5,736,408; 6,468,805, 5,753,451 and other U.S. and Foreign Patents and
Patents Pending

Sciteck Diagnostics, Inc. Asheville, NC 28704
(800) 905-4272 Fax: (828) 650-2735 Outside USA: (828) 650-0409

www.sciteck.org


pH Reagent Assay


Methodology:
The pH Reagent Assay is a universal reagent system intended for use with the Olympus, Hitachi, Monarch and
other automated systems for the analysis of pH in urine. The analysis is based on an indicator principle that gives
a change in absorbance throughout the urinary pH range. A sample of urine is mixed with the reagent and,
depending on the hydrogen ion concentration of the urine, the indicator will exhibit a change in color. This color
change results in an absorbance that is monitored by a detector at 600 nanometers. All abnormal results should
be rechecked by a reference method.

All urines collected should be handled as potentially infectious

Reagent Materials Information:
Description: pH Reagent
Catalog #: 203-30
Quantity: 900 mL
Ingredients: Indicator, Stabilizer, Surfactant and Bacterial Inhibitors
Description: pH Cals 4.5 & 9.0
Catalog #: 107
Quantity: 2 x 60 mL
Ingredients: Buffer and Bacterial Inhibitors
Description: pH Cals 5.0 & 8.0
Catalog #: 109
Quantity: 2 x 60 mL
Ingredients: Buffer and Bacterial Inhibitors
Kit Materials Information:
Catalog # 203-30K contains pH Reagent (Catalog # 203-30) and pH Calibrators 4.5 and 9.0 (catalog # 107)
Reagent Preparation, Storage and Stability:
pH reagent kits, including buffers, are ready for use upon receipt. Store the pH reagent and buffers refrigerated at
2° to 10°C and do not freeze. The pH reagent and buffers are stable until the expiration date on the bottle label.
The pH buffers may be used as calibrators and/or controls.
Quality Control:
Every laboratory should establish its own acceptable ranges for quality assurance. Clinical diagnostic and
therapeutic decisions should not rely on the single value of any one assay. A confirmation of a result that has
diagnostic implications should be run by a different methodology. The pH assay has no known interfering
substances.
Specificity, Limitations, and Interferences:
pH values are not affected by variations in urinary buffer concentrations or urinary constituents. This assay is
intended for use with a urine matrix.

Specific Gravity Reagent Assay
Methodology:
The specific gravity assay is intended for use as a screening tool for determining urine specific gravities on
Olympus, Hitachi, Monarch and other automated systems for the analysis of urine. The analysis is based on an
indicator principle that gives a broad range of colors throughout the urinary specific gravity range (1.000 to 1.035).
A sample of urine is mixed with the reagent and, depending on the specific gravity (ionic strength) of the urine, the
indicator will exhibit a change in color. This color change results in a change in the absorbance that is monitored
by a detector at 600 nanometers. All abnormal results should be rechecked by a refractometer.

All urines collected should be handled as potentially infectious


Reagent Materials Information
Description: Specific Gravity Reagent

Catalog #: 117
Quantity: 825 mL
Ingredients: Indicator, Stabilizer, Surfactant and Bacterial Inhibitors
Description: Specific Gravity Cals 1.005 & 1.030
Catalog #: 118
Quantity: 2 x 60 mL
Ingredients: Synthetic Urinary constituents, Buffer and Bacterial Inhibitors
Description: Specific Gravity Cals 1.030 Catalog #: 118
Quantity: 1 x 60 mL
Ingredients: Synthetic Urinary constituents, Buffer and Bacterial Inhibitors
Description: Specific gravity Cals 1.020
Catalog #: 118
Quantity: 1 x 60 mL
Ingredients: Synthetic Urinary constituents, Buffer and Bacterial Inhibitors
Kit Materials Information:
Catalog # 116 contains specific gravity Reagent (Catalog # 117) and specific gravity Calibrators 1.005 and
1.030 (catalog # 118)
Reagent Preparation, Storage and Stability:
Specific gravity reagent and calibrators are ready for use upon receipt. Store the specific gravity reagent and
calibrators at 2-10°C. The reagents and calibrators are stable until the expiration date listed on the bottle label.
Quality Control:
Every laboratory should establish its own acceptable ranges for quality assurance. Clinical diagnostic and
therapeutic decisions should not rely on the single value of any one assay. A confirmation of a result that has
diagnostic implications should be run by a different methodology.
Specificity, Limitations, and Interferences:
The following values are given as normal ranges, but are intended as a guide only. Random urine: 1.003 - 1.030
specific gravity units. Highly buffered acidic or alkaline urines, urines with abnormal pH values outside pH 5.0 and
pH 8.0, and urines containing elevated amounts of urinary constituents may cause fluctuations in readings as with
other methods.

Creatinine Reagent Assay

Methodology
Most methods for determining creatinine are based on the Jaffe reaction. The creatinine assay is intended for
determining urine and/or serum creatinines on Olympus, Hitachi, Monarch and other automated systems for the
analysis of urinary or serum creatinine. This is the only FDA cleared creatinine assay the can be used for serum
or urine and has a linearity range for urine from 0 to 400 mg/dL. In this reaction, creatinine interacts with alkaline
picrate to form a reddish-yellow solution that is measured photometrically. This method is non-specific for
creatinine, because other substances in urine also react with alkaline picrate. This method is a modified Jaffe
method, with improved specificity over the original Jaffe procedure. Urine creatinine values, as well as
appearance and specific gravity, are useful as an adjunct in detecting diluted urine samples.

All urines collected should be handled as potentially infectious

Reagent Materials Information (
REAGENTS FOR URINE/SERUM ASSAY):
Description: Creatinine R(1) & R(2)
Catalog #: 139-30
Quantity: R(1) 750 mL & R(2) 150 mL
Ingredients: R(1) NaOH & R(2) Picric Acid
Description: Creatinine R(1)
Catalog #:139-30
Quantity: R(1) 750 mL
Ingredients: NaOH
Description: Creatinine R(2)
Catalog #:139-30
Qauntity: R(2) 150 mL
Ingredients: Picric acid
Description: Creatinine Cal 20 mg/dL
Catalog #:132-01
Quantity: 1x 60 mL
Ingredients: Creatinine and bacterial inhibitor
Description: Creatinine Cal 100 mg/dL Catalog #:136-01
Quantity: 1x 60 mL
Ingredients: Creatinine and bacterial inhibitor
Description: Creatinine Cal 400 mg/dL Catalog #:137-01
Quantity: 1x 60 mL
Ingredients: Creatinine and bacterial inhibitor
Note: For analyzing serum, use commercially available creatinine calibrators and controls.
Precautions:
DANGER: R1 Reagent contains sodium hydroxide. This reagent will irritate eyes, skin, and mucous membranes.
It may be harmful if swallowed.
WARNING: R2 Reagent contains picric acid. This reagent may irritate eyes, skin, and mucous membranes. It
may be harmful if swallowed or absorbed through the skin. For both reagents, avoid contact with eyes, skin, or
clothing. Do not pipet by mouth or ingest. Do not inhale vapors or mists of these materials. Wash thoroughly after
handling.

Preparation of Working Reagents:
NaOH R1, picric acid R2, and calibrator solutions are ready for use upon receipt. No reagent preparation is
necessary.
Reagent Stability, Storage, and Deterioration:
Open R1 and R2 working solutions are stable for at least four weeks when stored at 2-10ºC. Discard the NaOH
R1 or picric acid R2 if precipitates or turbidity are visible. Reagents and calibrators are stable until expiration date
on container.
Quality Control:
Good laboratory practices include the use of high and low quality control specimens in a true or synthetic urine
matrix, to ensure kit performance. These controls should be assayed routinely with every run.

Specificity, Limitations, and Interferences:
This method is linear up to 400 mg/dL creatinine in urine. Specimens with higher concentrations of creatinine
should be re-assayed after dilution with physiological saline. Young, et al, give a list of substances and conditions
known to affect creatinine levels IN VIVO.

Halogen Reagent Assay

Methodology:
Halogen(s) include, but are not limited to, Chlorine (Bleach) and Bromine. When present, halogens react with the
reagent containing a substituted biphenyl compound to yield a color complex which is read on an automated
analyzer, or manually, at 660 nm. Solutions of household bleach (which typically contain 5.25% or 5.25 gm
hypochlorite/100 mL) at concentrations of 1%, 5%, and 10% (v/v), contain the quantity of hypochlorite shown
below and the corresponding amount (in µL's) of bleach that when added to a sample yields these concentrations:

Concentrations of Hypochlorite (Bleach) (5.25%)
1%
= 0.525 mg/mL
= 10 µL/mL
5%
= 2.625 mg/mL
= 50 µL/mL
10%
= 5.250 mg/mL
= 100 µL/mL

All urines collected should be handled as potentially infectious

Reagents:
Description: Halogen Reagent

Catalog #: 400
Quantity: 1 x 500 mL
Ingredients: Halogen indicators, buffer and stabilizers
Description: Halogen Calibrator (1.0%)
Catalog #: 400-01
Quantity: 1 x 60 mL
Ingredients: Chlorine, buffers and stabilizers
Description: Zero Calibrator

Catalog #: 214-01
Quantity: 1 x 60 mL
Ingredients: Buffers and stabilizers
Description: Halogen Calibrator (10%)
Catalog #: 400-02
Quantity: 1 x 60 mL
Ingredi