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Accu-Tell® Myoglobin Rapid Test Cassette (Whole Blood/Serum/Plasma)

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Accu-Tell® Myoglobin 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). The minimum detection level is 50ng/mL.
Product Description

CATALOG

Product NameSpecimenCatalog No.Quantity per boxCertificate
Myoglobin   Cassette        Whole   Blood/Serum/PlasmaABT-CT-B6840T/20TCE


KEY POINTS

Detection for: human Myogobin in whole blood, serum or plasma

Reading time: 10 minutes

Minimum Detection Level: 50 ng/ml

Relative Sensitivity: >99.9%

Relative Specificity: 97.7%

Accuracy: 98.1%

 

INTRODUCTION

Myoglobin (MYO) is a heme-protein normally found in skeletal and cardiac muscle with a molecular weight of 17.8kDa. It  constitutes about 2 percent of total muscle protein and is responsible with transporting oxygen within the muscle cells. When the muscle cells are damaged, Myoglobin is released to the blood rapidly due to its relatively small size. Following the death of tissue associated with MI, Myoglobin is one of the first markers to rise above normal levels. The level of Myoglobin increases measurably above baseline within 2-4 hours post-infarct, peaking at 9-12 hours and returning to baseline within 24-36 hours. A number of reports suggest the measurement of Myoglobin as a diagnostic aid in confirming the absence of myocardial infarction with negative predictive values of up to 100% reported at certain time periods after onset of symptoms.

 

INTENDED USE

ACCU-TELL® Myoglobin Rapid 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). The minimum detection level is 50ng/mL.

 

TEST PROCEDURE

Myoglobin Rapid Test 2.JPG

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it within one hour.

2. Place the cassette on a clean and level surface.

For Serum or Plasma specimen:

Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50 µL) to the specimen area, then add 1 drop of buffer (approximately 40 µL), and start the timer. See illustration below.

For Venipuncture Whole Blood specimen:

Hold the dropper vertically and transfer 3 drops of whole blood (approximately 75 µL) to the specimen area, then add 1 drop of buffer (approximately 40 µL), and start the timer. See illustration below.

For Fingerstick Whole Blood specimen:

To use a capillary tube: Fill the capillary tube and transfer approximately 75 µL of fingerstick whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer (approximately 40 µL) and start the timer. See illustration below.

3. Wait for the colored line(s) to appear. Read results at 10 minutes.  Do not interpret the result after 20 minutes.

 

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

ACCU-TELL® Myoglobin Rapid 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® Myoglobin Rapid Test Cassette (Whole Blood/Serum/Plasma) shows >99.9% sensitivity and 97.7% specificity for Myoglobin.

Myoglobin Rapid Test vs. EIA

MethodEIATotal Result
ACCU-TELL® Myoglobin Cassette (Whole Blood/Serum/Plasma)ResultsPositiveNegative
Positive10415119
Negative0651651
Total Result104666770

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® Myoglobin Rapid 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® Myoglobin Rapid Test Cassette (Whole Blood/Serum/Plasma) has been tested by Rheumatoid Factor(RF), HAMA ,HCV, 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.

  

LIMITATIONS

1. ACCU-TELL® Myoglobin Rapid 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® Myoglobin Rapid 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® Myoglobin Rapid 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. 

 

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.