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ANALYTICAL PROCEDURE

Policy Guidelines

 The Laboratory performs a validated test to differentiate negative specimen from a


specimen that requires further testing for drugs and or metabolites
 The methods used-
o Qualitative method- this employs the use of a drug testing kit and is done
manually.
 The laboratory will submit all samples with positive results to any DOH accredited
confirmatory drug testing laboratory Together with the sample, the following
documents must be submitted:
o Accomplished Custody and Control Form
o Initial Laboratory report
o Request letter for confirmatory
 The laboratory may conduct a repeat screening test on the same specimen prior to the
confirmatory test.
 The release of the results will be dependent on the:
o Availability of Confirmatory Laboratory
o Distance of the Confirmatory laboratory to the screening laboratory.
 The laboratory will keep the specimen with negative results for a minimum of 5 days
upon receipt of results. In case the Donor does not retrieve the result, the laboratory
has the option to discard the specimen after 5 days.

Principle

This test is an immunoassay based on the principle of competitive binding. Drugs which may be
present in the urine specimen compete against their respective drug conjugate for binding sites on
their specific antibody

A drug-positive urine specimen will not generate a colored line in the specific test line region of the
strip because of drug competition, while a drug negative specimen will generate a line in the test
region.

Test Procedure

Allow the device and specimen to equilibrate to room temperature (10’c-30’c) prior to testing.

1. Remove a testing device from the foil pouch by tearing at he notch and place it on a level
surface.
2. Holding a sample dropper vertically, add exactly four drops of the urine specimen to the
sample well.
3. Read results in five minutes. Do not read results after more than 5 minutes.

Interpretation of Results

Positive (+)
A rose-pink band is visible in the control region. No color band appears in the appropriate test
region. It indicates a positive result for the corresponding drug of that specific test zone.

1. Cannabinoids and Methamphetamine positive : No color band appears in both the Test line 1
and Test line 2 regions.
2. Methamphetamine positive: No color band appears in (Test line 1) the appropriate test region
away from the control region.
3. Cannabinoids positive: No color band appears in (Test line 2) the appropriate test region
close to control region.

Negative (-)

A rose-pink band is visible in the control region and the appropriate test regions (both the Test line 1
and Test line 2). It indicates that the concentration of the corresponding drug of that specific test
zone is zero or below the detection limit of the test.

Invalid

If a color band is not visible in the control region or a color band is only visible in the test region, the
test in invalid.

1 2 C 1 2 C 1 2 C

Met and THC positive Met positive THC positive

1 2 C
Negative positive

1 2 C 1 2 C 1 2 C 1 2 C
Invalid Invalid Invalid Invalid

Specimen storage

Urine specimen may be stored at 2-8 degrees Celsius for up to 48 hours prior to assay. For prolonged
storage, specimens may be frozen and stored below – 20 degrees Celsius. Frozen specimens should
be thawed and mixed before testing.

Limitations

This test provides only preliminary analytical result. A more specific chemical method must be used
to obtain a confirmed result.

Technique errors as well as other interfering substances in the urine specimen may cause erroneous
results.

Adulterants, such as bleach and or alum, in urine specimen may produce erroneous results regardless
of the analytical method. If adulteration is suspected, the test should be repeated with another urine
specimen

A positive result indicates presence of the drug or its metabolites but does not indicate level of
intoxication.

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