Fastgen Corporation

Cardiac-3 Rapid Test

INTENDED USE:   The Cardiac-3 Rapid Test is intended for the in vitro diagnostic use in the qualitative  detection  of cardiac Troponin I, Myoglogin, and CK-MB in human serum samples.

Features and Advantages of Cardiac-3 Rapid Test

• Highly sensitive chromatographic immunoassay* detects the levels of all three critical cardiac markers for the diagnosis or exclusion of acute myocardial infarction (AMI)

• Incorporates measurement of CK-MB used in the WHO criteria for MI diagnosis

• Provides complete biochemical data in one test

• Rapid test format delivers results in minutes

*US FDA 510(K) approved pending 

Performance Characteristics

Cut-off positivity concentrations -	Troponin I	1.5 ng/ml
	Myoglobin	100 ng/ml
	CK-MB	7.0 ng/ml

• Accuracy

Troponin I

	Negative (0 ng/ml)	Troponin I (0.3-0.8 ng/ml)	Troponin I  (≥1.1 ng/ml)
# Samples	105	23	67
Negative	104	23	0
Position	10	0	67
Agreement	99.1%	100%	100%

Myoglobin

	Negative (0 ng/ml)	Myoglobin (13-66 ng/ml)	Myoglobin  (>100 ng/ml)
# Samples	70	50	101
Negative	70	42	0
Position	0	8	101
Agreement	100%	84%	100%

CK-MB

	Negative (0 ng/ml)	CK-MB (0.8-6.9 ng/ml)	CK-MB  (>7.5 ng/ml)
# Samples	79	30	58
Negative	79	26	0
Position	0	4	58
Agreement	100%	86.7%	100%

Product Information 

 in Acrobat (PDF)

Product Information 

 in Acrobat (PDF)

To Order

Catalog No. FGD0004    Cardiac-3 Rapid Test

Not available for sale in the US

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