KGST129-508

INTENDED USE
The Drog-o-test Morphine/Heroin/Opiate is a simple one step immonochromatographic assay for the rapid. qualitative detection of opiates and their metabolites such as codeine and heroin in urine The cutoff of the lest is 300 ng/ml of OP1   It is the same as the SAMHSA recommended assay cutoff

The Drog-o-test Morphine/Heroin/Opiate provides only a preliminary analytical result. A more specific alternative chemical method must be used in order lo obtain a confirmed analytical result. Gas chromatography, mass spectrometry (GC/MS) is the preferred method. Clinical considerations and professional judgment should be applied to any drag of abuse test result, particularly when preliminary positive results are used.

EXPLANATION OF THE TEST
Opioid analgesics comprise a large group of substances, which control pain by depressing the central nervous system. Morphine is the prototype compound of this group Morphine is excreted in the urine primarily as morphine-3-glucuronide while smaller amounts are excreted as unchanged free morphine and other metabolites It is also the major metabolic product of codeine and heroin Morphine is detectable in the urine for several days after an opiate dose.

The Drog-o-test Morphine/Heroin/Opiate 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 sensitivity is 300 ng/ml of OPI

MATERIALS PROVIDED
The Drog-o-test Morphine/Heroin/Opiate kit contains the following items to perform the assay:

1. Drog-o-test Morphine/Heroin/Opiate test device.
2. Instructions for use

MATERIALS REQUIRED BUT NOT PROVIDED

1. Specimen collection container.
2. Clock or timer

PRECAUTIONS

1. For professional in vitro diagnostic use only
2. Avoid cross contamination of urine samples by using a new urine specimen container for each urine sample
3. Urine specimens are potentially infectious Proper handling and disposal methods should be established according to good laboratory practices.
4. Do not eat or smoke while handling specimen in the laboratory.
5. The Drog-o-test Morphine/Heroin/Opiate device should remain in its original sealed pouch until ready for use.
6. Do not use the test if the pouch is damaged or the seal is broken.
7. Do not use the test kit after the expiration date

STORAGE AND STABILITY
The Drog-o-test Morphine/Heroin/Opiate kit should be stored at 4-30 °C in the original sealed pouch. The expiration date given was determined under normal laboratory conditions

SPECIMEN COLLECTION AND PREPARATION

1. Fresh urine specimens do not require any special handling or pretreatment
2. Specimens should be collected in a clean glass or plastic container.
3. If testing will not be performed immediately, specimens should be refrigerated.
4. Specimens should be brought to room temperature before testing.
5. Specimens containing precipitate may yield inconsistent test results. Such specimen must be clarified prior to assaying

PROCEDURE OF THE TEST

1. Remove the test strip from its foil pouch.
2. Add 3 to 4 drops (I 20 to 160 ul) of urine sample in a test tube as shown in Figure 1.
3. Holding the strip vertically, carefully dip it into the specimen. Do not immerse the snip past the maximum line (Figure 1)
4. Interpret test refills at 3 to 5 minutes

INTERPRETATION OF THE TEST

1. As The test kit begins to work, a color band will appear at the left section of the result window to show that the test is working properly. This band is Control Band
2. The right section of the result window indicates the test results. If another color band appears at the right section of the result window, this band is the Test Band

NEGATIVE: TWO COLOR BANDS
The appearance of two color bands within the result window indicates a negative test result. No OPI above the cut-off level has been detected The color of the Test band may be lighter or darker than that of the Control band.

POSITIVE: ONE COLOR BAND
The appearance of only one color band within the result window indicates the result is positive, i.e. the specimen contains OPI at a concentration above the cut-off level

INVALID:
A distinct color band should always appeal in the left section of the result window. The test is invalid if no color band forms in the left section of the result window

Note. A very faint band in the right section of the result window, visible in 5 minutes, indicates that the amount of OPI in the sample is rear or below the cut-off level of the test. The urine specimen should be retested. or confirmed with a more specific alternative method such as gas chromatography/mass spectrometry, before a positive determination is made

USER QUALITY CONTROL
Control standards are not supplied with this kit. however, it is recommended that a control be tested as good laboratory testing practice For information on how to obtain controls, contact BGT Technical Service. Before using a new kit with patient specimens, positive (cutoff and 25% more than cutoff level) and negative 25% below cutoff level) controls should be tested to confirm the test procedure, and to verify the tests produce the expected Q. C. results

LIMITATIONS

1. The test is designed for use with unadulterated human urine only.
2. There is a possibility that factors such as technical or procedural errors, as well as other substances in the urine temples may interfere with the test and cause erroneous results.
3. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the method of analysts If adulteration is suspected, the test should be repeated with a new sample.
4. A positive test result does not provide any indication of the level of intoxication or urinary concentration
5. The test results read after 5 minutes may not be consistent with the original reading obtained within the 5 minutes reading period The test must be read within 5 minutes of sample application
6. Certain medications containing opiate or opiates derivatives may produce a positive result in any chemical and immunological assay.

EXPECTED VALUES
The Drog-o-test Morphine/Heroin/Opiate is a qualitative assay The amount of drugs and metabolites present in the urine cannot be estimated by the assay. The assay results distinguish positive from negative samples A positive result indicates the sample contains OPI above the cutoff concentration.

PERFORMANCE CHARACTERISTICS AND COMPARISON STUDIES
The Drog-o-test Morphine/Heroin/Opiate has been shown to detect an average of 100 ng/ml or more of OPI metabolites in urine. The accuracy of the OPI was evaluated in comparison to a commercially available immunoassay. A total of 50 negative real patients urine samples (concentration of OPI range of O-220 ng/ml) and 50 positive real patients urine sample (concentration of OPI range of 300-1035 ng/ml) were tested by both procedures Complete agreement was observed in 100% of the samples All positive samples and part of the negative urine sample were confirmed by GC/MS.

PRECISION AND REPRODUCIBILITY STUDIES
The precision of the Drog-o-test Morphine/Heroin/Opiate assay was determined by carrying out the test with serially spiked OPI urine samples The four concentrations, of 0 ng/ml, at 25% from cutoff (225 ng/ml), at the cutoff (300 ng/ml) and +25% from the cutoff (375 ng/ml) were tested to challenge the precision of the test device A total of 50 tests were run at 0 ng/ml, 50 at 225 ng/ml, 200 at 300 ng/m! and 50 at 375 ng/ml A total of 350 tests were tested About 99% of the samples containing drug concentrations at or more than 25% over the cutoff level consistently showed positive results.

The reproducibility studies were carried out at three different sites The urine samples containing 0. 300 ng/ml and 900 ng/ml of OPI were tested with a total of 360 Drog-o-test Morphine/Heroin/Opiate kits The samples were tested two times in the same day, and in two different assays, each day for 20 days. This permits separate comparisons of between-day. between-assay and within-day results, which show «ood consistency

CUTOFF STUDIES
There were a total of 200 urine samples including 50 samples containing zero, 50 samples below the cutoff (225 ng/ml). 50 samples at the cutoff (300 ng/ml) and 50 samples above the cutoff (375 ng/ml) Both and a commercially available immunoassay test kit tested all 200 urine samples Complete agreement was observed at 99 43 % and the test cutoff established at 300 ng/ml of OPI

SPECIFICITY AND INTERFERENCE STUDIES
The following table lists compounds that are detected by the Drog-o-test Morphine/Heroin/Opiate. The results are expressed in terms of the concentration required to produce a positive result

Potentially interfering chemicals such as pain medication (Acetaminophen, 20 mg/dl), protein (2000 mg/dl), glucose (2000 mg/dl), hemoglobin (500 mg/ml) and pH 6.0, of 7.0 and 8.0 were supplemented lo normal urine specimens devoid of OPI. The test gave consistently negative results The base line urine with 300 ng/ml OPI scored consistently positive

REFERENCES

1. Urine Testing for Drugs of Abuse. National Institute for Drug Abuse (N1DA), Research
   Monograph 73, 1986.
2. Ambre. J J Anal Toxicol. 9:241-5. 1985

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