Amylase Clinical Chemistry reagent, Elitech

Description

INTENDED USE

ELITech Clinical Systems AMYLASE SL is intended for the quantitative in vitro diagnostic determination of amylase in human serum and plasma.

CLINICAL SIGNIFICANCE

Amylase is an enzyme from pancreatic or salivary origin that hydrolyses 1,4-glucosidic bonds, thus helping for starch digestion. Analysis of serum amylase is mainly used in the diagnosis of the pancreatic diseases (acute or chronic pancreatitis and their complications, carcinoma). During acute pancreatitis, a transitory increase of serum amylase is observed, a peak corresponding to of 4 to 6-fold elevation being reached in 12 to 72h after the beginning, the activity returning to the normal after 3 to 5 days. However, a serum amylase increase is also observed in other intra-abdominal pathologies, renal insufficiency, ovary cancers, salivary gland lesions, acute alcoholism, renal insufficiency or macroamylasemia (presence of a complex amylase-IgG not filtered by the glomerulus).

• CONT-0060 ELITROL I 10 x 5 mL
• CONT-0160 ELITROL II  10 x 5 mL
• General Laboratory equipment.
• Normal saline solution (NaCl 9 g/L)
• Do not use materials that are not required as indi- cated above.

WARNINGS AND PRECAUTIONS

• This reagent kit is for professional in vitro diagnostic use only.
• Contact with acids liberates toxic gas.
• The reagent contains sodium azide which may react with lead or copper plumbing to form potentially explo- sive metal azides. When disposing of these reagents always flush with copious amounts of water to prevent azide buildup.
• Take normal precautions and adhere to good laboratory practice.
• Use clean or single use laboratory equipment only to avoid contamination.
• Saliva and sweat contain amylase. It is therefore recommended to wear gloves and a mask to avoid the contamination of the reagent.
• For more information, Safety Data Sheet (SDS) is available on request for professional user.

STABILITY OF REAGENTS

Store at 2-8 °C and protect from light. Do not freeze. Do not use after expiration dates indicated on the vial labels.

On board stability :

The on-board stability is specific for each analyzer. (Refer to § PERFORMANCE DATA).

PREPARATION

The reagent is ready to use.

REAGENT DETERIORATION

• The reagent solution should be clear. Cloudiness would indicate deterioration.
• Do not use the product if there is visible evidence of biological, chemical or physical deterioration.

DAMAGED PACKAGING

Do not use the reagent if the damages of packaging might have an effect on the product performance (leak- ages, pierced vial).

SAMPLES 

Specimen

• Serum
• Lithium heparinized plasma
• Do not use other specimens.

• Warnings and precautions

According to Good Laboratory Practice, sampling should be performed prior to the administration of drugs.

Storage and stability

Samples are stable 1 week at room temperature, 1 week at 2-8 °C and 1 year at -20 °C.

REFERENCE VALUES 

Serum, plasma (37 °C):   31-107 U/L