Sickle-o-trol   

INTENDED USE
Sickle-o-trol  is intended to be used as a sickle cell control in testing for the presence of Hemoglobin S in solubility tests.

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 presence of sickling hemoglobins in solubility tests. It is sampled in the same manner as a patient specimen.

REAGENTS
Sickle-o-trol  is an in vitro diagnostic reagent composed of human erythrocytes suspended in a plasma-like fluid with preservatives.

PRECAUTION
Sickle-o-trol  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 (OSHA 29 CFR Part 1910.1030) or other equivalent biosafety procedures.

STABILITY AND STORAGE
Store Sickle-o-trol  upright at 2 ‑ 8° C (35 - 46 F) when not in use. Protect tubes from overheating and freezing. Unopened tubes are stable through the expiration date. Opened tubes are stable for 100 days, provided they are handled properly.

INDICATIONS OF DETERIORATION
After mixing, product should be similar in appearance to fresh whole blood.  In unmixed tubes, the supernatant fluid is expected to be dark in color; this is normal and does not indicate deterioration.
Unacceptable results may indicate deterioration. Do not use the product if deterioration is suspected.

INSTRUCTIONS FOR USE

1. Remove vials from the refrigerator and allow to warm to room temperature (15 - 30°C or 59 - 86°F) for 15 minutes before mixing.
2. To mix, hold a vial horizontally between the palms of the hands. Do not pre-mix on a mechanical mixer.
   a) Roll the vial back and forth for 20 - 30 seconds; occasionally invert the vial. Mix vigorously, but do not shake.
   b) Continue to mix in this manner until the red cells are completely suspended. Vials stored for a long time may require extra mixing.
   c) Gently invert the vial 8 - 10 times immediately before sampling.
3. Analyze the sample as instructed in the reagent test kit instructions.
4. After sampling:
   a) Clean residual material from the cap and vial rim with a lint-free tissue. Replace the cap tightly.
   b) Return vials to refrigerator within 30 minutes of use.

Unopened vials are stable until the expiration date. Opened vials are stable for at least 14 days provided they are handled properly.

LIMITATIONS
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 vial.

EXPECTED RESULTS
Sickle-o-trol  is designed to be handled in the same manner as a patient specimen.  Analyze the sample as instructed in the reagent test kit.  The positive control will appear as a cloudy turbid suspension as described in the reagent test kit instructions for use.  The negative control will appear as a nearly transparent solution as described in the reagent test kit instructions for use.

TECHNICAL ASSISTANCE AND CUSTOMER SERVICE
For assistance in resolving control recovery problems, please call Technical Service at 02551/4090. For additional information on BGT hematology controls and calibrators, or to place an order, call Customer Service at 02551/4090.

All brands and products are trademarks or registered trademarks of their respective companies.