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Membrane-based plasma-like sample separation without centrifugation
The Capitainer®SEP10 is developed for the collection of blood where cells are separated from the sample at the point of collection, without centrifugation. The cell-separated blood matrix is metered to an exact volume and dried for shipping stability at ambient temperature.
The card generates a plasma-like sample intended for the testing of substances that cannot be measured reliably from a whole blood sample.
Blood is applied to the card's inlets up to the marked stop line. The sample moves into an extraction chamber, where a membrane separates blood cells from the liquid fraction. Once the metering channel is filled, an integrated pinch-off mechanism isolates an exact volume of the plasma-like fraction from the surplus liquid. The separated sample is then transferred onto a sample disc for drying.
| Technical Data | |
|---|---|
| Sample type | Whole blood (input); cell-separated, plasma-like sample (output) |
| Input volume | 2 × 58 µl whole blood |
| Sample volume generated | 2 × 10 µl dried |
| Separation method | Membrane-based cell separation, no centrifugation |
| Sampling indicator | Integrated successful-sampling indicator |
| Performance | |
| Precision | < 3% volume CV, from whole blood in the 30–53% HCT range |
| Risk of no sample | < 5% (evaluated with EDTA whole blood) |
| Storage and Handling | |
| Storage temperature (unopened) | 15°C to 28°C |
| Storage relative humidity (unopened) | 10% to 99% |
| Storage precautions | Avoid direct sunlight and moisture |
| Shelf life | Unopened devices may be stored under the above conditions until the expiry date printed on the device packaging |
| Validated sample type | Fresh blood only; not validated for lyophilised blood products |
| Sample disc drying | Must be fully dry before storage, use, or analysis; overnight drying recommended |
| Compliance | |
| EU classification | CE-IVDR, Regulation (EU) 2017/746 |
| US classification | FDA-approved, Device Class 1 |
| Other regions | Research Use Only (RUO) where equivalent registration does not apply |
| Manufacturer | |
| Manufacturer | Capitainer AB |
| Address | Solna Torg 19, SE-171 45 Solna, Sweden |
Q: What does the Capitainer®SEP10 collect and generate?
A: It collects whole blood and generates 2 × 10 µl of cell-separated, plasma-like dried sample from 2 × 58 µl of whole blood, without centrifugation.
Q: How is a sample collected?
A: A few drops of blood are applied to the device's inlets up to the stop line. The card separates blood cells from the liquid fraction through an integrated membrane and meters an exact sample volume.
Q: Does the Capitainer®SEP10 require centrifugation?
A: No. Cell separation takes place within the card at the point of collection.
Q: Can the device be used with lyophilised blood products?
A: No. The Capitainer®SEP10 is validated for use with fresh blood only.
Q: How should the sample disc be handled before storage or analysis?
A: The disc must be completely dry before storage, use, or analysis. A wet disc may not detach correctly from the card, so overnight drying is recommended.
| Brand | Capitainer |
|---|