Capitainer®SEP10
The Revolution has Started
Capitainer®SEP10 is developed for collection of blood where the cells are separated from the blood at the site of collection without centrifugation. The cell separated blood matrix is metered to an exact volume and dried for best shipping stability in ambient temperature.
Capitainer®SEP10 generates a plasma-like sample ideal for testing of substances that cannot be measured from a whole blood sample.
Accurate
Automatically generates 2×10µL cell separated blood
Reliable
Microfluidic control of correct volume
Trusted
Successful sampling indicator integrated in the device
Protected sample
Sample protected from contamination
User-friendly
Separated blood without centrifugation
Capitainer®SEP10
Sampling with Capitainer® SEP10
Generating separated blood is simple! Just apply blood to the device, and our state-of-the-art technology will automatically handle the rest. Say goodbye to the need for time consuming phlebotomy. Conveniently ship at ambient temperature.
Check the instructions to see how easy sampling can be.
Design
Designed for Ease – Built for Performance
A few drops of blood are added to the inlets of the card up until the stop line. The blood is transferred to the extraction chamber where blood cells are separated from the liquid through a membrane. After filling of the metering channel, a pinch off mechanism is initiated which separates an exact volume of plasma-like from surplus liquids. The separated blood is transferred into a sample disc.
For the Lab
There are some aspects to consider when you perform validation tests in the laboratory:
Pre-Analytical Card Handling
The first step is to transfer the dried sample from the card into a tube or plate for elution or extraction.
This step can be performed manually or automated. Check the option at our Lab Solutions page.
Sample disc transfer
1. Rip off the paper cover as illustrated to expose the sample discs.
2. Use a pair of tweezers with flat tips (preferably Capitainer sample disc tweezer) to remove the outlet discs in the order as demonstrated here. Insert the tweezer tip beneath the disc with an angle, and lift the disc in a scooping motion.
3. A correct removal means that both the paper disc and the glass fiber disc are removed. The center should be clean, no fragments of the glass fibre disc should be left (see pictures).
If removal is incomplete, use tweezers to remove the glass fiber disc.
Incomplete disc removal can affect sample volume accuracy.
Video instruction
Technical Specifications
Accuracy
Reproducibility:
Standard deviation less than 0.98 μl (CV < 2%).
Outliers:
Probability of overfilling or underfilling (deviation> 3 SD) < 1%.
Risk of no sample: < 1%.
Product performance
The product generates 2 x 10µl of plasma/serum-like dried sample from 2 x 70µl whole blood with a precision < 3% volume CV from whole blood in the range of 35-55% HCT.
Product storage and handling
Storage conditions before use: Temperature; 15°C to 28°C, relative humidity; 10% to 99%. Avoid direct sunlight and moisture.
Unopened devices can be stored under the above-mentioned conditions until the expiry date printed on the device packaging.
Regulatory Notice
Capitainer®SEP10 is a CE-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. Test providers are responsible for validating the assay results from Capitainer® products.
Responsible Manufacturer
CAPITAINER AB
Solna Torg 19
SE-171 45 Solna
Sweden
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