ACE Rapid Test Cassette,cut-off 5,000ng/mL, Acetamin/ophen Test,
Drug Abuse Test Kit
| Principle | Chromatographic Immunoassay |
| Format | Dipstick, Cassette, Panel, Cup |
| Specimen | Urine, Powder |
| Certificate | CE |
| Reading Time | 5 minutes |
| Pack | 25T/40T/50T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
| Sensitivity | 93.50% |
| Specificity | 98.60% |
| Accuracy | 97.00% |
| Cut-Off | 5000 ng/mL* |
A rapid test for the qualitative detection of Acet/aminophen in
human urine. For medical and other professional in vitro diagnostic use only.
INTENDED USE
The ACE Rapid Test Cassette (Urine) is a rapid chromatographic
immunoassay for the detection of Aceta/minophen in human urine at a cut-off
concentration of 5,000ng/mL. This assay provides only a qualitative, preliminary analytical test
result. A more specific alternate chemical method must be used in order to obtain a
confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) or Liquid
Chromatography/mass spectrometry (LC/MS) are the preferred confirmatory methods. Clinical
consideration and professional judgment should be applied to any drug of abuse test result,
particularly when preliminar positive results are used.
SUMMARY
Acetaminoph/en is one of the most commonly used drugs, yet it is
also an important cause of serious liver injury. Acetamin/ophen is the generic name of a drug
found in many common brand name over-the-counter (OTC) products, such as Tylenol, and
Prescription (Rx) products, such as Vicodin and Percocet. Acetam/inophen is an
important drug, and its effectiveness in relieving pain and fever is widely known. Unlike
other commonly used drugs to reduce pain and fever (e.g., nonsteroidal antinflammatory drugs
(NSAIDs), such as aspirin, ibuprofen, and naproxen), at recommended doses acetami/nophen does
not cause adverse effects, such as stomach discomfort and bleeding, and
acetamin/ophen is considered safe when used according to the directions on its OTC or Rx labeling.
However, taking more than the recommended amount can cause liver damage, ranging from
abnormalities in liver function blood tests, to acute liver failure, and even death. Many
cases of overdose are caused by patients inadvertently taking more than the recommended
dose (i.e., 4 grams a day) of a particular product, or by taking more than one product
containing acetamin/ophen (e.g., an OTC product and an Rx drug containing acetami/nophen).
The mechanism of liver injury is not related to acetam/inophen itself, but to the
production of a toxic metabolite. The toxic metabolite binds with liver proteins, which cause cellular
injury. The ability of the liver to remove this metabolite before it binds to liver protein influences
the extent of liver injury.
The ACE Rapid Test Cassette (Urine) is a rapid urine screening test
that can be performed without the use of an instrument. The test utilizes a monoclonal
antibody to selectively detect elevated levels of Acetam/inophen in urine. The ACE Rapid Test
Cassette (Urine) yields a positive result when Aceta/minophen in urine exceeds 5,000ng/mL.
PRINCIPLE
The ACE Rapid Test Cassette (Urine) is an immunoassay based on the
principle of competitive binding. Drugs which may be present in the urine
specimen compete against the drug conjugate for binding sites on the antibody.
During testing, a urine specimen migrates upward by capillary
action. Acetamin/ophen, if present in the urine specimen below 5,000ng/mL, will not saturate
the binding sites of antibody-coated particles in the test. The antibody-coated
particles will then be captured by immobilized Acetami/nophen conjugate and a visible colored line
will show up in the test line region. The colored line will not form in the test line region if
the Acetam/inophen level exceeds 5,000ng/mL because it will saturate all the binding sites of
anti-Aceta/minophen antibodies.
A drug-positive urine specimen will not generate a colored line in
the test line region because of drug competition, while a drug-negative urine specimen or a
specimen containing a drug concentration lower than the cut-off will generate a line in the
test line region. To serve as a procedural control, a colored line will always appear in the
control line region, indicating that proper volume of specimen has been added and membrane wicking has
occurred.
REAGENTS
The test contains mouse monoclonal anti-Aceta/minophen
antibody-coupled particles and Acetamin/ophen-protein conjugate. A goat antibody is employed in
the control line system.
PRECAUTIONS
• For medical and other professional in vitro diagnostic use only.
Do not use after the expiration date.
• The test should remain in the sealed pouch until use.
• All specimens should be considered potentially hazardous and
handled in the same manner as an infectious agent.
• The used test should be discarded according to local regulations.
STORAGE AND STABILITY
Store as packaged in the sealed pouch either at room temperature or
refrigerated (2-30°C).
The test is stable through the expiration date printed on the
sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use
beyond the expiration date
DIRECTIONS FOR USE
Allow the test, urine specimen, and/or controls to reach room
temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove
the test cassette from the sealed pouch and use it within one hour.
2. Place the test cassette on a clean and level surface. Hold the
dropper vertically and transfer 3 full drops of urine (approx. 120 µL) to the specimen
well (S) of the test cassette, and then start the timer. Avoid trapping air bubbles in
the specimen well (S). See the illustration below.
3. Wait for the colored line(s) to appear. Read results at 5
minutes. Do not interpret the result after 10 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
NEGATIVE:* Two distinct colored lines appear. One colored line
should be in the control line region (C), and another apparent colored line should be in the
test line region (T). This negative result indicates that the Aceta/minophen concentration is
below the detectable level (5,000ng/mL).
*NOTE: The shade of color in the test line region (T) will vary,
but it should be considered negative whenever there is even a faint colored line.
POSITIVE: One colored line appears in the control region (C). No
line appears in the test line region (T). This positive result indicates that the
Acet/aminophen concentration exceeds the detectable level (5,000ng/mL).
INVALID: Control line (C) fails to appear. Insufficient specimen
volume or incorrect procedural techniques are the most likely reasons for control line
failure. Review the procedure and repeat the test using a new test. If the problem
persists, discontinue using the lot immediately and contact your local distributor.
QUALITY CONTROL
A procedural control is included in the test. A colored line
appearing in the control region (C) is considered an internal procedural control. It confirms sufficient
specimen volume, adequate membrane wicking and correct procedural technique.
Control standards are not supplied with this kit; however it is
recommended that positive and negative controls be tested as good laboratory practice to confirm
the test procedure and to verify proper test performance
order information
| Cat. No. | Product | Specimen | Pack |
| DAC-102 | Acetami/nophen (ACE) Rapid Test Cassette | Urine | 40T |
| DAC-114 | Acetami/nophen (ACE) Rapid Test Panel | Urine | 40 T |
| DAC-101 | Acetamin/ophen (ACE) Rapid Test Dipstick | Urine | 50 T |
| DAC-X14 | Acetami/nophen (ACE) Rapid Test Panel | Powder | 25 T |
