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Example of a Completed Data Summary with Criteria for a Qualitative Study

Example 1 - Data Submitted for Multiple Foods

This method is applicable to the enumeration of Salmonella species in the following foods: raw meat (pork and poultry), processed meat (smoked ham), dairy (raw milk), egg products (whole shell egg and dried egg products), and fruit and vegetables (cantaloupe, bean sprouts, and spinach).

Note: While this method is only approved for certain food products and animal feeds, as listed above, it is assumed that this method can be used with other commodities. It is imperative that the Laboratory Supervisor ensures that proper validation is completed for other commodities to fulfill SCC accreditation requirements. It is requested that these validation data be forwarded to Don Warburton so the "Application Section" can be expanded to include these new categories.

Food Category	Sample Information			Actual Data (new method compared to standard method)					Calculated Criteria
Food Category	Food Type	Contaminating Microorganism¹	NC or AC? CFU or MPN/g (needed for artificially contaminated)	Total Tested	Positive	Negative	False Positive	False Negative	Sensitivity (≥98%)	Specificity (≥90.4%)	FP Rate (<9.6%)	FN Rate (<2%)	Test Efficacy (≥94%)
Application for multiple foods				(Application approved for raw meat (pork and veal), processed meat (smoked ham), dairy (raw milk cheese), egg products ( whole shell egg, and dried egg products), and fruit and vegetables (cantaloupe, bean sprouts, and spinach) as the other food types need more work; yellow below shows areas not meeting HC criteria)
Raw meat	Pork	Salmonella	NC	113	82	30	1	0	100	96.8	3.2	0	99.1
	Beef	Salmonella	NC	50	19	31	0	0	100	100	0	0	100
	Veal	Salmonella	NC	103	62	40	0	1	98.4	100	0	1.6	99
Processed meat	Smoked ham	Salmonella	NC	30	20	10	0	0	100	100	0	0	100
	Pepperettes	Salmonella	NC	94	79	9	0	0	100	100	0	0	100
	Lunch meats	Salmonella	NC	105	69	34	0	2	97.2	100	0	2.8	98.1
Dairy	Raw milk cheese	Salmonella	NC	140	83	48	6	3	96.5	88.9	11.1	3.5	93.6
	Ice cream	Salmonella	NC	141	10	129	1	1	90.9	99.2	0.8	9.1	98.6
	Raw milk	Salmonella	NC	114	75	38	1	0	100	97.4	2.6	0	99.1
Animal feed	Dog food	Salmonella	NC	76	69	5	0	2	97.2	100	0	28.6	97.4
	Hog feed	Salmonella	NC	86	69	5	2	10	87.3	71.4	28.6	12.7	86
	Chicken feed	Salmonella	NC	118	83	33	0	2	97.6	100	0	2.4	98.3
Egg products	Raw liquid egg	Salmonella	NC	101	69	30	0	2	97.2	100	0	2.8	98
	Whole shell egg	Salmonella	NC	56	21	35	0	0	100	100	0	0	100
	Dried Egg products	Salmonella	NC	79	66	12	1	0	100	92.3	7.7	0	98.7
Fruits and vegetables	Cantaloupe	Salmonella	NC	151	22	129	0	0	100	100	0	0	100
	Bean sprouts	Salmonella	NC	102	62	39	0	1	98.4	100	0	1.6	99
	Spinach	Salmonella	NC	162	60	100	1	1	98.4	99	1	1.6	98.8

¹ Contaminating microorganism: if artifically contaminated then the ID of the inoculating organism must be supplied. If naturally contaminated, supply serotype if available.

DISCLAIMER: This table is a fictitious example of a part of a data submission and is NOT meant to be representative of true data.

Example 2 - Application for One Food Commodity

This method is applicable to the enumeration of Salmonella species in the following dairy products: yogurt and raw milk cheese.

Note: While this method is only approved for certain dairy products, as listed above, it is assumed that this method can be used with other dairy products as well as other commodities. It is imperative that the Laboratory Supervisor ensures that proper validation is completed for other commodities to fulfill SCC accreditation requirements. It is requested that these validation data be forwarded to Don Warburton so the "Application Section" can be expanded to include these new categories.

Food Category	Sample Information			Actual Data (new method compared to standard method)					Calculated Criteria
Food Category	Food Type	Contaminating Microorganism¹	NC or AC? CFU or MPN/g (needed for artifically contaminated)	Total Tested	Positive	Negative	False Positive	False Negative	Sensitivity (≥98%)	Specificity (≥90.4%)	FP Rate (<9.6%)	FN Rate (<2%)	Test Efficacy (≥94%)
Application for one food commodity				(Application approved for Ayogurt and raw milk cheese as the other food types need more work; yellow below shows areas not meeting HC criteria)
Dairy	Ice cream	Salmonella Berta	AC 1 CFU/25	89	59	30	0	0	100	100	0	0	100
	Raw milk	Salmonella	NC	76	69	5	0	2	97.2	100	0	2.8	97.4
	Processed cheese	Salmonella Infantis	AC 1.2 CFU/25	82	75	6	1	0	100	85.7	14.3	0	98.8
	Dry skim milk powder	Salmonella Senftenberg	AC 0.4 CFU/25	118	83	33	0	2	97.6	100	0	2.4	98.3
	Yogurt	Salmonella Agona	AC 3 CFU/25	79	66	42	1	0	100	97.7	2.3	0	99.1
	Ice milk	Salmonella Heidelberg	AC 1 CFU/25	118	83	33	0	2	97.6	100	0	2.3	98.3
	Cream cheese	Salmonella	NC	133	98	33	0	2	98	100	0	2	98.5
	Raw milk cheese	Salmonella	NC	162	60	100	1	1	98.4	99	1	1	98.8

¹ Contaminating microorganism: if artifically contaminated then the ID of the inoculating organism must be supplied. If naturally contaminated, supply serotype if available.

DISCLAIMER: This table is a fictitious example of a part of a data submission and is NOT meant to be representative of true data.