Microsoft word - tdm_gelz_vs_gelp3n_vs_bd_otw15_marketing_rev01_folder.doc

Comparison of VACUETTE® Serum Gel tubes with Therapeutic Drug Monitoring (TDM) in Serum Background:
Greiner-Bio-One, Austria has sold plastic evacuated tubes (VACUETTE®) for venous blood collection VACUETTE® Gel Tubes incorporate an inert gel material into the blood collection tube. These gels have a controlled viscosity and a specific gravity intermediate to serum and clot. During centrifugation, the gel material forms an impermeable barrier The samples were analyzed for 15 TDM parameters on the following instruments according to Gel Z has been in development since 2001 and has manufacturer's instructions and protocols and using the same components as the last gel type (Gel P3), the difference being the production process, which Tested Drug
Analyzer
has been optimised. The gel might be slightly more yellow in colour however provides the better performance than the last gel type as well as providing the advantage of a more stable barrier, which is particularly beneficial during transport. Preanalytical handling remains the same and does not require any changes (i.e. centrifugation Study Objective:
The aim was to study the stability of a variety of commonly monitored drugs in serum after storage in VACUETTE® serum separator tubes on Gel Z or Gel P3N in comparison to a plain glass VACUTAINER® Study design:
Three tube types were evaluated in this study: Results – Evaluation:
There are two graphs shown for each drug tested, for one displaying low and the other displaying high drug quality control level (pink: VACUETTE® Gel Z, yellow: A serum pool was prepared by combining residual VACUETTE® Gel P3N, blue: Vacutainer® plain glass samples. This serum pool was split into two for each drug tested and each half was spiked with commercial quality control material (BioRad Muliqual Level III) to create a "low" and a "high" level to reflect Results / Comments:
the lower and the upper end of the therapeutic range. Percent recovery was calculated and was expected For each tube to be evaluated, two sets of duplicate to fall within +/-10% of the initial time control tube tubes were labelled 0, 4, 24, and 48 h. 3,0 ml of "low" values. Values falling below 90% or above 110% pool was aliquoted into one set of duplicate tubes recovery were considered clinically significant. and 3,0 ml "high" pool was aliquoted into the second Stability of the drug on the gel up to 48 hours was shown for all of the 15 drugs tested. These included Immediately after aliquoting, the samples were the analgesics Acetaminophen, Carbamazepine, and analyzed in duplicate to obtain the "0 hours" values. Salicylate; the antibiotics Gentamycin, Tobramycin, The tubes were then stored at 4°C and the serum and Vancomycin; the anti-epileptics Phenobarbital, was analyzed in duplicate at 4, 24, and 48 h. Phenytoin, and Valproic Acid; the anti-arrhythmic drug Procainamide and its metabolite n-Acetylprocainamide; the cardiac glycoside Digoxin; the alcohol ethanol; tricyclic antidepressants and the anti-spasmodic Theophylline. Conclusion:
From these findings we conclude, that tubes The stability of therapeutic drugs in serum stored in containing Gel Z performed comparably to tubes gel tubes has been widely investigated. The containing Gel P3N and plain glass tubes, and that absorption of drugs into the gel is dependent upon several factors including the chemical nature of the References:
gel and of the drug itself, time on the gel, temperature (1) Dasgupta A., Yared M.A., Wells A., Time- dependent absorption of therapeutic drugs by In this current study the stability of 15 drugs added to the gel of the Greiner Vacuette® blood collection a serum pool under laboratory conditions was examined. Tubes containing Gel Z showed constant (2) Mutschler Ernst, Arzneimittelwirkungen. drug level over 48 hours for most of the analytes Wissenschaftliche Verlagsgesellschaft mbH tested and no clinical significance was observed. Annex / Results – Raw Data:
Recovery after x hours [%]
Concentration
Tube Type
Recovery after x hours [%]
Concentration
Tube Type
Acetaminophen low
Acetaminophen high
Carbamazepine low
Carbamazepine high
Digoxin low
Digoxin high
Ethanol low
Ethanol high
Gentamycin low
Gentamycin high
n-Acetylprocainamide low
n-Acetylprocainamide high
Phenobarbital low
Phenobarbital high
Phenytoin low
Phenytoin high
Procainamide low
Procainamide high
Salicylate low
Salicylate high
Theophylline low
Theophylline high
Tobramycin low
Tobramycin high
Tricyclic Antidepressants low
Tricyclic Antidepressants high
Valproic Acid low
Valproic Acid high
Vancomycin low
Vancomycin high

Source: http://www.greinerbioone.nl/documents/TDM_GelZ_vs_GelP3N_vs_BD_OTW15_Marketing_Rev01_folder.pdf