TABLE 1.

Standard curve parameters

Parameter	Antigen
	PT	PRN	FHA	FIM 2/3	DT	TT
International WHO standard
Coefficient of determination (R2)	0.99	0.99	0.99	0.99	0.99	0.99
Calculated line slope	0.97	0.96	0.94	0.89	1.01	0.99
GMC (IU/mL)	335	65	130	560	2.0	120
Acceptance criteria (±20% GMC)	268–402	52–78	104–156	448–672	1.6–2.4	96–144
Detection limits (IU/mL)
Calculated low	0.00241	0.00047	0.00104	0.00429	0.00003	0.00001
Calculated high	1.680	0.325	0.650	2.8	0.020	0.004
In-house standard
Coefficient of determination (R2)	0.99	0.99	0.99	0.99	0.99	0.99
Calculated line slope	0.99	0.98	0.98	0.97	0.98	0.98
GMC (IU/mL)	134.7	96.3	263.7	807.1	1.1	5.4
Acceptance criteria (±20% GMC)	107.8–161.6	77.1–115.6	211.0–316.5	645.6–1,452.7	0.9–1.3	4.3–6.5
Detection limits (IU/mL)
Calculated low	0.00100	0.00086	0.00200	0.006	0.00095	0.00004
Calculated high	0.67	0.480	1.320	4.04	0.006	0.030
In-house standard breast milk IgG
Coefficient of determination (R2)	1.00	1.00	1.00	-	1.00	0.98
Calculated line slope	0.97	0.97	0.98	-	1.00	1.09
GMC (IU/mL)	5.49	4.54	12.3	-	0.04	0.25
Acceptance criteria (±20% GMC)	4.39–6.59	3.63–5.45	9.84–14.76	-	0.03–0.05	0.20–0.30
Detection limits (IU/mL)
Calculated low	0.00081	0.00065	0.00172	-	0.00001	0.00004
Calculated high	0.549	0.454	1.230	-	0.004	0.025
In-house standard breast milk IgA
Coefficient of determination (R2)	0.99	0.99	0.99	-	0.99	0.99
Calculated line slope	1.09	0.97	1.06	-	1.09	0.99
GMC (IU/mL)	44.20	24.31	22.00	-	3.02	16.12
Acceptance criteria (±20% GMC)	35.36–53.04	19.45–29.17	17.60–26.40	-	2.42–3.62	12.90–19.34
Detection limits (IU/mL)
Calculated low	0.00477	0.00180	0.00207	-	0.00033	0.00096
Calculated high	1.473	0.810	0.733	-	0.101	0.537