1.0 Intended Use
Biotron Diagnostics CK-MB Isoenzyme Control has been
assayed for CK-MB and is intended to be used as a human serum control product
for CK-MB.
2.0 Summary and Principle
The determination of the content of the CK-MB
isoenzyme is a valuable diagnostic tool in the evaluation of many pathological
conditions, including acute myocardial infarction. These controls are designed for use in both
manual and automated systems. The use of
control material is necessary to estimate test precision in a test system and
to detect systematic analytical deviation that may arise from reagent or
analytical instrument variation. These
control levels are available for the clinical laboratory to evaluate the
patient CK-MB isoenzyme level in normal and abnormal conditions. Since King Diagnostic controls consist of an
all human preparation, they can be run side by side with the patient sample
through all phases of the test method.
These human controls eliminate possible altered values found in
non-human based materials.
3.0 Reagent
Biotron Diagnostic CK-MB Isoenzyme Controls are
prepared from human serum and human derived isoenzyme and are available in two
levels. This product is freeze-dried for
extended shelf life.
3.1 Reagent
Storage
CK-MB Isoenzyme Controls are stable until the date
indicated on the vial when stored at 2-8°C.
Reconstituted vials are stable for seven days when
stored at 2-8°C. If turbid or gross
contamination appears after reconstitution, discard immediately.
3.2 Warning
Check the range of isoenzyme values specific for the
lot number of control being used.
These products have been found to be non-reactive
for Hepatitis B Surface Antigen (HBsAg) and negative for antibody to Human
Immunodeficiency Virus (HIV), when tested by the FDA approved third generation
methods. No known methods for HBsAg and
HIV can offer total assurance that products derived from human blood will not
transmit these diseases. Therefore,
human serum products and patients samples should be considered potentially
hazardous and handled as if capable of transmitting infectious agents.
Caution: control material contains azides which can
react with copper or lead plumbing to form explosive azides.
After use, flush with copious amounts of water to
prevent azide build up.
4.0 Procedure
4.1 Remove vials from refrigerator and
allow to warm to room temperature for 15 to 20 minutes.
4.2 Remove the seal and rubber stopper
from vials. Volumetrically add exactly
3.0 ± 0.05ml of distilled or deionized water using a calibrated pipet. The water used for reconstitution should be
at room temperature, 18-26°C.
4.3 Recap the vial and gently swirl 10
times.
4.4 Let the vials remain at room
temperature for 20 minutes, then invert gently 10 times.
4.5 Let the vials remain at room
temperature for an additional 20 minutes.
Then invert 10 times and gently swirl.
4.6 Use immediately or refrigerate at 2-8°C for future use.
5.0 Limitations
5.1 Biotron Diagnostic CK-MB controls
have been evaluated using the Biotron Diagnostic CK-MB reagent.
5.2 Each lot of control has its own
determined value.
5.3 Individual labs may not obtain the
mean values as listed for each lot.
Technique, equipment and experimental error may produce slightly
different values, however, the values should fall within the expected
range. Each laboratory should determine
their own mean values for this product.
6.0 Expected Results
See attached sheet for expected ranges.
7.0 Technical Support
Call Biotron at 1-800-595-8766 for technical service.
Recorder : Cat No 103045 (4x3ml)
8.0 Reference
8.1 Gerhardt W., et. al. Clin Chem
Acta78: 29, 1977
8.2 Giegel J.L., et. al. Clin Chem 28:
1364, 1982
8.3 Mercer D.W., Clin Chem 20: 36, 1974
8.4 Neumerier D., et. al. Clin Chem Acta
73: 445, 1976
8.5 Roberts R., et. al. The Lancet 319,
1977
8.6 Vaidya H.C., et. al. Clin Chem 32:
657, 1986
8.7 Wicks R.W., et. al. Clin Chem 28: 54,
1982
8.8 Willerson J.T., et. al. Proc Natl
Acad Sci USA 74: 1711, 1977