Safety Data Sheet according to Regulation (EC) No 1907/2006 1. Identification of the substance/mixture and of the company/undertaking Doxycycline®, solid (Bulk), <=1% : Active ingredient: Doxicycline hyclate Doxycyclin® lyophylisate : Mixture for production of finished medicinal products. : Boehringer Ing. Pharma GmbH & Co.KG Binger Str. 173 55216 Ingelheim am Rhe
Nitrite: - Intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of
urinary tract infections of bacterial origin. The color test is based on the principle of the Griess reaction. Any degree of pink coloration should be interpreted as a positive nitrite test suggestive of ≥105 organisms/ml urine. For In-Vitro Diagnostic Use
Negative results do not exclude significant bacteriuria (insufficient incubation, urinary tract infections due to Urine Test Strips for the Rapid Determination of Ascorbic Acid, Bilirubin, Blood, Glucose, Ketones, Leucocytes, bacteria not containing nitrate reductase). Before testing the patient should ingest vegetable-rich meals, reduce Nitrite, pH-value, Protein, Specific Gravity and Urobilinogen. Refer to the carton and label for specific parameter fluid intake and discontinue antibiotic and vitamin C therapy 3 days prior to the test. False positive results combination on the product you are using.
may occur in stale urines, in which nitrite has been formed by contamination of the specimen and in urines containing dyes (derivatives of pyridinium, beetroot). A negative result even in the presence of bacteriuria Intended Use
can have the following reasons: bacteria not containing nitrate reductase, diet with low nitrate content, high diuresis, high content of ascorbic acid or insufficient incubation of the urine in the bladder. Red or blue borders For use as a preliminary screening test for diabetes, liver diseases, haemolytic diseases, urogenital and kidney or edges which may be present must not be interpreted as a positive result. Values of at least 0.05 – 0.1 mg/dl disorders and metabolic abnormalities.
(6.5 – 13 µmol/l) Nitrite are indicated.
Procedure and Notes
pH: - Intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of
• Use only well mixed, non-centrifuged urine, which should not be older than 4 hours. First morning urine is urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets. recommended. Protect the samples from light.
Persisting high pH-values indicate urinary tract infections. The test paper contains indicators which clearly • If the samples cannot be tested immediately, they should be stored at 2 – 4°C and brought to room change color between pH 5 and pH 9 (from orange to green to turquoise). The pH value of fresh urine of temperature (15 – 25°C) before testing.
healthy people varies between pH 5 and pH 6. Bacterial contamination may lead to false results. Red borders which may be present in neighbourhood to the nitrite field must not be taken into consideration The color fields • Collect specimen in clean, well rinsed containers, free of detergents. Do not add any preservatives.
correspond to the following pH values: 5, 6, 6.5, 7, 8, 9.
• Do not touch test areas of the reagent strip.
Protein: - Intended to identify proteins in urine. Identification of urinary protein is used in the diagnosis
• Immediately after removing the required number of strips, close the container securely using the original cap.
and treatment of renal diseases. The test is based on the „protein error“ principle of the indicator. The test is • Immerse the test strip in the urine (approx. 2 sec), so that all reagent areas are covered. Remove excess especially sensitive in the presence of albumin. Other proteins are indicated with less sensitivity. Normally, urine from the strip by wiping the edge of the strip on the urine container or on absorbent paper.
no protein is detectable in the urine of healthy subjects. Falsely positive results are possible in highly alkaline • To prevent interaction from adjacent test areas, hold the strip in a horizontal position during incubation.
urine samples (pH > 9) and in the presence of high specific gravity, after infusions with polyvinylpyrrolidone • Compare the reagent areas on the strip with the corresponding color chart on the container 60 seconds (blood substitute), after intake of medicaments containing quinine and also by disinfectant residues containing (60 – 120 seconds for leucocytes) after immersion. Coloration only on the rim of the test pad or after more quaternary ammonium groups in the urine sampling vessel. The color fields correspond to the following ranges than 2 minutes after immersion is without meaning and should not be used for interpretation.
of albumin concentrations: negative, 15(trace), 30, 100 and 500 mg/dl or negative, 0.15(trace), 0.3, 1.0 and • Visual evaluation should be carried out in diffuse daylight.
5.0 g/l. Values of approx. 15 mg/dl Albumine are indicated.
Specific Gravity / Density: - Intended to provide an estimation of renal ability of urine concentration or
Clinical Utility, Test Principles, Expected Values, Limitations
urine dilution. The specific gravity of urine varies in accordance with the drinking quantity as well as different Ascorbic Acid: - Intended to measure the level of ascorbic acid (vitamin C) in urine. The detection is based
disorders. A highly diluted urine e.g., a SG of approx. 1.000 can indicate a failure of the renal concentration on the decoloration of Tillmans reagent. In the presence of ascorbic acid a color change takes place from grey ability. In addition, the determination of specific gravity is also important indicator for a manipulation (e.g., urine blue to orange. Values of at least 5 – 10 mg/dl or 0.6 – 1.1 mmol/l are indicated.
dilution of sample) at the screening for drug abuse. The test is based on a color change of the reagent from blue green to greenish yellow depending on the concentration of ions in the urine. The test permits the determination Bilirubin: - Intended to measure the levels of bilirubin conjugates in urine. Measurements of urinary bilirubin
of urine density between 1.000 and 1.030. The normal value varies between 1.015 – 1.025. The color scale has and its conjugates are used in the diagnosis and treatment of certain liver and bile diseases. A red azo been optimized at a pH of the urine of 6. Highly alkaline (pH > 8) urines lead to slightly low results, highly acid compound is obtained in the presence of acid by coupling of bilirubin with a diazonium salt. Normally, no (pH < 6) urines may cause slightly higher results. Glucose and urea do not interfere. The color fields correspond bilirubin is detectable in urine. Concentrations of 0.5 mg/dl and more lead to a color of red-orange peach and to the values of 1.000, 1.005, 1.010, 1.015, 1.020, 1.025, 1.030.
indicate the early stage of a liver disease. The reaction is unaffected by pH of urine. False low or negative results may be simulated by large amounts of vitamin C or Nitrite or by longer exposure of the sample to direct Urobilinogen: - Intended to detect and estimate urobilinogen (a bile pigment degradation product of red
light. Increased concentrations of urobilinogen can reinforce the sensitivity of the test field. Different urine cell hemoglobin) in urine. Estimations obtained by this device are used in the diagnosis and treatment of contents (e.g. urine indicane) can lead to atypical coloration. For metabolites of drugs see urobilinogen. The liver diseases and hemolytic (red cells) disorders. The test is based on the coupling of urobilinogen with a color fields correspond to the following values: 0 (negative), 1(+), 2(++), 4(+++) mg/dl or 0 (negative), 17(+), stabilised diazonium salt to a red azo compound. The normal concentration of urobilinogen in urine goes from 35(++), 70(+++) µmol/l. Values of at least 0.5 – 1 mg/dl (8.5 – 17 µmol/l) Bilirubin are indicated.
0.1 – 1.8 mg/dl (1.7 – 30 µmol/l). Concentrations of > 2.0 mg/dl (35 µmol/l) are considered to be pathological. The reaction is unaffected by pH of urine. Higher concentrations of formaldehyde or exposure of the urine Blood: - Intended to detect occult blood in urine. Occult blood indicates serious urological or kidney diseases.
to light for a longer period of time may lead to lowered or falsely negative results. Beetroot or metabolites of Microhaematuria does not affect the colour of urine and is only detectable by microscopic or chemical tests. drugs which give a color at low pH (phenazopyridine, azo dyes, p-aminobenzoic acid) may cause false positive The detection is based on the pseudoperoxidative activity of hemoglobin and myoglobin, which catalyze the results. The color fields correspond to the following urobilinogen concentrations: norm. (normal), 2, 4, 8, oxidation of an indicator by an organic hydroperoxide and a chromogene producing a green color. Whereas 12 mg/dl or norm. (normal), 35, 70, 140, 200 µmol/l. Values of at least 1 – 2 mg/dl urobilinogen are indicated.
intact erythrocytes are reported by punctual colorations on the test pad, haemoglobin and myoglobin are reported by a homogeneous green coloration. The influence of ascorbic acid has been largely eliminated. Reagent Composition in the Tests
From a level at approx. 25 Ery/µl and above, even at high concentrations of ascorbic acid normally no negative Ascorbic acid: 2,6-dichlorophenolindophenol 0.7% results are observed. Falsely positive reactions can also be produced by a residue of peroxide containing cleansing agents, activities of microbial oxidase due to infections of the urogenital tract or by formaline. The Blood: tetramethylbenzidine-dihydrochloride 2.0%, isopropylbenzol-hydroperoxide 21.0% significance of a positive result varies from patient to patient. For establishing an individual diagnosis, it is Glucose: glucose oxidase 2.1%; peroxidase 0.9%; o-tolidine-hydrochloride 5.0% therefore indispensable to take into consideration also the clinical manifestations. The number of erythrocytes which are detected by sediment analysis may be lower than the result of the test strip, because lysed cells are Leucocytes: carboxylic acid ester 0,4%; diazonium salt 0.2% not detected by sediment analysis. The color fields correspond to the following values: 0 (negative), approx. Nitrite: tetrahydrobenzo[h]quinolin-3-ol 1.5%; sulfanilic acid 1.9% 5 – 10, approx. 50, approx. 300 Ery/µl. Values of approx. 5 Erythrocytes/µl are indicated.
pH: methyl red 2.0%; bromothymol blue 10.0% Glucose: - Intended to measure glucosuria (glucose in urine). Urinary glucose measurements are used in the
diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, and hyperglycemia. The detection is based on the glucoseoxidase-peroxidase-chromogen reaction. Apart from glucose, no other compound in urine is known to give a positive reaction. Normally, glucose cannot be detected in the urine Storage and Stability
although small amounts are secreted also by the healthy kidney. Changes in the coloration less than 50 mg/dl Keep diagnostic test strips protected from direct sunlight and humidity. Store the tubes in a cool and dry place (2.8 mmol/l) are to be considered normal. The influence of ascorbic acid has been largely eliminated. From (storage temperature 2 – 30°C). Under proper conditions test strips are stable up to the stated expiry date.
a glucose level at approx. 100 mg/dL (5.5 mmol/L) and above, even at high concentrations of ascorbic acid normally no negative results are observed. An inhibitory effect is produced by gentisic acid, a pH value of <5 and high specific gravity. False positive reactions can also be produced by a residue of peroxide containing • In order to establish a final diagnosis and prescribe an appropriate therapy, the results obtained with test cleansing agents or others. The color fields correspond to the following ranges of glucose concentrations: strips should be verified with other medical results.
normal, 50, 100, 250, 500 and 1000 mg/dl or normal, 2.8, 5.6, 14, 28 and 56 mmol/l. Values of at least • The effect of medicaments or their metabolic products on the test is not known in all cases. In case of doubt 40 mg/dl (2.2 mmol/l) glucose are indicated.
it is recommended not to take the medicaments and then repeat the test. However, stopping taking the drugs Ketones: - Intended to detect ketones in urine. Identification of ketones is used in the diagnosis and
should only be done after respective instruction of the doctor.
treatment of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition • Due to the fact that the content of the urine is not constant (e.g. content of activators or inhibitors which may characterized by increased production of ketone bodies) and for monitoring patients with diabetes. Acetone vary from sample to sample, changing ion concentration), the conditions of the reaction are not always the and acetoacetic acid react with sodium nitroprusside in alkaline solution to give a violet colored complex same which may lead to variations of the intensity and the color in rare cases.
(Legal‘s test). Normally the urine is free of ketones. Detectable concentrations of ketones can originate from • For reflectometric reading, please read carefully the detailed instructions for use of the instruments. As a physiological stress (fasting, pregnancy, excessive sport). Phenylketones in higher concentrations will produce result of the differing spectral sensitivities of the human eye and the optical system of the instruments, it is variable colors. β-Hydroxybutyric acid is not detected. Phthalein compounds and derivatives of anthrachinone not always possible to obtain precise agreement between the values obtained by visual reading and those interfere by producing a red coloration in the alkaline range which may mask the coloration of ketones. The color fields correspond to the following acetoacetic acid values: 0 (negative), 10(trace), 25(+), 100(++) and • For handling of the test strips, please observe the general working instructions for laboratories.
300(+++) mg/dl or 0 (negative), 1.0(trace), 2.5(+), 10(++) and 30(+++) mmol/l. Values of at least 5 mg/dl • For in vitro diagnostic use only. For trained staff only – not for self testing.
(0.5 mmol/l) acetoacetic acid or 50 mg/dl (8.6 mmol/l) acetone are indicated.
• Avoid swallowing and contact with eyes and mucous membranes. Keep away from children.
• Each laboratory should evaluate it’s own standards for quality control.
Leucocytes: - Intended to detect leucocytes in urine. Leucocytes indicate inflammatory diseases of the
• Literature: Thomas L.; Clinical Laboratory Diagnosis, TH-Books, Frankfurt/Main 1998 kidneys and the urinary tract, and suggests need for further investigation. The test is based on the esterase • Refer to the carton and label for package size.
activity of granulocytes. This enzyme splits heterocyclic carboxylates. The component released reacts with a diazonium salt producing a violet color. Urines of healthy subjects do not contain any leucocytes. Positive results, even when constantly varying from „negative“ to „25“, are to be considered as clinically relevant. Strongly = read package insert; = Expiry; = Store at; Do not reuse; colored compounds (e.g. nitrofurantoin) may disturb the color of the reaction. Glucose or oxalic acid in high = this product is conform to the directive 98/79EG dated 27. 10. 1998; concentrations, drugs containing cephalexine, cephalothine or tetracycline can lead to weakened reactions. = LOT Number; REF = catalogue number
Falsely positive results may be caused by contamination with vaginal secretion. The number of leucocytes which are detected by sediment analysis may be lower than the result of the test strip, because lysed cells are Analyticon® Biotechnologies AG
not detected by sediment analysis. The color fields correspond to the following values: 0 (negative), approx. 25, 35104 Lichtenfels, Germany
approx. 75, approx. 500 Leuko/µl. Values of at least 10 – 20 leucocytes/µl are indicated.
1) Alcohol is defined by what scheduled drug by F.S. Chapter 893 a) I b) II c) III d) IV e) Not scheduled 2) Evidence of use of alcohol is __________. a) empty or open alcohol cans or bottles nearby, smell of alcoholic beverage on clothes and breath, glassy, bloodshot, and watery eyes. b) crystals c) runny nose d) insomnia 3) What are the onset and duration of effects for orally drinking alcohol?