Table 1 Immunoassays for diagnosis of... | American Society of Hematology

Table 1

Immunoassays for diagnosis of HIT: available classes of assays, antibody specificities, thresholds, test variations, and manufacturers

Classes of assays	Antibody specificity	Threshold	Test variation	Manufacturer (names of tests)
ELISA	Polyspecific	Low*	High heparin dose confirmation step	In-house assays
	IgG specific	Intermediate†		GTI Diagnostics, Waukesha, WI (GTI-PF4; HAT; PF4-Enhanced; GTI-IgG)
		High‡		Hyphen-BioMed, Neuville-Sur-Oise, France (Zymutest HIA IgGAM; Zymutest HIA IgG)
				Diagnostica Stago, Asnières-sur-Seine, France (Asserachrom HIPA)
				Gen-Probe (Gen-Probe PF4)§
				Technoclone GmbH, Vienna, Austria (Technozym)
PaGIA	Polyspecific	Low\|\|		Diamed, Cressier sur Morat, Switzerland (ID-H/PF4 PaGIA)
PaGIA	Polyspecific	Intermediate¶		Diamed, Cressier sur Morat, Switzerland (ID-H/PF4 PaGIA)
PIFA	Polyspecific	Positive/negative		Akers Biosciences Inc, Thorofare, NJ (HealthTEST)
Lateral flow immunoassay	IgG specific	Positive/negative		Diagnostica Stago (STic EXPERT HIT); Milenia Biotec, Giessen, Germany (Milenia QuickLine HIT)
CLIA	Polyspecific	Low#		Instrumentation Laboratory, Bedford, MA (HemosIL AcuStar HIT-Ab; HemosIL AcuStar HIT-IgG)
	IgG specific	Intermediate**
		High††
Latex agglutination assay	Polyspecific	Low‡‡		Instrumentation Laboratory (HemosIL HIT-Ab)

Classes of assays	Antibody specificity	Threshold	Test variation	Manufacturer (names of tests)
ELISA	Polyspecific	Low*	High heparin dose confirmation step	In-house assays
	IgG specific	Intermediate†		GTI Diagnostics, Waukesha, WI (GTI-PF4; HAT; PF4-Enhanced; GTI-IgG)
		High‡		Hyphen-BioMed, Neuville-Sur-Oise, France (Zymutest HIA IgGAM; Zymutest HIA IgG)
				Diagnostica Stago, Asnières-sur-Seine, France (Asserachrom HIPA)
				Gen-Probe (Gen-Probe PF4)§
				Technoclone GmbH, Vienna, Austria (Technozym)
PaGIA	Polyspecific	Low\|\|		Diamed, Cressier sur Morat, Switzerland (ID-H/PF4 PaGIA)
PaGIA	Polyspecific	Intermediate¶		Diamed, Cressier sur Morat, Switzerland (ID-H/PF4 PaGIA)
PIFA	Polyspecific	Positive/negative		Akers Biosciences Inc, Thorofare, NJ (HealthTEST)
Lateral flow immunoassay	IgG specific	Positive/negative		Diagnostica Stago (STic EXPERT HIT); Milenia Biotec, Giessen, Germany (Milenia QuickLine HIT)
CLIA	Polyspecific	Low#		Instrumentation Laboratory, Bedford, MA (HemosIL AcuStar HIT-Ab; HemosIL AcuStar HIT-IgG)
	IgG specific	Intermediate**
		High††
Latex agglutination assay	Polyspecific	Low‡‡		Instrumentation Laboratory (HemosIL HIT-Ab)

GTI, Genetic Testing Institute.

≤OD 0.7.

Between OD 0.8 and 1.4.

>OD 1.4.

Technically identical with GTI assay.

Positive/negative.

Titer 2 to 3.

1.0 U/mL.

1.0-2.8 U/mL.

>2.8 U/mL.

>3.85 U/mL.