Custom Blood Collection Tubes
Custom Blood Collection Tubes for Clinical Research Applications
Many organizations have the need for sample collection tubes with custom formulations, sizes, vacuum draws and even vials specific to their clinical studies/trials for drug development. However, finding commercial sources and/or having them manufactured on a custom basis is often associated with high volume and cost requirements. Haematologic Technologies can provide custom formulated tubes in all shapes, sizes and amounts to meet your specifications in batch sizes as small as one. With an almost unlimited reagent selection, custom draw volumes, and customer-designated batch size you can get your tubes the way you want, and in the exact quantity you need. Uses include:
- pK (pharmacokinetic) studies
- Drug efficacy studies
- Development of a new collection tube for clinical use (medical device)
- Custom collection tubes for IVD (in-vitro diagnostic) kits and applications
Haematologic Technologies also offers OEM contract manufacturing of custom tubes for those who need a continuous supply for their process or product. Tubes will be manufactured to your specifications, on your time schedule, and with all the appropriate quality documentation.
Tubes are made to order: please allow 2-4 weeks turn around on tube orders.
To initiate a quote please fill out this form, and email to us at email@example.com.
Please see our tube FAQ at the bottom of this page.
Protease Inhibitor Blood Collection Tubes for Research Applications
Many non-routine tests and applications which require the collection of blood or other body fluids, also require the use of special anti-coagulant or proteinase inhibitor cocktails to preserve the integrity of the sample. Good examples of such tests include the measurements of Fibrinopeptide-A (FPA), Prothrombin Fragment 1•2 (F1•2), Fibrinogen Degradation Products (FDP) and the Thrombin/Antithrombin III complex (TAT), all of which are highly influenced by persistent protease activity in blood or plasma samples (1-8). The SCAT series of collection tubes (Sample Collection/Anticoagulant Tubes) were developed specifically to minimize in vitro artifact by rapidly quenching unwanted protease activity. SCAT tubes are carefully formulated to yield a reproducible concentration of inhibitors with rapid dissolution properties. The tubes are evacuated and stoppered under controlled conditions so that the tubes will automatically fill to the proper volume. Protease inhibitor tube formulations:
SCAT-1 (3, 5 and 10 mL) yielding the following concentrations in whole blood: 25 uM PPACK (Phe-Pro-Arg-chloromethylketone), 200 KIU/mL Aprotinin, 4.5mM EDTA, 0.1% Mannitol (w/v). Minimum order of 100.
SCAT-2 (3, 5 and 10 mL) yielding the following concentrations in whole blood:25 uM PPACK (Phe-Pro-Arg-chloromethylketone), 11 mM Sodium Citrate, 0.1 % Mannitol (w/v). Minimum order of 100. Please see note on hemolysis below*
SCAT-875B (3, 5 and 10 mL) yielding the following concentrations in whole blood:75 uM PPACK (Phe-Pro-Arg-chloromethylketone), 0.1% D-Mannitol (w/v). Minimum order of 100.
Tubes are made to order: please allow 2-4 weeks turn around on tube orders.
Although the SCAT tubes may resemble a standard phlebotomy blood collection tube, it should be noted that these tubes are NOT STERILE, and therefore should not be used as a standard blood collection tube. Instead, it is recommended that the technique used to collect the sample (whether it be blood or another fluid sample), be direct collection into the SCAT tube through a catheter of at least five inches, and equipped with a multi-sample luer adapter (MSLA) to eliminate the possibility of a back-flush from the non-sterile tube to the patient.
*Blood samples drawn into SCAT-2 tubes may hemolyze. Published literature indicates that low-to-moderate levels of hemolysis has no significant impact on the results of standard clotting tests such as the aPTT or PT, whether conducted on photo-optical or mechanical coagulometers. However, to ensure efficacy in your application, we recommend you conduct direct comparisons of normal and hemolyzed blood using the procedure and instrumentation employed in your laboratory.
- What tube types are available?
You may choose from different sizes of vacuum-draw tubes, screw-cap, cryo-vials or essentially any other vessel you need. The vial is up to you.
- What type of plastic is used to produce HTI's vacuum blood collection tubes? HTI's vacuum tubes are made from polyethylene terephthalate (PET). This special formulation is extremely strong, dimensionally stable, and resistant to chemicals and breakage. PET is the standard in the industry.
- Are your tubes for clinical use? No. All tubes are produced as a research use only product. While they can be used in your clinical research studies they cannot be used for patient diagnosis and treatment. HTI collection tubes are NOT FDA approved.
- Can you manufacture tubes with a serum separator gel?
Unfortunately, at this time we do not offer that option.
- Can you spray-coat the interior of the tube?
No. At this time we only offer liquid or lyophilized contents.
- How are the tubes packaged?
Most tubes are packaged 100 tubes/box or bag.
- Are your tubes endotoxin free?
No, we do not claim that any of the tubes are endotoxin free.
- What are the expiration dates of your custom tubes? Since these are custom made to your specifications we are not able to give them an expiration date. You may, however, commission a stability study to determine this date OR ask us to put on a date that you have decided on internally.
- How should expired/unused tubes be disposed of?
Local trash collectors should be consulted to see what the proper method of disposal is for unused, expired blood collection products.
- Can you sterilize your tubes? No, we cannot. All of our tubes are non-sterile, for research use only. You have the option of contacting a third party sterilization company of your choice for this service. However, a validation process may be necessary, which requires multiple lots of tubes and may be a considerable expense. If you choose to pursue sterilization we can ship directly to the sterilization company you choose.
- How long will it take for you to manufacture my tubes?
We operate on a first-come, first-served systems. For most orders there is a 2-4 week turn around time, which can be shorter or longer depending on the queue and tube complexity.
- At what temperature should the tubes be stored prior to use?
We generally recommend storing our tubes at 4oC.
- What is the proper way to perform phlebotomy with your vacuum tubes?
Since our tubes are non-sterile we require that all phlebotomy be performed with a winged collection set to prevent back-flush.
- What is the proper order of draw for the blood collection tubes? When using a winged collection set for venipuncture and a coagulation tube is the first tube drawn (citrate for example), a discard tube should be drawn first. While you don't need to completely fill the discard tube you do want to completely eliminate the dead space in the tubing. This will ensure proper blood-to-additive ratio when drawing into the "live" use tube. With regard to drawing into multiple tube types the recommendation is to draw for the least sensitive analytes first, and the most sensitive last. For example if you had a serum tube, citrate tube, and protease inhibitor tube the first tube would be the serum tube (because you are already allowing for the natural generation of pro-coagulant enzymes). Once the serum tube has been drawn, and has effectively flushed the needle/catheter, you would draw the citrate and then the tube containing protease inhibitors last.
- How do I process the SCAT-1, 2 or 875B tubes? Centrifuge tubes at 1,500g for 15 to 20 minutes for a total of 22,500 to 30,000 g-minutes. Immediately after tubes are centrifuged, carefully place them upright at room temperature in preparation for pooling and aliquoting.
- What are the proper number of inversions for the tubes? This will vary depending on the component, and should be determined by your lab.
- How do I obtain package inserts for tubes that I have purchased previously?
Please email us at firstname.lastname@example.org or call +1 (802) 878-1777.
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