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G. Lippi et al. / Clinical Biochemistry 44 (2011) 1028–1029<br />

1029<br />

Fig. 1. Fluctuation <strong>of</strong> the inner temperature <strong>of</strong> a <strong>transport</strong>ation <strong>box</strong> during the 8-h study period.<br />

closure <strong>of</strong> the <strong>box</strong>, so that <strong>transport</strong>ation from the private facility to the<br />

core laboratory by courier as per manufacturer requirements started at<br />

this time point. After 7 h and 30 min <strong>of</strong> <strong>transport</strong>ation the <strong>box</strong> arrived<br />

at the destination, in the core laboratory. Temperature data were<br />

further analyzed with LogTag Analyser®. The limit <strong>of</strong> suitable<br />

temperature fluctuation was established between 2 °C and 8 °C (i.e.,<br />

35.6 °F—46.4°F), in agreement with the current recommendations <strong>of</strong> the<br />

Clinical and Laboratory Standard Institute (CLSI) [8]. The environmental<br />

temperature during <strong>transport</strong>ation was comprised between 36 °C and<br />

38 °C, whereas that <strong>of</strong> the private facility and the core laboratory was<br />

~20 °C.<br />

Results<br />

The fluctuation <strong>of</strong> the temperature within the <strong>transport</strong> <strong>box</strong> during<br />

the 8-h study period is shown in Fig. 1. Thirty minutes after the closure<br />

<strong>of</strong> the <strong>box</strong> at the private facility the temperature rapidly fell from room<br />

temperature (i.e., ~20 °C) to 6 °C, in agreement with manufacturer's<br />

claim. After beginning <strong>of</strong> <strong>transport</strong>ation, a nearly linear increase <strong>of</strong><br />

temperature was then observed, exceeding the upper suitable limit (i.e.,<br />

8 °C) after 120 min (i.e., 90 min from the beginning <strong>of</strong> <strong>transport</strong>ation).<br />

Twenty min after arrival at the core laboratory, the internal temperature<br />

<strong>of</strong> the <strong>transport</strong> <strong>box</strong> dropped down at 7 °C. As such, temperature<br />

stability could be considered unsatisfactory during approximately 64%<br />

<strong>of</strong> the <strong>transport</strong>ation time, i.e., from 125 to 450 min.<br />

Discussion<br />

The increasing centralization <strong>of</strong> laboratory facilities has raised<br />

important economical, organizational and preanalytical issues such as<br />

the escalation <strong>of</strong> costs, the <strong>long</strong>er <strong>transport</strong>ation times and the<br />

potential increase <strong>of</strong> preanalytical errors due to the <strong>of</strong>ten challenging<br />

conditions <strong>of</strong> <strong>transport</strong>ation and storage <strong>of</strong> the specimens [5,6].<br />

Establishment and maintenance <strong>of</strong> appropriate temperatures <strong>for</strong><br />

<strong>transport</strong>ation is essential <strong>for</strong> preserving the quality <strong>of</strong> whole <strong>blood</strong><br />

and even centrifuged specimens, thus preventing irreversible physicochemical<br />

alterations <strong>of</strong> <strong>blood</strong> components. According to the current<br />

recommendations <strong>of</strong> the CLSI, chilled <strong>blood</strong> specimens should be<br />

maintained at temperatures comprised between 2 °C and 8 °C until<br />

separation [8]. As such, the <strong>transport</strong>ation <strong>of</strong> <strong>sample</strong>s and <strong>blood</strong><br />

components is increasingly accomplished by safety <strong>transport</strong> <strong>box</strong>es,<br />

especially in countries with high or even extreme environmental<br />

temperatures and where <strong>shipment</strong> might occur <strong>over</strong> <strong>long</strong> distances.<br />

Nevertheless, no published data are available to the best <strong>of</strong> our<br />

knowledge on the per<strong>for</strong>mance <strong>of</strong> <strong>transport</strong>ation <strong>box</strong>es as regards<br />

temperature stability throughout <strong>long</strong> periods <strong>of</strong> <strong>transport</strong>ation, up to<br />

several hours. Although limited to the evaluation <strong>of</strong> a single<br />

commercial product the results <strong>of</strong> this investigation attest that the<br />

recommended temperature <strong>for</strong> <strong>transport</strong>ation (i.e., between 2 °C and<br />

8 °C) might only be maintained <strong>for</strong> a limited period <strong>of</strong> time within a<br />

<strong>transport</strong> <strong>box</strong> (e.g., up to 90 min), because the internal temperature<br />

might be dramatically influenced by the environmental conditions. As<br />

such, we hypothesized that some <strong>of</strong> these products might be<br />

unsuitable to fulfil the requirements <strong>of</strong> some peripheral facilities<br />

integrated within a network, especially those which ship the<br />

specimens to very distant core laboratories. Rather understandably,<br />

although all the experimental conditions were accurately standardized,<br />

replication <strong>of</strong> this study at different temperature (e.g., high or<br />

even extreme external temperatures) or humidity, as well as the use<br />

<strong>of</strong> different types <strong>of</strong> containers made on different materials, might<br />

provide different outcomes, so that additional studies should be<br />

planned to test this hypothesis.<br />

References<br />

[1] Plebani M, Lippi G. To err is human. To misdiagnose might be deadly. Clin Biochem<br />

2010;43:1–3.<br />

[2] Lippi G, Guidi GC, Mattiuzzi C, Plebani M. Preanalytical variability: the dark side <strong>of</strong><br />

the moon in laboratory testing. Clin Chem Lab Med 2006;44:358–65.<br />

[3] Lippi G. G<strong>over</strong>nance <strong>of</strong> preanalytical variability: travelling the right path to the<br />

bright side <strong>of</strong> the moon? Clin Chim Acta 2009;404:32–6.<br />

[4] Lima-Oliveira G, Picheth G, Sumita NM, Scartezini M. Quality control in the<br />

collection <strong>of</strong> diagnostic <strong>blood</strong> specimens: illuminating a dark phase <strong>of</strong> preanalytical<br />

errors. J Bras Patol Med Lab 2009;45:441–7.<br />

[5] Plebani M, Lippi G. Is laboratory medicine a dying pr<strong>of</strong>ession? Blessed are those<br />

who have not seen and yet have believed. Clin Biochem 2010;43:939–41.<br />

[6] Plebani M, Lippi G. Focused factories and boutique laboratories. The truth might lie<br />

in between. Clin Biochem 2010;43:1484–5.<br />

[7] Klose T, Borchert HH, Pruss A, Roth WK, Bohnen HR, Putzker M. Current concepts<br />

<strong>for</strong> uality assured <strong>long</strong>-distance <strong>transport</strong> <strong>of</strong> temperature-sensitive red <strong>blood</strong> cell<br />

concentrates. Vox Sang 2010;99:44–53.<br />

[8] Clinical and Laboratory Standard Institute. Procedures <strong>for</strong> the Handling and<br />

Processing <strong>of</strong> Blood Specimens; Approved Guideline—Fourth Edition. CLSI document<br />

H18-A3940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087 1898<br />

USA: Clinical and Laboratory Standards Institute1-56238-724-3; 2010.

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