Lifesign 21000 - Status DS Control Set 2X5 mL

Lifesign 21000 - Status DS Control Set 2X5 mL

Status DS Control Set

Rapid Immunoassay For The Detection Of Cotinine, Nicotine Metabolite In Urine

• Simple test procedure
• 500 ng/mL cutoff level
• Detects active nicotine intake
• Helps to permit counseling and intervention immediately

Status DS Nicotine Intended Use

The Status DS Nicotine test is a simple, one-step, immuno-chromatographic assay for the rapid, qualitative detection of cotinine, a major metabolite of nicotine, at the cut-off of 500 ng/mL in human urine. Status DS Nicotine is used as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine. For In vitro Diagnostic Use.

The Status DS Nicotine test provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography, mass spectrometry (GC/MS) is the preferred confirmatory method.

Status DS Nicotine Summary and Explanation

Smoking has been identified as a major risk factor for lung cancer and cardiovascular disease.1,2 Self-reporting of smoking status is not reliable.3 The detection of cotinine, a major metabolite of nicotine, has become the preferredbiomedicalmethodof assessingthe smokingstatusofindividuals on account of its sensitivity and specificity.

Cotinine is present in blood, urine, and saliva of individuals who smoke or chew tobacco or who inhale tobacco smoke produced by others. As an objective indicator of nicotine intake or confirmation of nonsmoker status, cotinine offers several advantages over other biochemical measures: it is a specific indicator of nicotine intake, its concentrations are not influenced by confounding factors such as diet or environment, its average biological half-life inblood is19 hours, andits concentrationwithinagivenindividual varies by only 15 to 20% over the course of a day. Cotinine assay is thus a superior objective measure of exposure to nicotine.

Status DS Nicotine Principle

The Status DS Nicotine test uses solid-phase chromatographic membrane immunoassay technology for a qualitative detection of a nicotine metabolite, cotinine, in human urine. The test is based on the principle of the highly specific immunochemical reactions between antigens and antibodies which are used for the analysis of specific substances in biological fluids. The test relies on the competition to bind to the antibodies between the cotinine conjugate and cotinine that may be present in the urine sample. In the test procedure, a sample of urine is placed in the Sample well of the device and is allowed to migrate upward. If cotinine is present in the urine sample, it competeswith the cotinine conjugate,which is bound to the dye, for the limited antibodies immobilized on the membrane. If cotinine level is above the cutofflevel, cotininewillsaturate the antibodies, thusinhibiting the binding of the dye coated with cotinine conjugate to the antibodies on the membrane. This prevents the formation of a line on the membrane. Therefore, a cotinine-positive urine sample will not generate a line at the Test position (T) in the Result window, indicating a positive result from positive cotinine competition, while a negative urine sample will generate a line at the Test position in the Result window, indicating a negative result from an absence of competition with free cotinine.

In addition to the Test line that may appear at the Test position (T), a Control line is present at the Control position (C) to confirm the viability of the test. This Control line (validation line) should always appear if the test is conducted properly. This works as a procedural control, confirming that proper sample volume was used and the reagent system at the control lineandtheconjugate-colorindicatorworked.Ifinsufficientsamplevolume is used, there may not be a Control line, indicating the test is invalid.

Materials Provided

The Status DS Nicotine test kit contains all the reagents necessary to perform the assay.

• Status DS Nicotine device. The test device contains a membrane strip and a dye pad: The membrane strip is coated with monoclonal anti-cotinine antibody and the dye pad contains dye coated with cotinine-protein conjugate.
• Disposable specimen dispenser.
• Instructions for use.

Materials Needed but Not Provided

• Timer
• External positive and negative controls

Test Procedure

The test procedure consists of adding the urine sample to the Sample well of the device and watching for the appearance of colored lines in the result window.

• For each test, open one Status DS Nicotine pouch and label the Status device with the patient ID.
• Holding the dropper vertically, dispense 3 full drops (110 L) of the urine sample into the Sample well (S).
• Read the result after 5 minutes, but within 10 minutes of sample application.

Interpretation of Results

Negative: Two Lines. The appearance of two reddish-purple lines - one at the Test position ( T) and the other at the Control position ( C) in the Result window - indicates a negative test result; i.e., no cotinine above the cutoff level has been detected. The color of the Test line may be weaker or stronger than that of the Control line. A negative test result does not indicate the absence of cotinine in the sample; it indicates only that the sample does not contain cotinine above the cutoff level in qualitative terms.

Positive: One Line. The appearance of only one reddish-purple line at the Control position (C) in the Result window and no distinct line at the Test position (T) indicates the test result is positive (i.e., the specimen contains cotinine at a concentration above the cutoff level).

Invalid: A distinct colored line should always appear at the Control position ( C). The test is invalid if no line forms in the Control position ( C).

Status DS Nicotine test vs an EIA test