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EASY EXTRACT™

EASY EXTRACT™
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EASY EXTRACT™

Product catalog summary
Intended Use
The Calpro Easy Extract™ is designed for the sampling and extraction of Calprotectin from human stool samples, suitable for use by patients or clinical staff. It is validated for use with CalproLab™ Calprotectin ELISA and CalproGold Turbidimetric assay and is intended for single-use in vitro diagnostics.

Materials
The device includes a tube with extraction buffer, a blue adaptor cap, and a red cap with a sample rod.

Stability and Storage
  • Unopened Device: Stable until expiry when stored at 2-8°C, 20-25°C, or 37°C for 12 weeks, and 45°C for 2 weeks.
  • Device with Faecal Extract: Stability varies by storage condition: -20°C for 12 months, 2-8°C for 7 days, and 20-25°C for 5 days. Extracts can be freeze-thawed up to 3 times without significant impact.

Extraction Procedure
  1. Remove the required number of devices from the box.
  2. Release the stick by rotating the red cap counter-clockwise.
  3. Insert the stick into the stool sample, ensuring grooves are filled.
  4. Reinsert the stick into the tube, locking the red cap.
  5. Vortex the device for about three minutes to ensure complete suspension.
For analysis, further vortexing is recommended to ensure homogeneity.

Performance
  • Precision: Extraction precision was tested with CalproLab™ ELISA and CalproGold assays, showing consistent results across operators and days.
  • Sample Uptake: Mean weight of feces collected was 29.2 mg with a % CV of 2.7.
  • Comparison to Weighing Method: Results were equivalent to the original weighing method.

Limitations
Calprotectin may not be evenly distributed in stool samples. The device should not be used past its expiry date or if contaminated.

Safety and Precautions
Follow all instructions and safety guidelines strictly. Handle stool samples with care to avoid contamination.

Disposal Considerations
Dispose of biological hazardous waste according to local regulations.

Ordering Information
Product codes: CAL0510, CAL0510L, with devices labeled with lot and expiry dates.
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Catalog excerpts

EASY EXTRACT™-1

CalproEASY EXTRACT™ Quick and easy stool sample collection and extraction for Calprotectin measurement

 Open the catalog to page 1
EASY EXTRACT™-4

Calpro Easy Extract™ is intended for sampling and extraction of Calprotectin from human stool samples. Sampling can be performed by patient or by clinical/ laboratory staff at the hospital/lab. This device has been validated in combination with CalproLab™ Calprotectin ELISA and CalproGold Turbidimetric assay. The device is for in vitro diagnostic use. The device can only be used once. The extraction device consists of A. A tube filled with extraction buffer B. A blue adaptor (cap) screwed to the tube. C. a red cap with a sample rod (white stick with grooves in the end) The buffer in the extraction...

 Open the catalog to page 4
EASY EXTRACT™-5

Stability of fecal extracts to be analyzed with CalproLab or CalproGold is shown below at various storage conditions: The stability of calprotectin stated in the table is the longest achievable stability if the samples were stored at the stated temperature right after the extraction. A sample that for instance has been kept at room temperature for 4 days, will not be stable in at 2-8°C for 7 days after that. Extracted samples sent to the lab by mail should be placed at 2-8°C if they are to be analyzed within 24 hrs and -20°C if they are to be analyzed later than that. This is to make sure that...

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EASY EXTRACT™-6

necessary, further vortexing may be performed so that grooves are free of faeces and larger particles are broken down (Img 5 and 6). If the samples are to be analyzed the following day or later, they can be stored according to table in 3.2 after vortexing. It is then important to repeat vortexing prior to analysis to ensure the homogeneity of the preparation. Skipping the vortexing before the run can lead to measuring lower levels of calprotectin. Samples can safely be stored for analysis at later point. For information on extract stability, please refer to 3.2 in this booklet. The extract represents...

 Open the catalog to page 6
EASY EXTRACT™-7

Practical advice when using Easy Extract™ • It is not necessary to have morning stool sample for extraction, but the duration from last bowel movement until the one the sample is taken from will have a say in levels of Calprotectin. • Calprotectin in stool can be unevenly distributed, thus by stirring around the sample a more correct result will be obtained. • Samples that are very fluid will still contain Calprotectin if present, however these samples can be very difficult to collect using the sample rod. In these cases, it is recommended to apply 30 |il of sample using a pipette. • If patient...

 Open the catalog to page 7
EASY EXTRACT™-8

An aliquot from 30 samples with different texture (2 to 6 according to Bristol Stool Chart) were taken using the Easy Extract sampling rod and the blue adaptor. Mean weight of feces collected in the grooves of the sampling rod was 29.2 mg with a % CV of 2.7. Selected patient stool samples (n=52) were extracted using the EasyExtract™ devices according to the procedure described in Section 4. In parallel, the same stool samples were extracted using the original weighing method2). The samples varied both in concentration and texture. The extracts were measured with the CalproLab™ Calprotectin ELISA...

 Open the catalog to page 8
EASY EXTRACT™-9

Figure 10: Calprotectin levels (ng/mL) in stool extracts prepared with Calpro Easy ExtractM (CAL0510) and the original weighing method. All samples were measured with CalproLab ™ Calprotectin ELISA (CALP0170). When carefully following the procedure, approximately 30 mg faeces will be extracted. For very fluid samples, the sample vial can be filled using a pipette (take out 30 p.L fluid sample). Please note that Calprotectin is present in the fluid as well as the solid part of stools. Calprotectin in stool may not be evenly distributed throughout the sample. Even after homogenization of the sample,...

 Open the catalog to page 9
EASY EXTRACT™-10

Symbols Key / Symbolschlussel /Tabela de slmboios CALPRO is a registered trademark of CALPRO AS, Lysaker, Version 06(2023-04-24)

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EASY EXTRACT™-12

CALPRO is a registered trademark of CALPRO AS, Lysaker, Norway Version 06 (2021-04-24) Calpro AS - a Svar Life Science company Arnstein Arnebergsvei 30, N-1366 Lysaker, Norway +47 40 00 42 79 | [email protected] | www.calpro.no

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