Definition of the upper reference limit for thyroglobulin antibodies according to the National Academy of Clinical Biochemistry guidelines: comparison of eleven different automated methods

D’Aurizio, F.; Metus, P.; Ferrari, A.; Caruso, B.; Castello, R.; Villalta, D.; Steffan, A.; Gaspardo, K.; Pesente, F.; Bizzaro, N.; Tonutti, E.; Valverde, S.; Cosma, C.; Plebani, M.; Tozzoli, R.

doi:10.1007/s13317-017-0096-3

Table 1 Analytical performance characteristics of the current TgAb automated immunoassays

From: Definition of the upper reference limit for thyroglobulin antibodies according to the National Academy of Clinical Biochemistry guidelines: comparison of eleven different automated methods

Method	Immunoassay principle	Tracer/enzyme	Assay type	Imprecision (%):intra-; inter-; total	LoD^d (IU/mL)	LoQ^d (IU/mL)	Assay range (IU/mL)
AIA	FEIA	4MUP/ Alkaline phosphatase	NC	4.3–5.1; nd; 5.5–6.0	0.12	nd	0.12–2000
ARC	CLIA	Acridinium esters	NC	1.7–6.6^b; nd; 2.7–8.2^b	0.07	0.31	0.07–1000
CEN^a	CLIA	Acridinium esters	C	2.9–5.5; 1.8–2.0; 3.5–5.8	10	30^e	10–500
CL2	CLEIA	Difurat^®	NC	5.1–5.5; 5.8–6.6; nd	0.005	nd	0.005–2500
COB	ECLIA	Ruthenium derivatives	C	1.3–5.6^c; 2.1–8.7^c; nd	10	nd	10–4000
IMM	CLIA	Adamantyl dioxetane phosphate/Alkaline phosphatase	NC	3.2–4.9; 4.6–5.8; nd	2.2	nd	20–3000
KRY^a	TRACE	Europium cryptate/ XL 665	C	1.5–3.5; 6.8–20.0; nd	10	33	10–850
LIA	CLIA	Isoluminol derivatives	NC	2.3–3.2; 4.4–8.9; nd	5	10	5–5000
LUM	CLEIA	AMPPD	NC	1.8–4.6; nd; 2.5–5.3^c	5.152	5.152	5.152–3000
MAG	CLIA	ABEI	NC	2.8–9.1; 5.2–9.8; nd	10	nd	10–2800
PHA	FIA	4-methyl-umbellipheryl-β-d-galactoside/β-galactosidase	NC	3.3–5.6; 2.6–6.5; nd	12	nd	12–4794

4MUP 4-methyl-umbelliferyl phosphate, ABEI N-(aminobutil)-N-(ethyl)-isoluminol, AIA AIA-2000, Tosoh Bioscience, AMPPD alkaline phosphatase-spiroadamantyl-methoxy-phosphoryloxy-phenyl-dioxetane, ARC Architect, Abbott Diagnostics, C competitive immunoassay, CEN Advia Centaur XP, Siemens Healthineers, CL2 AIA CL-2400, Tosoh Bioscience, CLIA chemiluminescence immunoassay, CLEIA chemiluminescence enzyme immunoassay, COB Cobas 6000, Roche Diagnostics, ECLIA electrochemiluminescence immunoassay, FEIA fluorescence enzyme immunoassay, FIA fluoroimmunoassay, IMM Immulite 2000 XPi, Siemens Healthineers, KRY Kryptor, Thermo Fisher Scientific BRAHMS, LIA Liaison XL, Diasorin, LUM Lumipulse G, Fujirebio, MAG Maglumi 2000 Plus, Snibe, NC non-competitive immunoassay, nd not declared, PHA Phadia 250, Phadia AB, Thermo Fisher Scientific, TRACE time resolved amplified cryptate emission
^aAll methods are standardized with the reference preparation MRC 65/93 and use International Units (IU/mL) except for Centaur and Kryptor which refer to a secondary standard and use Arbitrary Units (AU/mL); to obtain IU multiply for the conversion factor 2.8 (CEN) and 7.14 (KRY)
^bPrecision defined by the NCCLS Protocol EP5-A [26]
^cPrecision defined by the modified NCCLS Protocol EP5-A2 [27]
^dLoD and LoQ defined by the CLSI protocol EP17-A [28]
^eFunctional sensitivity defined as TgAb concentration with total CV ≤20%, determined for a period of two days using one lot of reagents and testing, by four instruments, multiple samples from normal patients

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ISSN: 2038-3274

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