Intended Use

For IN VITRO diagnostic use in the automated, quantitative determination of Protein in Urine and Cerebrospinal Fluid (CSF).

 

Method Principle

Several methods have been described for the quantitative determination of Total Protein in urine and cerebrospinal fluid (CSF). Procedures utilizing dye-binding suffer from interferences making the protein assay inaccurate. Other procedures are time consuming, tedious and unsuitable for automated analysis. The Catachem Protein procedure for urine and CSF is based on the work of Wata I., Nishikaze O., subsequently modified by Richard W. Luxton et al. In this procedure benzathonium chloride reacts with protein to produce a homogeneous and stable turbidity. The procedure shows the same reactivity either with albumin or g-globulin. Interference from short peptides is not observed and interference from magnesium is prevented by the presence of EDTA in the Working Reagent.

 

Reagent Storage And Stability

Store the Catachem Base and Activator Urine CSF reagents at 2-8°C. When stored as directed these reagents are stable until expiration date stated on the label.

 

Working Reagent Preparation

Catachem Urine CSF Protein reagents are packaged in ready-to-use form. No preparation is required. For Working Reagents, open the required containers of Base and Activator reagents. Label the Base reagent “Working Reagent R1” and the Activator reagent “Working Reagent R2” Store these Working Reagents at 2-8°C. Upon opening and when stored as directed these Working Reagents are stable for 21 days.

Method Performance Characteristics

Sensitivity: Using a pathlength of 1 cm, a D-absorbance of 0.0016-0.0024 per mg/dl should be obtained.

Linearity: In this procedure there is not significant nonlinearity over the range of                   0-200 mg/dL (0-2000 mg/L).

Precision: Precision data was obtained using three levels of protein based controls and following the NCCLS EP5-T2 procedure (9). The following results were observed.

TO CONTACT US:

 

CATACHEM, INC.

955 Connecticut Avenue

Suite No. 4106

Bridgeport, CT  06607

 

Phone:     203-335-9277

Fax:         203-335-9977

 

Email:

catachem@catacheminc.com

 

URL:

www.catacheminc.com

Accuracy

Correlation studies were carried out between this automated Urine CSF Protein method (Y) and a reference automated Urine CSF Protein procedure based on the benzethonium chloride reactions (X). Samples were assayed and the results compared by the least square regression. The following statistics were observed: