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Serum Iron and Iron-binding Capacity: A Round-Robin Interlaboratory Comparison Study

¹ Division of Nutrition and Physical Activity, National Center for Chronic Disease Prevention and Health Promotion

² Division of Laboratory Sciences, National Center for Environmental Health

³ Division of Diabetes Translation, National Center for Chronic Disease Prevention and Health Promotion, and
⁴ Scientific Resources Program, National Center for Infectious Diseases, CDC, Atlanta, GA 30341

^aaddress correspondence to this author at: 770 Buford Hwy NE, MS K-26, Atlanta, GA 30341; fax 770-488-6027, e-mail Hblanck@cdc.gov

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A panel convened by the CDC recommended that transferrin saturation be used as the initial test for hemochromatosis (1). Transferrin saturation can be calculated from the ratio of serum iron concentration to total iron-binding capacity (TIBC) expressed as a percentage [(serum iron/TIBC) x 100] or, instead, using the sum of serum iron and unsaturated iron-binding capacity (UIBC): TIBC_calc = serum iron + UIBC. We conducted a round-robin interlaboratory comparison study to assess the comparability of results for serum iron and iron-binding capacity assays.

To solicit participants, we sent invitations to iron experts (n = 10) and an announcement was placed on the Clinical Chemistry/General Topics listserv and in the American Association for Clinical Chemistry Nutrition Division newsletter; separate announcements were sent to at least 25 providers of US diagnostic services. A CDC Institutional Review Board approved the protocol (no. 2552). A contracted blood donor center collected 1 unit of blood from each anonymous human donor who gave informed consent. The donor center was also instructed to invite hemochromatosis patients to participate to ensure samples with increased iron status but free of iron supplement use. Serum was made by collecting the blood in bags with no anticoagulant. The blood was allowed to clot for several hours and centrifuged, and the serum was decanted. No manipulation (i.e., addition of analyte) of serum samples was done. Each serum sample was tested for serum iron and TIBC in the Nutrition Laboratory at CDC, using the Alpkem Flow IV colorimetric methods (2)(3). The methods are semiautomated applications of the NCCLS-recommended manual methods (4). On the basis of the transferrin saturation values, we combined four samples to create a pool representing marginal iron status (low pool), three to create a pool that was borderline increased and therefore close . . . [Full Text of this Article]