Do Australian immunoglobulin products meet international measles antibody titer standards?

Figures & data

Figure 1. Measles antibody concentrations in Australian intramuscular immunoglobulin products by ELISA and PRNT and expressed as times CBER units.

Figure 2. Measles antibody concentrations in Australian intravenous immunoglobulin products by ELISA, PRNT and expressed as times CBER units.

Table 1. ELISA compared to PRNT measles-specific antibody results for Australian immunoglobulin products.

		Measles titer (IU/mg) GMT±GMSD
Product	Number of samples	ELISA	PRNT	Wilcoxon signed rank test p value	Ratio ELISA:PRNT
Australian IM immunoglobulin (16% w/v) (CSL Behring (Australia) Pty Ltd)	10	0.97 ± 1.38	0.39 ± 1.15	0.005	2.49:1
Australian IV immunoglobulin (6% w/v) (CSL Behring (Australia) Pty Ltd)	28	0.62 ± 1.62	0.24 ± 1.34	<0.001	2.58:1

Table 2. ELISA compared to PRNT measles-specific antibody results for New Zealand and United States of America immunoglobulin products.

		Measles titer (IU/mg)
		Individual sample values		GMT±GMSD
Product	Number of samples	ELISA	PRNT	ELISA	PRNT	Ratio ELISA:PRNT
New Zealand IM immunoglobulin (16% w/v) (CSL Behring (Australia) Pty Ltd)	2	1.28 0.73	0.29 0.24	0.96 ±1.50	0.27 ±1.14	3.56:1
Hizentra (20% w/v) for subcutaneous administration (CSL Behring AG) (US plasma derived)	3	0.34 0.30 0.40	0.20 0.17 0.37	0.34 ±1.16	0.23 ±1.51	1.48:1
Privigen (10% w/v) for IV administration (CSL Behring AG) (US plasma derived)	2	0.24 0.58	0.19 0.29	0.37 ±1.87	0.23 ±1.35	1.60:1