TABLE 7.

BioFire PN panel discrepancy investigation for detection of bacteria

Analyte	Specimena	No. of results
		False positive vs. qRefCx (investigative method)					False negative vs. qRefCx (investigative method)				False negative vs. SOC culture (SOC quantityb )
		Total	BQc	Molecd	SOC	rTPe	Tot	Molecd	SOC	cFNf	Total	Few	Mod	Many	UQ
A. calcoaceticus-A. baumannii complex	BAL	7	1	6		7	0				0
	SPU	18		17	1	18	1			0g	3	0	2	1	0
E. cloacae complex	BAL	12	6	5		11	1	1		1	2	0	2	0	0
	SPU	21	4	17		21	1	1		1	1	1	0	0	0
E. coli	BAL	8	6	2		8	0				1	1	0	0	0
	SPU	25	6	19		25	1	1		1	2	1	0	0	1
H. influenzae	BAL	72	7	64	1	72	0				0
	SPU	91	4	85	2	91	2	1		1g	2	0	1	1	0
K. aerogenes	BAL	7	4	3	1	8	1		1	1	3	2	0	1	0
	SPU	9	3	6		9	1			0g	1	0	0	0	1
K. oxytoca	BAL	9	3	6		9	0				3	2	0	1	0
	SPU	10	3	7		10	0				1	0	0	0	1
K. pneumoniae group	BAL	12	7	5		12	0				1	1	0	0	0
	SPU	44	15	28		43	2	1		1h	2	1	0	0	1
M. catarrhalis	BAL	29	2	27		29	0				0
	SPU	70	1	68	1	70	0				1	1	0	0	0
Proteus spp.	BAL	4	3	1		4	0				0
	SPU	8	2	6		8	0				1	0	0	0	1
P. aeruginosa	BAL	38	19	19		38	0				4	3	0	0	1
	SPU	57	21	35	1	57	3	1		1g	7	5	0	1	1
S. marcescens	BAL	6	4	2		6	0				0
	SPU	27	7	19		26	1	1		1	4	2	0	0	2
S. aureus	BAL	70	29	38	2	69	1	1		1	6	5	1	0	0
	SPU	93	43	46	4	93	1	1		1	9	7	0	0	2
S. agalactiae	BAL	24	7	17		24	0				0
	SPU	34	5	29		34	0				0
S. pneumoniae	BAL	24	5	19		24	0				1	1	0	0	0
	SPU	35	1	34		35	0				3	1	0	1	1
S. pyogenes	BAL	6	2	4		6	0				0
	SPU	5	0	5		5	0				1	0	1	0	0
Total		875	220	639	13	872	16	9	1	10	59	34	7	6	12

^aSPU, sputum.

^bReported organism quantity in subject medical record. “Few” corresponds to values of <10,000 CFU/ml and the descriptions “few,” “1+,” “light growth,” “rare,” and “1 colony”; “Mod” corresponds to values of 10,000 to <100,000 CFU/ml and the descriptions “moderate,” “2+,” and “3+”; “Many” corresponds to values of ≥100,000 and the descriptions “many,” “heavy growth,” and “4+.” UQ, unable to quantify (quantity was given in relative terms, e.g., “listed first” or “least of three”).

^cBQ, organism present in qRefCx but enumerated below the quantification threshold of 10^3.5 (3,125) CFU/ml.

^dMolec, molecular.

^erTP, resolved true positive; evidence of organism presence confirming BioFire PN panel correct result.

^fcFN, confirmed false negative; evidence of organism presence confirming BioFire PN panel incorrect result.

^gIsolates misidentified by the central lab (see the text).

^hEvidence of specimen swap at central lab (see the text).