Instructions for use

Simsen Personal Baseline Collection Kit.

Tissue + Normal + ctDNA
The first-visit kit. Use it to send tumour tissue for the personalised panel, a matched normal control, and the first ctDNA blood draw, all in one box. Set the patient up once, then monitor with the Follow-up kit.

Download PDF (Tissue IFU) Download PDF (Blood IFU)

Kit contents

Check that everything below is in your box before you begin. If anything is missing, contact us before you start.

screw-cap-vials

Screw-cap vials x2

for FFPE sections

tissue-specimen-box

Tissue specimen box x1

holds the vials or block

streck-tubes

Streck tubes x2

10 ml, tan cap (ctDNA)

edta-tube

EDTA tube x1

6 ml, purple cap (normal)
sample-id-stickers

Sample ID stickers x3

barcode and ID
biohazard-bag

Biohazard bag x1

resealable
absorbent-pouch

Absorbent pouch x1

leak absorption
gel-pack

Gel pack x1

cushioning
metallic-envelope

Metallic envelope x1

sealed containment
requisition-form

Requisition form x1

complete and enclose
original-box

Baseline Kit box x1

use for return

Storage

Keep the kit and any samples within range. Temperature is the most common cause of an unusable sample.

Storage conditions
18 to 30 °C
Unopened kitStore between 18 and 30 °C. Do not exceed this range.
6 to 37 °C
Drawn blood samplesKeep between 6 and 37 °C. Do not freeze.

FFPE tissue is stable at ambient temperature. The whole kit, blood and tissue together, ships at room temperature using the enclosed return label.

The five steps

Work through them in order.

1

Prepare the tumour tissue sample

Use formalin-fixed paraffin-embedded (FFPE) tissue. Fix in 10 percent neutral-buffered formalin. Send the most recent FFPE section that corresponds to the current clinical presentation.
  1. Place 5 fresh sections from the FFPE block into each screw-cap vial: 10 sections in total, 10 to 20 µm each.
  2. Tumour content should be greater than 30 percent, as assessed by you.
  3. Avoid heavily necrotic, poorly fixed, or overly fixed tissue.
Return both vials to the tissue specimen box and seal it.
2

Collect the blood samples

  1. Use two 10 mL Streck tubes (tan cap) for every patient.
  2. Draw one 6 mL EDTA tube (purple cap) for the matched normal control. The EDTA control is collected once, here in the Baseline kit.
  3. Fill each tube to capacity. If the volume is insufficient, draw an additional tube.
  4. Allow each tube to fill for 60 to 90 seconds. Use a 21-gauge straight needle for venepunture.
3

Rotate Streck samples gently

Immediately after drawing, gently rotate each Streck tube at least ten times to mix the blood with the reagent. 

Do not shake the samples.

Do not seal the tubes with parafilm.

4

Prepare samples for shipment

1
Label each tube, the sealed tissue specimen box, with the patient ID and collection date or timepoint.
2
Place the blood tubes inside the absorbent pouch.
3
Insert the absorbent pouch and the tissue specimen box into the biohazard bag.
4
Place the biohazard bag inside the gel pack for cushioning.
5
Put the gel pack and biohazard bag into the metallic envelope.
6
Complete the requisition form and attach a sample ID sticker.
5

Ship the prepared samples

1
Place the sealed metallic envelope and the completed requisition form into the Baseline Collection Kit box.
2
Attach the return label and seal the package. If preferred, place the kit box inside a secondary envelope and apply the label to the outer packaging.

Coming back for monitoring?

Once a patient is set up with the Baseline kit, every later ctDNA timepoint uses the Follow-up ctDNA Collection Kit, two Streck tubes, no tissue or control needed.

Follow-up Kit guide →
QUestions before you start?
 

Talk to the laboratory?

A real human, in CET/CEST time zone, who handles samples like yours every day.