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.

Reminder: Today's webinar on Clinical Endpoint Adjudication kicks off at 1 PM Eastern. > https://t.co/1IU9TVFCFA
bioclinica (2 days ago)
In a new go-to-guide on conducting #Alzheimer's clinical trials, @bioclinica experts Joyce Suhy, Marieke Cajal, Luc… https://t.co/SaBFm3L9CL
bioclinica (3 days ago)
Clinical Endpoint Adjudication Webinar. Join us in a live online event this Friday, (6/15) Details & reg. > https://t.co/uBjlgSMnDS
bioclinica (3 days ago)
Clinical Endpoint Adjudication webinar this Friday! Interested in establishing a universal clinical vocabulary to i… https://t.co/uPD992tSaY
bioclinica (4 days ago)
RT @Pints4PDOrlando: Amazingly grateful to @BioclinicaFLA @bioclinica for their super generous donation to @michaeljfoxorg @teamfox in our…
bioclinica (4 days ago)
RT @E_de_Azambuja: ESMO at ASCO2018: please visit booth 5078 if you want more information on ESMO activities and opportunities @myESMO #asc…
bioclinica (2 weeks ago)

Latest Blogs:

Latin America: Benefit from the Right Partner
Removing Risk from Clinical Trial Management System (CTMS) Implementations
Collaboration Between Clinical Operations and the Logistics and Supply Chain Teams is Key to Trial Success
The Value of Protocol Review
CTMS and RBM: Hot Topics at OCT Nordics in Copenhagen