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Selection Management offers the the first check family of tests for Drugs of abuse including cocaine, marijuana, methamphetamines, morphine / opiates, amphetamines, phencyclidine and barbiturates. First Check® Panel 4 simultaneously checks for marijuana (THC), morphine/opiates, cocaine, and amphetamines. First Check™ THC is a specific test for marijuana, and First Check™ COC is a specific test for cocaine. Click here for more information on test procedures.

Simultaneously detects the presence of four drugs of abuse within five minutes.

First Check Panel 4 is a true one-step, 5 minute immunometric assay which simultaneously detects the presence of marijuana (THC), morphine/opiates, cocaine, and amphetamines using just 3 drops of urine as a test specimen.

First Check Drugs of Abuse Tests are designed to detect the presence of each drugs of abuse at the cut-off levels recommended by the National Institute of Drug Abuse (NIDA).

Catalog No. 6100 - 25 Tests/Box

INTENDED USE
The First Check™ THC test is a simple, one-step, immunochromatographic assay for the rapid, qualitative detection of THC in urine. This is intended for use in the qualitative detection of cannabinoids in human urine with a cut-off at 50ng/mL.

The First Check™ THC 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 con firmatory and professional judgment should be applied to any drug of abuse test result , particularly when preliminary positive results are used(1).

SUMMARY AND PRINCIPLE OR PROCEDURE
HTC (9-tetrahydrocannabino) is the primary active ingredient in cannabinoids (marijuana). When ingested or smoked, it produces euphoric effects. Users have impairment of short term memory and THC use slows learning. Also, it may cause transient episod es of confusion, anxiety, or even frank toxic delirium. Long term, relatively heavy use may be associated with behavioral disorders. The peak effect of smoking THC occurs in 20-30 minutes and the duration is 90-120 minutes after one cigarette. Elevated le vels of urinary metabolites are found within hours of exposure and remain detectable for 3-10 days after smoking. The main metabolite excreted in the urine is 11-nor-9-tetrahydrocannabinol-9-carbonxylic acid.

The First Check™ THC 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 fo r binding to the antibodies between drug conjugates and drugs which may be present in the urine sample. In the test procedure, a sample of urine is placed in the sample well of device, and the sample is allowed to migrate upward. If drug is present in the urine sample, it competes with drug conjugate, which is immobilized on the membrane, for the limited antibodies present in the form of dye-antibody conjugate. When sufficient amount of drug is present, the drug will saturate the antibodies, and the dye-a ntibody conjugate cannot bind to the drug conjugate on the membrane. Therefore, a drug-positive urine sample will not generate a line in the test window, indicating a negative result from an absence of competition with free drug.

MATERIALS PROVIDED
The First Check THC test kit contains all the reagents necessary to perform the assay.

• First Check THC device The test device contains a membrane coated with drug conjugate and a pad containing anti-THC antibody-dye conjugate in a protein matrix.
• Disposable sample dispenser
• Instructions for use

PRECAUTIONS

• For professional in vitro diagnostic use only.
• Avoid cross contamination of urine samples by using a new urine specimen container and dropper for each urine sample.
• Urine specimens are potentially infectious. Proper handling and disposal methods should be established, according to good laboratory practices.
• The First Check™ THC device should remain in its original sealed pouch until ready for use.
• Do not use the test kit after the expiration date.

STORAGE AND STABILITY
The First Check™ THC test kits should be stored at 4-30 C (40-86 F) in the original sealed pouch.

SPECIMEN COLLECTION AND PREPARATION
Approximately 150 uL of urine sample is required for each test. Fresh urine specimens do not require any special handling or pretreatment. Specimens should be collected in a clean glass or plastic container. If testing will not be performed immediatel y, specimens should be refrigerated (2-8 C) or frozen. Specimens should be brought to room temperature before testing. Specimens should be clarified by centrifuging or allowing to settle before testing.

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 Test window.

TEST PROTOCOL

• For each test, open one First Check™ THC pouch and label the device with the patient ID.
• Holding the dropper vertically, dispense 3 drops (150 uL) of the urine sample into the Sample well.
• Read the results after 3 minutes, but within 10 minutes.

INTERPRETATION OF RESULTS

Negative Two Lines
The appearance of two reddish-purple lines in the Test window and the other in the Control window indicates a negative test result; ie., no THC above the cut-off level has been detected. The color of the Test line may be weaker or stronger than that o f the Control line.

Positive One Line
The appearance of only one reddish-purple line in the Control window and no distinct line in the Test window indicates the result is positive; i.e., the specimen contains THC at a concentration above the cut-off level.

Invalid
A distinct colored line should always appear in the Control window. The test is invalid if no line forms in the Control window.

Note: A very faint line in the Test window, visible in 10 minutes, indicates that the amount of THC in the sample is near or below the cut-off level of the test. These urine specimens must be retested, or confirmed with a more specific alternative met hod such as gas chromatography/mass spectrometry, before positive determinations are made.

Limitations

• The test is designed for use with unadulterated urine only.
• There is a possibility that factors such as technical or procedural errors, as well as other substances in the urine sample may interfere with the test and cause erroneous results.
• Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the method of analysis. If adulteration is suspected, the test should be repeated with a new sample.
• This test detects only the presence of THC and/or its metabolites in urine. A positive test result does not provide any indication of the level of intoxication or urinary concentration.
• The test result read after 10 minutes may not be consistent with the original reading obtained within the 10 minute reading period. The test must be read within 10 minutes of sample application.
• Prolonged passive smoking of THC may produces a positive result.

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 Worldwide Medicals Technical Services. Before using a new kit with patient specimens, positive and negative controls should be tested to confirm the test procedure, and to verify the tests produce the expected Q.C. results.

The Control line can be considered an internal control. A distinct reddish-purple Control line should always appear if the test procedure is performed properly and the test reagents are working. If the problem persists, contact Worldwide Medical for t echnical assistance.

EXPECTED VALUES
The First Check™ THC is 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 results indicates the sample contains c annabinoids above the cut-off concentration.

PERFORMANCE CHARACTERISTICS
The First Check™ THC test has been shown to detect an average of 50 ng/ml or more of THC metabolites in urine. The accuracy of First Check™ THC was evaluated in comparison to a commercially agreement was observed in 99% of the samples.

In a separate study, first Check™ THC was evaluated against specimens confirmed as positive by GC/MS. Of 88 samples confirmed as positive, 87 samples were positive when tested with First Check™ for 99% agreement.

REPRODUCIBILITY
The reproducibility of the test results of the First Check™ THC was examined at three different sites using a total of 15 blind controls, consisting of 5 negative samples, 5 moderately positive samples, and 5 strongly positive samples (i.e., a co ncentration 3 times the cut-off level). The results obtained at these three sites with these controls demonstrated 100% agreement with each other.

SPECIFICITY
The following table lists compounds that are detected by First Check™ THC test. The results are expressed in terms of the concentration required to produce a positive result.

REFERENCES

• R.C. Baselt, Disposition of Toxic Drugs and Chemical in Man, 2nd Ed.,
  Biomedical Publ., Davis, CA., 1982, p.488.
• Urine testing for Drugs of Abuse, National Institute for Drug Abuse
  (NIDA), Research Monograph 73, 1986.

Catalog No. 6000 - 25 Tests/Box

INTENDED USE
The First Check™ COC, a simple one-step immunoassay is intended for use in the qualitative detection of cocaine metabolite in human urine with a cut-off at 300 ng/mL.

The First Check™ COC 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. Clinical consideration and professional judgment should be applied to any drug of abuse test result , particularly when preliminary positive results are used.

SUMMARY AND PRINCIPLE OR PROCEDURE
Cocaine derived from the leaves of coca plant is a potent central nervous systems (CNS) stimulant and local anesthetic. Cocaine induces euphoria, confidence and a sense of increased energy in the user; these psychological effects are accompanied by increased heart rate, dilation of the pupils, fever, tremors, and sweating.

Cocaine is used by smoking, intravenous, intravenous or oral administration and excreted in the urine primarily as benzolecgonine in a short time(1). Benzoylecgonine has a longer biological half-life (5-8 hours) than cocaine (0.5-1.5 hours) and can generally be detected for 24-60 hours after cocaine use or exposure(2).

The First Check™ COC test uses solid-phase immunoassay technology for the qualitative detection of cocaine metabolite, benzoyelecgonnie, in human urine. This test is based on the competition for the limited antibodies between immobilized drug conjugate on the membrane and drug or drug metabolite which may be present in the urine being tested. In the test procedure, a sample of urine is placed in the sample well and is allowed to migrate upward. When the drug is present in the urine sample, it competes with drug conjugates which are immobilized on the membrane for the limited amount of antibodies present in the dye-antibody conjugate. When sufficient amount of drug or drug metabolite above the cut-off level is present, it will occupy all the antibody binding sites, and thus inhibit the binding of dye-antibodies to the drug conjugate preventing the formation of a line on the membrane. In addition to the Test line that may appear in the Test window, a Control line is added in the Control window to confirm the viability of the test. This Control line should always be seen if the test is conducted properly. Therefore, the presence of two lines, one in the Test window and the other in the Control window, indicates a negative result; while the absence of a line in the Test window indicates a positive results.

The First Check™ COC provides only a qualitative test results. To obtain a confirmed analytical results, more specific alternative methods such as gas chromatography/mass spectrometer (GC/MS) should be used(3).

MATERIALS PROVIDED

• The First Check COC test kit contains all the reagents necessary to perform 25 tests.
• First Check COC device. The test device contains a membrane coated with drug conjugate and a pad with antibenzoylecgonine antibody-dye conjugate; 25 test devices
• Disposable specimen dispenser; 25 each
• Instructions for use

PRECAUTIONS

• For professional in vitro diagnostic use only.
• Avoid cross contamination of urine samples by using a new urine specimen container and dropper for each urine sample.
• Urine specimens are potentially infectious. Proper handling and disposal methods should be established, according to good laboratory practices.
• The First Check™ COC device should remain in its original sealed pouch until ready for use.
• Do not use the test kit after the expiration date.

STORAGE AND STABILITY
The First Check™ COC test kits should be stored at 4-30 C (40-86 F) in its original sealed pouch.

SPECIMEN COLLECTION AND PREPARATION
Approximately 150 uL of urine sample is required for each test. Fresh urine specimens do not require any special handling or pretreatment. If testing will not be performed immediately, specimens should be refrigerated (2-8 C) or frozen. Specimens should be brought to room temperature before testing.

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 Test window.

TEST PROTOCOL

1. For each test, open one First Check™ COC pouch.
2. Holding the dropper vertically, dispense 3 drops (150 uL) of the urine sample into the Sample well and label the First Check™ device with the patient ID.
3. Read the results after 3 minutes, but within 10 minutes.

  INTERPRETATION OF RESULTS

• Negative Two Lines: The appearance of two reddish-purple lines in the Test window and the other in the Control window indicates a negative test result; ie., no cocaine above the cut-off level has been detected. The colored lines will appear within 1 to 3 minutes. The color of the Test lines may be weaker or stronger than that of the Control line.
• Positive One Line: The appearance of only one reddish-purple line in the Control window and no distinct line in the Test window indicates the result is positive (i.e., the specimen contains more than 300 ng/ml of cocaine and its metabolites).
• Invalid: A distinct colored line should always appear in the Control window. The test is invalid if no line forms in the Control window.

Note: A very faint line in the Test window, visible in 10 minutes, indicates that the amount of cocaine in the sample is near or below the cut-off level of the test. These urine specimens must be retested, or confirmed with a more specific alternative method such as gas chromatography/mass spectrometry, before positive determinations are made.

 Limitations

• The test is designed for use with unadulterated urine only.
• There is a possibility that factors such as technical or procedural errors, as well as other substances in the urine sample may interfere with the test and cause erroneous results.
• Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the method of analysis. If adulteration is suspected, the test should be repeated with a new sample.
• This test detects only the presence of cocaine and/or its metabolites in human urine. A positive test result does not provide any indication of the level of intoxication or urinary concentration.
• The test result read after 10 minutes may not be consistent with the original reading obtained within the 10 minute reading period.
• The test must be read within 10 minutes of sample application.

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 Worldwide Medical’s Technical Services. Before using a new kit with patient specimens, positive and negative controls should be tested to confirm the test procedure, and to verify the tests produce the expected Q.C. results.

 The Control line can be considered an internal control. A distinct reddish-purple Control line should always appear if the test procedure is performed properly and the test reagents are working. If the Control line does not appear, the test is invalid and a new test should be performed. If the problem persists, contact Worldwide Medical for technical assistance.

EXPECTED VALUES
The First Check™ COC is 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 results indicates the sample contains cannabinoids above the cut-off concentration.

PERFORMANCE CHARACTERISTICS
The National Institute on Drug Abuse has suggested that the screening cut-off for positive samples be 300 ng/ml for cocaine. The First Check™ COC test has been shown to detect an average of 300 ng/ml or more for cocaine or its metabolites in urine. The accuracy of First Check™ COC was evaluated in comparison to a commercially available immunoassay at a cut-off of 300 ng/ml. A total of 1021 samples were tested by both procedures with 97% agreement.

In a separate study, first Check™ COC was evaluated against specimens confirmed as positive by GC/MS. Of 78 samples confirmed as positive, 77 samples were positive when tested with First Check™ for 99% agreement.

PRECISION
The precision of the First Check™ COC assay was determined by conducting the test with serially diluted standard drug solution. About 95% of the samples containing drug concentrations 20% over the cut-off level consistently showed positive results.

REPRODUCIBILITY
The reproducibility of the test results of the First Check™ COC was examined at three different sites using a total of 15 blind controls, consisting of 5 negative samples, 5 moderately positive samples, and 5 strongly positive samples (i.e., a concentration 3 times the cut-off level). The results obtained at these three sites with these controls demonstrated 100% agreement with each other.

SPECIFICITY
The First Check™ COC test detects the cocaine metabolite, benzoylecgonine. The following table lists compounds that cross react in this test. The results are expressed as the concentration required to produce a positive result.

REFERENCES

• Stewart, D.J., Inoba, T., Ducassen, M., and Kalow, W. Clin. Pharmacol. Ther. 25; 264-8 (1979).
• Ambre, J. J. Anal. Toxicol. 9; 241-5 (1985).
• Urine Testing for Drugs of Abuse, National Institute for Drug Abuse (NIDA), Research Monograph 73, 1986.

Before you begin:
Read all the instructions before performing the test. First, make sure you are familiar with the test kit contents shown, below. Store at 36-86 F (2-30 C) in the sealed pouch, away from direct sunlight. Do not use after the expiration date stamped on the package.

Instructions:

1. Open the sealed pouch, remove the First Check card and set the card on a flat surface with test and control windows facing up.
2. Collect urine sample in a clean plastic or glass container. 
   With sample dispenser over sample, press bulb between thumb and index finger, insert dispenser opening into sample and release on bulb. You should see sample fill half of dispenser tube. Do not discard the unused urine until after the test has been completed and the result interpreted.
3. With sample dispenser in vertical position over sample well of test card, gently squeeze dispenser bulb, to allow 3 fully-formed drops of urine, one at a time, to free-fall into sample well. Do not "touch-off" drops. If flow of sample is not seen in the test window, add 1 more drop of urine to sample well.
   Allow the test card to remain undisturbed until result is read. Read the results after time indicated.

Results:
	2 Lines - Negative Two horizontal lines, one in each of the Control (upper) windows and Test (lower) window, means there is no drug present in the urine sample. The line in the Test window may be lighter or darker than the line in the Control window.  Wait until time indicated to read results.  NO DRUG TAKEN
	1 Line - Positive One line in the Control window and one line in the Test window means the sample contains the drug.  Wait until time indicated to read results.   DRUG TAKEN
	Invalid Test A distinct colored line should always appear in the Control (upper) window. If no line appears in the Control window.  Wait until time indicated to read results.  DO NOT INTERPRET RESULT
Limitations:
The First Check One-Step Drug Test is not reusable. The test instructions must be followed precisely.