HCT-o-trol Extend is an assayed control designed to monitor values obtained from automated, semi-automated and manual methods. Please refer to the assay table for specific instrument models.
SUMMARY AND PRINCIPLE
It is an established laboratory practice to use a stable control to monitor the performance of diagnostic tests. This control is composed of stable materials that provide a means of monitoring the performance of automated, semi-automated and manual hematocrit methods. It is sampled in the same manner as a patient specimen.
HCT-o-trol Extend is an in vitro diagnostic reagent composed of human erythrocytes suspended in a plasma-like fluid with preservatives.
HCT-o-trol Extend is intended for in vitro diagnostic use only by trained personnel.
WARNING: POTENTIALLY BIOHAZARDOUS MATERIAL.
For in vitro diagnostic use. Each human donor/unit used in the preparation of this product has been tested by a FDA licensed method/test and found to be negative or non-reactive for the presence of HBsAg, Anti-HCV, NAT testing for HIV-1, HCV (RNA) and HIV-1/2. Each unit is also negative by a serological test for Syphilis (RPR or STS). Because no test method can offer complete assurance that infectious agents are absent, this material should be handled as potentially infectious. When handling or disposing of vials follow precautions for patient specimens as specified in the OSHA Bloodborne Pathogen Rule (29 CFR Part 1910, 1030) or other equivalent biosafety procedures.
STABILITY AND STORAGE
Store HCT-o-trol Extend vials upright at 2 ‑ 8° C (35 ‑ 46° F) when not in use. Protect vials from overheating and freezing. Unopened vials are stable through the expiration date. Opened vials are stable for 21 days, provided they are handled properly.
INDICATIONS OF DETERIORATION
After mixing, product should be similar in appearance to fresh whole blood. In unmixed vials, the supernatant may appear cloudy and reddish; this is normal and does not indicate deterioration. Other discoloration, very dark red supernatant or unacceptable results may indicate deterioration. Do not use the product if deterioration is suspected.
INSTRUCTIONS FOR USE
Remove vials from the refrigerator and allow to warm to room temperature (15 - 30° C or 59 - 86° F) for 15 minutes before mixing.To mix, hold a vial horizontally between the palms of the hands. Do not pre-mix on a mechanical mixer.Roll the vial back and forth for 20 - 30 seconds; occasionally invert the vial. Mix vigorously, but do not shake. Continue to mix in this manner until the red cells are completely uspended. Vials stored for a long time may require extra mixing. Gently invert the vial 8 - 10 times immediately before sampling. Analyze the sample as instructed in the Quality Control section of the Operator's Manual for your instrument. After sampling:Clean residual material from the cap and vial rim with a lint-free tissue. Replace the cap tightly.
Verify that the lot number on the vial matches the lot number on the table of assay values. Assay values are determined on well-maintained, properly calibrated instruments using the instrument manufacturer’s recommended reagents. Reagent differences, maintenance, operating technique, and calibration may contribute to inter-laboratory variation.
Assigned values are presented as a Mean and Range. The Mean is derived from replicate testing on instruments operated and maintained according to the manufacturer's instructions. The Range is an estimate of variation between laboratories and also takes into account inherent imprecision of the method and expected biological variability of the control material.Assay values on a new lot of control should be confirmed before the new lot is put into routine use. Test the new lot when the instrument is in good working order and quality control results on the old lot are acceptable. The laboratory’s recovered mean should be within the assay range.For greater control sensitivity each laboratory should establish its own mean and acceptable range and periodically reevaluate the mean. The laboratory range may include values outside of the assay range. The user may establish assay values not listed on the Assay Sheet, if the control is suitable for the method.
The performance of this product is assured only if it is properly stored and used as described in this insert. Incomplete mixing of a vial prior to use invalidates both the sample withdrawn and any remaining material in the tube.
TECHNICAL ASSISTANCE AND CUSTOMER SERVICE
For technical assistance or additional information, please call your dealer or local distributor. If there is no, you may call BGT Service at 02551/4090.
QUALITY CONTROL PROGRAM
For information on the Inter-Laboratory Quality Control Program, please call BGT Service at 02551/4090.
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