How can I identify the lot number and expiration of the UScreen Cup?

The lot number and expiration date can be found on the outside of the foil package. Each cup is individually packaged. All drug test cups will all have the same lot number and expiration date in the box  (25 tests). The label on the outside of each box of 25 tests will display the lot number and expiration date.

Lot Number Found On Foil Package and Box Label

Expiration Date Found on Foil Package and Box Label

How can I identify the Item Code of the UScreen Cup?

The Item Code for the particular SKU (drug panel) of the UScreen Cup can be found on the outer pouch for the cup and the inner carton containing the cups.

Find the Uscreen item code / SKU on the foil package

Find the Uscreen  item code / SKU on the box label

What are the precautions for performing a test with the UScreen Cup?

The UScreen Cup is for external use only. Do not use if the pouch is punctured or not sealed. The test cannot be used more than once—discard after first use. Do not use beyond the expiration date shown on the pouch. Keep out of the reach of children.

Users should follow the appropriate federal, state, and local guidelines concerning the frequency of assaying external quality control materials. There is an internal procedural control line in the test device termed the ‘Control Region’. However, the use of external controls is strongly recommended as good laboratory testing practice to confirm the test procedure and to verify proper test performance. Positive and negative controls should give the expected results. When testing the positive and negative control, the same assay procedure should be adopted.

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How to interpret an INVALID result with the UScreen Cup?

If a colored band is not visible in the Control Region (C) or a colored band is only visible in the Test Region (T), the test is invalid. Another test should be opened and run to re-evaluate the specimen. If the test still provides an invalid result, please contact the distributor from whom you purchased the product. When calling, be sure to provide the lot number and the catalog number of the test shown on pouch.

Interpreting the Results: 

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How to interpret a PRELIMINARY POSITIVE result with the UScreen Cup?

A colored band must be visible in each control region (C) to indicate that the test is valid. If no color band appears in the appropriate Test Region (T), a preliminary positive result is indicated for the drug corresponding to that specific test zone. The test area must be white to be considered preliminarily positive. Additional testing is necessary to confirm the preliminary positive results. Positive results should be “confirmed” by an alternate method such as GC-MS or LC-MS/MS.

Interpreting the Results: 

Uscreen Cup CLIA Package Insert

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How to interpret a NEGATIVE result with the UScreen Cup?

A colored band must be visible in each control region (C) to indicate that the test is valid. If a colored band is visible in any of the Test Regions (T), it indicates that concentration of the drug in the corresponding test zone is absent or below the detection limit of the test. Certain lines may appear lighter or thinner than other lines. ANY COLORED LINE VISIBLE IN THE TEST REGION (T), SHOULD BE INTERPRETED AS A NEGATIVE RESULT. NO MATTER HOW DARK OR FAINT THE LINE, THE TEST SHOULD BE INTERPRETED AS A NEGATIVE RESULT.

Interpreting the Results: 

UScreen_Drug_Test_Cup_Package_Insert

Uscreen Cup CLIA Package Insert

What if I forget to read the drug test results before 10 minutes?

If you read the test results too early or after ten minutes, the test results may be not accurate.  In this case the test results should not be considered.

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Uscreen Cup CLIA Package Insert

How to read the UScreen Cup test results

Interpreting the Results: 

Negative Test Result

A colored band must be visible in each control region (C) to indicate that the test is valid. If a colored band is visible in any of the Test Regions (T), it indicates that concentration of the drug in the corresponding test zone is absent or below the detection limit of the test. Certain lines may appear lighter or thinner than other lines. ANY COLORED LINE VISIBLE IN THE TEST REGION (T), SHOULD BE INTERPRETED AS A NEGATIVE RESULT. NO MATTER HOW DARK OR FAINT THE LINE, THE TEST SHOULD BE INTERPRETED AS A NEGATIVE RESULT.

Invalid Test Result

If a colored band is not visible in the Control Region (C) or a colored band is only visible in the Test Region (T), the test is invalid. Another test should be opened and run to re-evaluate the specimen. If the test still provides an invalid result, please contact the distributor from whom you purchased the product. When calling, be sure to provide the lot number and the catalog number of the test shown on pouch.

Drug Test Cup Package Insert

UScreen Cup CLIA Package Insert

What is the cutoff level?

One of the key concepts within drug testing is the application of a cutoff level. This is the point which seperates a test result as being either positive or negative.

For drug tests, a cutoff is chosen that will optimise drug detection but minimise the number of false positive results. It is important to note that a negative sample doesn’t mean that it is drug free; it might contain a drug at a concentration that is lower than the defined cut-off.

If a drug test is reported as screen positive or presumptive positive, this merely shows a response, which is usually because a drug is present. It cannot show how much drug was taken or be correlated to any degree of impairment. As this is a screening tool, all presumptive positives require a confirmation test.

How much specimen is needed for the UScreen Cup?

Instruct the donor to fill the cup at least to the minimum fill mark (30mL). Immediately read the temperature to verify that the urine temperature is within the acceptable range 32-38ºC (90-100ºF).

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Uscreen Cup CLIA Package Insert