Please Wait...

Impact of freezer failure on bone marker stability during serum sample storage

Yannick Lhoste, Philippe Vergnaud, Emeric Chassaing, Kafui Agbokou, Tanja Schubert, Bioclinica Lab, Lyon, France

Bone turnover markers are frequently used as pharmacodynamics biomarkers in clinical studies. Serum samples used to assess bone markers are collected at clinical sites, frozen, and subsequently sent to central laboratories in polystyrene boxes on dry ice. Upon arrival, serum samples are stored in -70°C freezers before being measured in batches.

We investigated the stability of the bone markers CTX-I (carboxy-terminal telopeptide of type 1 collagen), PINP (aminoterminal propeptide of type 1 collagen), Osteocalcin,  measured on Modular E170, Roche Diagnostics and BSAP (bone-specific alkaline phosphatase), measured on Access II, Beckman Coulter, after a simulation of freezer temperature increase caused by power or equipment failure.

Several aliquots of 6 different serum pools were stored in a full -70°C freezer for 20 days. Then, electricity failure was simulated and the resulting temperature increase was monitored over the following 60 hours. One aliquot of each serum pool was taken out of the freezer after 8, 24, 32 and 60 hours respectively and refrozen at -70°C until analysis.

 

RESULTS

Mean values

ng/ml

Baseline

(-75°C)

8 hrs.

(-53°C)

24 hrs.

(-45°C)

32 Hrs.

(-10°C)

60 hrs.

(+4°C for 1 hr.)

CTX-I

(p results)

0.462

0.462 (1.0)

0.459 (0.92)

0.461 (0.68)

0.459 (0.20)

P1NP

56.05

56.08 (0.83)

56.01 (1.0)

56.76 (0.40)

55.49 (0.83)

OC

27.59

27.85 (0.92)

27.63 (0.68)

28.14 (0.53)

28.15 (0.17)

BSAP

13.70

13.93 (0.40)

13.51 (0.83)

13.63 (1.0)

13.64 (1.0)

 

No statistical difference (Wilcoxon test) was observed for the 4 bones markers tested between baseline samples and the follow-up samples at 8, 24, 32 and 60 hours.

CONCLUSIONS

Freezer temperature failure over 60 hours does not affect the validity of the data generated for the 4 bone turnover markers tested.

LEARN MORE OR SPEAK WITH OUR EXPERTS

CONTACT US
Leader in Clinical Trial
Management Solutions

Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

Dr Joby John chairing a panel discussion tomorrow 8am at #DIA2019 on ways to improve connectedness of clinical data… https://t.co/BPzi1geKsv
Bioclinica (14 hours ago)
Meet the Bioclinica team at DIA Booth 1831. #DIA2019 https://t.co/pvvdiqJz32 https://t.co/tx4PLDIrMm
Bioclinica (16 hours ago)
We’re at #DIA2019. Visit us at booth #1831 to learn more about our rapidly growing services and meet face to face… https://t.co/rK7V1Aclov
Bioclinica (19 hours ago)
Learn about When EDC is not enough: Automating multi-country data collection and complete workflows at #DIA2019! Ja… https://t.co/zJfytNpz82
Bioclinica (1 week ago)
In San Diego for #DIA2019? Visit us at booth #1831 and meet face to face with our team to learn more about our rapi… https://t.co/T4U4oNXlxo
Bioclinica (2 weeks ago)
We're celebrating International #NASH Day to help raise awareness about non-alcoholic steatohepatitis & fatty liver… https://t.co/16PfGbzeaS
Bioclinica (2 weeks ago)

Latest Blogs:

Medical Imaging of Non-Alcoholic Fatty Liver Diseases in Clinical Trials
EDC Provider Selection
Site Payments Solutions
Nonalcoholic steatohepatitis (NASH) development programs
Dr. Joby John
Transformational Trends in Investigator Site Payments
Clinical Supply Chain Success: Leveraging Technology
Blood pressure monitor
Prescription box