop of blood. Innovatively, it utilizes microfluidic technology to deliver a consistent sample volume, which helps overcome traditional issues related to hematocrit variation, enabling the use of the full sample volume for quantitative analysis. Constructed mainly of paper with minimal plastic, the card operates efficiently in a wide range of temperatures and humidity. It is CE-IVD registered and FDA registered as a Class 1 device for specified regions, emphasizing its regulatory compliance.

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Capitainer B10 (formerly known as Capitainer®qDBS) is the next generation dried blood spot microsampling card based on our technology. It empowers healthcare providers, researchers and laboratories across the world to provide accurate and easy to use at-home sampling solutions for their customers and patients.

Size
Product dimensions: 78 x 43 x 3 mm
Sample disc diameter: 6 mm
Sample volume: 2 x 10 µl

Material
Paper: Ahlstrom grade 222
80% of the device is paper based
< 1.2 grams of plastics per device

Accuracy
Reproducibility:
Better than 0.5 μl as one Standard deviation (SD), (CV < 5%)
Outliers:
Rate of over- or under-sampling (with a deviation > 3 SD) < 0.1%
Non-sampling: < 5%

Operating Conditions
Temperature range: +15°C to +35°C
Relative humidity range: 15% to 90%
Hematocrit value: 25% to 55%
The card must be used within 30 minutes from opening the package

Sample Storage
Collected samples can be stored at room temperature.
The stability of individual analytes in samples should be validated by the responsible laboratory. In general, stability increases with lower temperature and lower humidity. Our discs can be stored in the freezer to extend stability. Please refer to the extensive literature for traditional samples as guidance for individual analytes.

Disposal
Dispose according to local regulations. Take care with blood stained materials and sharps.

Regulatory
Capitainer®B10 is a CE-IVD (IVDR) product registered according to the IVD Regulation (EU) 2017/746. The product is registered with FDA as a Device Class 1. In other regions, where above registrations does not apply, the device is supplied as a research use only (RUO) product for research and non-diagnostic activities. End-users and laboratories are responsible for validating the assay results from Capitainer® products.