Description

INTENDED USE

ELITech Clinical Systems ANTI STREPTOLYSIN O is an in vitro diagnostic reagent intended for the quantitative determination of streptolysin-O (SLO) in human serum and plasma samples.

CLINICAL SIGNIFICANCE (1)

Streptolysin-O (SLO) is a toxin produced by ß-hemolytic streptococci of groups A, C and G.

Determination of SLO antibodies (ASLO or ASO) is used to help diagnose compli- cations following a group A streptococcal infection such as rheumatic fever or acute glomerulonephritis.

METHOD

Latex-enhanced immuno-turbidimetry – End Point.

PRINCIPLE

When anti-streptolysin O antibodies are present in the sample, they combine with recombinant streptolysin O-coated latex beads. These complexes precipitate leading to an increase of turbidity measured at 546 nm.

COMPOSITION

Reagent 1: R1

Buffer, pH 8.2

Proclin 0.1%

Reagent 2: R2

Latex particles coated with recombinant streptolysin O, pH 8.2 Proclin 0.1%

Calibrator: Cal

Lyophilized calibrator prepared from human serum. The value is lot-specific.

MATERIALS REQUIRED BUT NOT PROVIDED

• IRCT-0046 RHEUMATOLOGY CONTROL I
• IRCT-0047 RHEUMATOLOGY CONTROL II
• General Laboratory equipment.
• Do not use materials that are not required as indicated above.

PRECAUTIONS OF USE AND WARNINGS

• These in vitro diagnostic devices (reagent and calibrator) are for professional use only.

The reagents R1 and R2 are classified as hazardous :

WARNING:

May cause an allergic skin reaction. Wear protective gloves/protective clothing/eye protection/face protection. IF ON SKIN: Wash with plenty of soap and water. If skin irritation or rash occurs: Get medical advice/ attention. Take off contaminated clothing and wash it before reuse.

• The calibrator is prepared from human material tested by FDA or CE approved methods and found to be negative for HbsAg, anti-HCV antibody and anti-HIV1&2 antibodies. However as no test method can rule out the potential risk of infection with absolute certainty, handle cautiously as potentially infectious.
• For more information, refer to the Safety Data Sheet (SDS).
• Take normal precautions and adhere to good laboratory practice.
• Use clean or single use laboratory equipment only to avoid contamination.
• Do not interchange reagent vials from different kits.

STABILITY

Store at 2-8 °C and protect from light. Do not freeze. Do not use after expiration date indicated on the vial labels. On board stability of reagent:

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

Stability of calibrator after reconstitution:

Calibrator is stable for 1 month when stored at 2-8 °C or 3 months at -20°C.

PREPARATION

Reagent:

The reagents are ready to use. Before installation, gently shake R2 reagent.

Calibrator:

Carefully open the bottle avoiding loss of lyophilizate. Add exactly 1 mL of distilled water.

Carefully close the vial. Mix gently to avoid the formation of foam. Bring to room temperature for about 10 minutes before use.

PRODUCT DETERIORATION

• The reagent R1 is a clear liquid. R2 is a milky liquid.
• Any presence of particles or turbidity would be a sign of deterioration.
• Calibrator should be clear after reconstitution. Cloudiness would indicate deterioration.
• Do not use the product if there is visible evidence of biological, chemical or physical deterioration.
• Do not use the product if the damages of packaging might have an effect on the product performances (leakages, pierced vial).

SAMPLES(2)

Specimen

• Serum
• Plasma (Lithium heparin)
• 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 with presence of fibrin should be centrifuged before testing.
• 2 days at room temperature
• 8 days at 2-8°C
• 6 months at -20°C

REFERENCE VALUES (1,3)

Serum/plasma IU/mL

Children ≤ 240

Adults ≤ 250

ASO levels are age-dependent and change with geographic location and with the local frequency of streptococcal infections.

Note : The quoted range should serve as a guide only. It is recommended that each laboratory verifies this range or establishes a reference interval for the intended poulation

PROCEDURE

Manual Procedure Wavelength : 546 nm

Optical path : 1 cm Sample/reagent ratio : 1:45 Temperature: 37 °