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Products

Myoglobin Test
Myoglobin Whole Blood Test Cassette

Catalog No.                      SPECIMEN                       

ABT-CT-B68                    Whole Blood/Serum/Plasma


ACCU-TELL® Rapid Myoglobin Test Cassette (Whole Blood/Serum/ Plasma) is a rapid chromatographic immunoassay for the qualitative detection of human Myogobin in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI).ACCU-TELL® Rapid Myoglobin Test Cassette (Whole Blood/Serum/ Plasma) is a rapid chromatographic immunoassay for the qualitative detection of human Myogobin in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI).

Sensitivity and Specificity
ACCU-TELL® Rapid Myoglobin Test Cassette (Whole Blood/Serum/ Plasma) has been evaluated with a leading commercial Myoglobin EIA test using clinical specimens. The results show that relative to leading EIA tests, ACCU-TELL® Rapid Myoglobin Test Cassette (Whole Blood/Serum/Plasma) shows >99.9% sensitivity and 97.7% specificity for Myoglobin.
Myoglobin Rapid Test vs. EIA
Method                                                              Total Result
                             Positive              Negative 
 Positive                    104                     15                  119
 Negative                    0                      651                 651
Total Result              104                     666                 770
Relative sensitivity: 104/104=>99.9% (95%CI*: 97.2%~100.0%);
Relative specificity: 651/666=97.7% (95%CI*: 96.3%~98.7%);
Accuracy: (104+651)/(104+15+651)=98.1%(95%CI*: 96.8%~98.9%).
*Confidence Intervals
Precision
Intra-Assay
Within-run precision has been determined by using 15 replicates of below five specimens: Myoglobin specimen levels at 0 ng/mL, 50 ng/mL, 100 ng/mL, 200 ng/mL and 400 ng/mL. The specimens were correctly identified >99% of the time.
Inter-Assay
Between-run precision has been determined by 3 independent assays on the same five specimens: 0ng/mL, 50ng/mL, 100ng/mL, 200ng/mL and 400ng/mL of Myoglobin. Three different lots of ACCU-TELL® Rapid Myoglobin Test Cassette (Whole Blood/Serum/Plasma) have been tested using these specimens. The specimens were correctly identified >99% of the time.
Cross-reactivity
ACCU-TELL® Rapid Myoglobin Test Cassette (Whole Blood/Serum/ Plasma) has been tested by HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, syphilis, anti-HIV, anti-H.pylori, MONO, anti-CMV, anti-Rubella and anti-Toxoplasmosis positive specimens. The results showed no cross-reactivity.
Interfering Substances
The following potentially interfering substances were added to Myoglobin negative and positive specimens, repectively.
Acetaminophen:       20 mg/dL            Caffeine:          20 mg/dL
Acetylsalicylic Acid:  20 mg/dL            Gentisic Acid:  20 mg/dL
Ascorbic Acid:           20mg/dL            Albumin:    10,500mg/dL
Creatin:                  200 mg/dL           Hemoglobin 1,000 mg/dL
Bilirubin:              1,000mg/dL            Oxalic Acid:     600mg/dL
Cholesterol:           800mg/dL             Triglycerides: 1,600mg/dL
None of the substances at the concentration tested interfered in the assay.

1. ACCU-TELL® Rapid Myoglobin Test Cassette (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. This test should be used for the detection of Myoglobin in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in Myoglobin can be determined by this qualitative test.
2. ACCU-TELL® Rapid Myoglobin Test Cassette (Whole Blood/Serum/Plasma) will only indicate the qualitative level of Myoglobin in the specimen and should not be used as the sole criteria for the diagnosis of myocardial infarction.
3. ACCU-TELL® Rapid Myoglobin Test Cassette (Whole Blood/Serum/Plasma) cannot detect less than 50ng/mL Myoglobin in specimens. A negative result at any time does not preclude the possibility of myocardial infarction.
4. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
5. Some specimens containing unusually high titers of heterophile antibodies or rheumatoid factor (RF) may affect expected results. Even if the test results are positive, further clinical evaluation should be considered with other clinical information available to the physician.
6. There is a slight possibility that some whole blood specimens with very high viscosity or which have been stored for more than 2 days may not run properly on the test cassette. Repeat the test with a serum or plasma specimen from the same patient using a new test cassette.