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.

a. Description of the Methods Used

Multi-Drug One Step Screen Test Panel

Intended use
1. A rapid one-step screen test for the simultaneous and qualitative
detection of multiple drugs and metabolites in human urine.
Method used
2. The Multi-Drug One Step Screen Test Panel (Urine) is lateral flow
chromatographic immune assay for qualitative detection of the drugs
without the need of instruments
XI. Work instruction for the following drugs:
3. Amphetamines
4. THC
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
During testing, a urine specimen migrates upward by capillary action. A drug , If present in
the urine specimen below its cut off concentrations will not saturate the binding sites of its
specific antibody coated on the particles. The immobilized drug conjugate will then capture
the antibody coated particles and a visible colored line will show up in the test line region of
the specific drug strip
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.

Sample collection and preparation

The urine specimen must be collected in a clean dry container. Urine collected at any time of
the day may be used. Urine specimens exhibiting visible precipitates should be centrifuged,
filtered, or allowed to settle to obtain a clear supernatant for testing.

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.