Table 5.

Qualitatively detectable results per manufacturer definition,^a by control matrix

Control matrix and assay	Results for samples with nominal concn of:				P valueb
	25 copies/ml		50 copies/ml
	No. of samples	% qualitatively detectable	No. of samples	% qualitatively detectable
Citrate
ARAUTO	40	90	80	100	1.00
ARMAN	12	92	24	96	0.71
RTv1	36	92	72	96	0.70
RTv2	4	100	8	100	1.00
STDCAM	20	25	40	28	<0.001
STDCOB	8	0	16	13	<0.001
STDMONc
STD	28	18	56	23	<0.001
USCAM	12	83	24	96	0.71
USCOB	4	100	8	100	1.00
USMON	16	81	32	97	0.81
US	32	84	64	97	0.84
EDTA
ARAUTO	12	67	24	71	<0.001
ARMAN	32	88	64	100	1.00
RTv1	12	67	24	83	0.03
RTv2	24	88	48	98	0.91
STDCAMc
STDCOB	16	31	32	31	<0.001
STDMON	20	0	32	20	<0.001
STD	36	14	72	25	<0.001
USCAM	8	38	16	63	<0.001
USCOB	4	100	8	100	1.00
USMON	4	100	8	100	1.00
US	16	69	32	81	<0.01

^aThe validation controls used for this testing were designed to evaluate assays with ultralow detection limits (50 copies/ml or less). Standard Roche assays (STDMON) have lower detection limits of 400 copies/ml. A blank indicates no data were received for this assay.

^bA P value is provided for each assay to indicate if the detection rate of the sample with a nominal value near the lower detection limit of the assay (e.g., 50 copies/ml) was significantly different (too many false negatives) than what would be expected by chance alone for a 95% detection rate.

^cData were not received for STDMON in citrate or for STDCAM in EDTA.