Quality Control of Reagents

4. Quality Control of Reagents

• The oldest reagents should be used first (first-in-first-out)
• There should be a system for indicating when supplies run low
• Every new lot of reagents should be evaluated for potency and specificity. All the results should be recorded.
• A low potency, contaminated or defective reagent should neva be used.

1. All reagents should be clearly labelled with batch number, expiry date and storage temp; instructions for use should be enclosed with each reagent packing.
2. All reagents & kit should be used according to the manufacturer’s instructions.
3. Use of positive & negative controls should be done with each batch to show that reagents are potent and specific.
4. All reagents must be carefully stored at recommended temp. Reagents to be kept at 4-6^oC should never be frozen and are stored according to manufacturer’s instructions only
5. All reagents must be of high quality and have a shelf-life of at least one year.
6. Supply, storage and transporation of kits and reagents should be strictly standardized & manufacturer’s instructions should be followed with ensured continuous power supply and periodic temperature monitoring.
7. All the reconsfituted reagents should be stored and reused according to manufacturer’s instructions.
8. If a reagent produces results outside the limits set by the manufacturer, the deficiency should be reported to the manufacturer.
9. Reagent records should include:
   • The name of each reagent with lot number, batch number, expiry date and name of manufacturer
   • Grade and strength of reactions.