Cole Taylor Urine Test Parameter Bayer case Study

CardioChek LDL Cholesterol Test (25 strips)

LDL Direct test strip is only CLIA-waived LDL test available anywhere and works exclusively with the CardioChek PA. This strip can determine LDL (bad cholesterol) with NO PATIENT FASTING and is much less expensive than laboratory-based direct LDL tests.

$143.17/box** 25 strips/box
**

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Cole Taylor Urine Test Parameter Descriptions

Comparative Study on Clinitek Status
(Cole-Taylor (CTMI) & Bayer®)

With BIO-RAD LiquichekTM Urinalysis Control


Level 1 Lot No: 61291 Expiration Date: 4/2010
CONSTITUENT	REAGENT TEST STRIP RESULTS
	Cole-Taylor CTMI REAGENT STRIP (INSTRUMENT: BAYER Clinitek Status)		Bayer® REAGENT STRIP (INSTRUMENT: BAYER Clinitek Status)
	Control range Lot: 10SG80228 Exp: 9/2009		Bayer® REAGENT STRIP (INSTRUMENT: BAYER Clinitek Status)
	Control range Lot: 10SG80228 Exp: 9/2009		Control range Lot: 7K01C Exp: 4/2009
Bilirubin	Negative	Negative	Negative	Negative
Blood	Negative	Negative	Negative	Negative
Glucose	Negative	Negative	Negative	Negative
Ketone	Negative	Negative	Negative	Negative
Leukocytes	Negative	Negative	Negative	Negative
Nitrite	Negative	Negative	Negative	Negative
PH	5.0 - 6.5	6.0	5.5 - 6.5	6.0
Protein	Negative	Negative	Negative	Negative
Specific Gravity	1.010 - 1.020	1.015	1.010 - 1.020	1.015
Urobilinogen	0.2 – 1.0 EU/dL	0.2 EU/dL	0.2 – 1.0 EU/dL	0.2 EU/dL

Level 2 Lot No: 61292 Expiration Date: 4/2010
CONSTITUENT	REAGENT TEST STRIP RESULTS
	Cole-Taylor CTMI REAGENT STRIP (INSTRUMENT: BAYER Clinitek Status)		Bayer® REAGENT STRIP (INSTRUMENT: BAYER Clinitek Status)
	Control range Lot: 10SG80228 Exp: 9/2009		Control range Lot: 7K01C Exp: 4/2009
Bilirubin	Moderate - Large	Large	Moderate - Large	Large
Blood	Moderate - Large	Large	Moderate - Large	Large
Glucose	250 -1000mg/dL	500mg/dL	250 - 1000 mg/dL	500 mg/dL
Ketone	15 - 40 mg/dL	40 mg/dL	15 - 80 mg/dL	40 mg/dL
Leukocytes	Moderate - Large	Large	Small -Large	Large
Nitrite	Positive	Positive	Positive	Positive
PH	6.5 –7.5	7.0	7.0 - 8.0	7.0
Protein	100- >=300mg/dL	>=300 mg/dL	100 - 2000 mg/dL	>=300 mg/dL
Specific Gravity	1.010-1.025	1.025	1.020 – 1.030	1.020
Urobilinogen	4.0 – 8.0 EU/dL	4.0 EU/dL	4.0 – >=8.0 EU/dL	>=8.0 EU/dL


Bayer Strips vs CTMI Strips Using a CT-101
LEVEL 1
Control	Urine Strip	Glucose	Bilirubin	Ketone	Sp. Grav.	Blood	pH	Protein	Urobil.	Nitrites	Leukocytes
Biorad 1	Bayer	Negative	Negative	Negative	1.015	Negative	6.5	Negative	0.2	Negative	Negative
Biorad 1	CTMI	Negative	Negative	Negative	1.015	Negative	6.0	Negative	0.2	Negative	Negative
Level 2
Biorad 2	Bayer	3+	2+	3+	1.010	4+	7.5	3+	8.0	Positive	3+
Biorad 2	CTMI	2+	2+	2+	1.010	3+	8.0	2+	4.0	Positive	2+
Bayer Lot # 7K01C, Exp. 04-2009 CTMI lot #10SG70827 Exp. 03/2009 Biorad 1 Lot # 661281, Expires 10-31-2009 Biorad 1 Lot # 61292, Expires 4-30-2010
Patient ID	Urine Strip	Glucose	Bilirubin	Ketone	Sp. Grav.	Blood	pH	Protein	Urobil.	Nitrites	Leukocytes
1	Bayer	Negative	Small	Moderate	1.010	Negative	7.5	Trace	0.2	Positive	Small
1	CTMI	Negative	Negative	Moderate	1.010	Negative	7.0	Trace	0.2	Positive	Small
2	Bayer	Negative	Negative	Negative	1.010	Negative	6.0	Negative	0.2	Positive	Moderate
2	CTMI	Negative	Negative	Negative	1.010	Negative	6.0	Negative	0.2	Positive	Moderate
3	Bayer	Negative	Moderate	Negative	>=1.030	Negative	6.5	3+	0.2	Positive	Small
3	CTMI	Negative	Moderate	Negative	>=1.030	Negative	6.5	3+	0.2	Positive	Small
4	Bayer	Negative	Small	Negative	1.025	Negative	6.0	Trace	0.2	Positive	Negative Trace
4	CTMI	Negative	Moderate	Negative	>=1.030	Negative	6.0	Trace	0.2	Positive	Negative Trace
5	Bayer	Negative	Negative	Negative	1.025	1+	6.0	Negative	0.2	Negative Negative	Negative Negative
5	CTMI	Negative	Negative	Negative	1.025	1+	6.0	Negative	0.2	Negative Negative	Negative Negative
6	Bayer	Negative	Negative	Negative	1.010	1+	7.0	Negative	0.2	Negative Negative	Negative Negative
6	CTMI	Negative	Negative	Negative	1.010	1+	7.0	Negative	0.2	Negative Negative	Negative Negative
7	Bayer	Negative	Moderate	Small	>=1.030	Negative	6.0	Trace	0.2	Positive	Trace
7	CTMI	Negative	Small	Small	>=1.030	Negative	6.0	Trace	0.2	Positive	Trace
8	Bayer	Negative	Negative	Negative	1.010	Negative	7.5	Trace	0.2	Positive	Negative Trace
8	CTMI	Negative	Negative	Negative	1.010	Negative	7.5	Trace	0.2	Positive	Negative Trace
9	Bayer	Trace	Small	Negative	1.010	Negative	6.0	Trace	0.2	Positive	Negative Trace
9	CTMI	1+	Negative	Negative	1.015	Negative	6.0	Trace	0.2	Positive	Negative Trace
10	Bayer	Negative	Negative	Negative	<=1.005	Negative	6.0	Negative	0.2	Negative Negative	Negative Negative
10	CTMI	Negative	Negative	Negative	<=1.005	Negative	6.0	Negative	0.2	Negative Negative	Negative Negative

Bayer vs CTMI Using CT-101.xls Bayer vs CTMI Using CT-101.xls

LEVEL 1
Control	Urine Strip	Glucose	Bilirubin	Ketone	Sp. Grav.	Blood	pH	Protein	Urobil.	Nitrites	Leukocytes
Biorad 1	Bayer	Negative	Negative	Negative	1.015	Negative	6.5	Negative	0.2	Negative	Negative
Biorad 1	CTMI	Negative	Negative	Negative	1.015	Negative	6.0	Negative	0.2	Negative	Negative
Level 2
Biorad 2	Bayer	3+	2+	3+	1.010	4+	7.5	3+	8.0	Positive	3+
Biorad 2	CTMI	2+	2+	2+	1.010	3+	8.0	2+	4.0	Positive	2+
Bayer Lot # 7K01C, Exp. 04-2009 CTMI lot #10SG70827 Exp. 03/2009 Biorad 1 Lot # 661281, Expires 10-31-2009 Biorad 1 Lot # 61292, Expires 4-30-2010
Patient ID	Urine Strip	Glucose	Bilirubin	Ketone	Sp. Grav.	Blood	pH	Protein	Urobil.	Nitrites	Leukocytes
11	Bayer	Negative	Small	Trace	1.025	Negative	6.5	Trace	0.2	Negative Negative	Negative Negative
11	CTMI	Negative	Negative	Trace	1.025	Negative	6.0	Trace	0.2	Negative Negative	Negative Negative
12	Bayer	Negative	Negative	Negative	<=1.005	Negative	6.0	Negative	0.2	Negative	Small
12	CTMI	Negative	Negative	Negative	<=1.005	Negative	6.0	Negative	0.2	Negative	Small
13	Bayer	Negative	Negative	Negative	1.025	Negative	6.0	Negative	0.2	Negative	Small
13	CTMI	Negative	Negative	Negative	1.025	Negative	6.0	Negative	0.2	Negative	Small
14	Bayer	Negative	Negative	Negative	1.015	Large	5.0	Trace	0.2	Negative Negative	Negative Negative
14	CTMI	Negative	Negative	Negative	1.015	Large	5.0	Trace	0.2	Negative Negative	Negative Negative
15	Bayer	Negative	Negative	Negative	<=1.005	Negative	7.0	Negative	0.2	Negative Negative	Negative Negative
15	CTMI	Negative	Negative	Negative	<=1.005	Negative	7.0	Negative	0.2	Negative Negative	Negative Negative
16	Bayer	Negative	Small	Negative	1.010	Negative	7.5	Trace	0.2	Positive	Trace
16	CTMI	Negative	Small	Negative	1.015	Negative	7.5	Trace	0.2	Positive	Trace
17	Bayer	Trace	Small	Negative	>=1.030	Negative	6.0	Trace	0.2	Positive	Trace
17	CTMI	Trace	Small	Negative	>=1.030	Negative	6.0	Trace	0.2	Positive	Trace
18	Bayer	Negative	Negative	Negative	1.020	Negative	6.0	Negative	0.2	Positive	Negative Negative
18	CTMI	Negative	Negative	Negative	1.020	Negative	6.0	Negative	0.2	Negative	Negative Negative
19	Bayer	Negative	Negative	Negative	1.010	Negative	7.0	Negative	0.2	Negative Negative	Negative Negative
19	CTMI	Negative	Negative	Negative	1.010	Negative	7.0	Trace	0.2	Negative Negative	Negative Negative
20	Bayer	Trace	Negative	Negative	1.010	Negative	6.5	Trace	0.2	Positive	Trace
20	CTMI	1+

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