eScreen Quality Watch

Indications for use

The Alere eScreen® Drugs of Abuse Screening system is intended for use by professionals in prescription work place settings for the rapid, qualitative detection of target drugs and/or metabolites including cocaine, cannabinoids, methamphetamine, opiates, and phencyclidine in urine. The eScreen system is a ‘screen only’ device. All inconclusive samples are sent to Substance Abuse and Mental Health Services Administration (SAMHSA) certified laboratories for further testing. The eScreen system is intended for use by professionals for the automated screening of drugs of abuse in human urine and is not intended for over the counter sales to lay persons. 

Validation and cutoff levels

The eScreen Drugs of Abuse Screening System includes the eCup® and the eReader®. The eCup is the combination of a urine collection device and lid. The lid incorporates the use of a pipetting device and two in vitro diagnostic test strips. The eReader is designed exclusively to actuate the pipetting device and electronically “read” the test strips located on top of the eCup.

The two test strips, located inside the eCup lid, utilize qualitative competitive inhibition immunoassay strip technology for the qualitative determination of the presence of the following classes of drugs and their metabolites at the following cutoff concentrations:

  • Cocaine - 300 ng/mL
  • Phencyclidine - 25 ng/mL
  • Cannabinoids - 50 ng/mL
  • Methamphetamine - 1000 ng/mL
  • Morphine - 2000 ng/mL

HIPAA

eScreen has implemented a Privacy Policy to ensure proper access, uses, and disclosures of Individually Identifiable Health Information (IIHI) and/or Protected Health Information (PHI), and serves as an extension of the Proprietary Information Policy for eScreen, Inc.

The guidelines set forth in this policy represent the covenants and restrictions imposed through our role as a Business Associate to a Covered Entity as defined in the Health Insurance Portability and Accountability Act of 1996 (HIPAA). eScreen is not considered to be a diagnostic entity that is generating, storing or transmitting medical healthcare-related data. We recognize our responsibilities to ensure that this information is secure from unauthorized access, and have implemented a security model that incorporates the highest level of authentication, encryption, & transmission standards available.

Random and blind eCup testing

It is eScreen’s policy and procedure to complete a monthly series of eCup QC tests at 20 randomly selected eScreen point-of-care provider sites. The clinic sites will receive a blind sample of urine and instructions on how to run the test. Clinics use the eScreen QC Test Account on the eScreen123® software. Once the test is complete, eScreen tracks the specimen to ensure that the test results are accurate and all confirmatory results from the lab are correct. This allows eScreen the opportunity to ensure that field equipment is performing normally.

CLIA regulations

Employment related drug screening is not currently subject to Clinical Laboratory Improvement Amendments (CLIA) Federal Regulations, provided the screening is unrelated to drug treatment. Alere eScreen retains information indicating CLIA is not applicable to our employment-related drug testing device. For more information, please visit the FDA's Clinical Laboratory Improvement Amendments webpage. Please be sure to research your appropriate state and local regulations, which may contain important information regarding employment drug screening.

Clinical studies

The eScreen device (eScreen eCup and eScreen eReader) is intended to provide preliminary analytical test results for Cannabinoids, Cocaine, Opiates (Morphine), PCP (Phencyclidine), and Amphetamine (Methamphetamine) at the SAMHSA (NIDA) published cutoff concentrations. The clinical human urine samples were aliquots obtained from SAMHSA certified laboratories that had been previously screened by Emit and confirmed by GC-MS (Gas Chromatography/Mass Spectroscopy) in accordance with guidelines established for SAMHSA certified laboratories.

The comparison between the results obtained with the eScreen device using clinical samples previously screened by Emit and confirmed by GC-MS demonstrated that the eScreen device provides an accurate preliminary test result (97% agreement of eScreen system to GC-MS).

Non-clinical studies

Analysis of the analytical sensitivity, stability, precision and specificity (interference with defined cross-reactive substances) were conducted using human urine specimens spiked with known concentrations of the drugs/metabolites of interest. These human urine samples were prepared from pools of certified negative urine. Certified negative urine pools were screened by immunoassay (Emit, Syva (Dade Behring) and assayed by GC-MS).

Positive urine materials were prepared from certified negative urine, spiked with known concentrations of pure drug and drug metabolites. Positive urine stock solutions were verified by analysis using GC-MS. In each of these non-clinical tests, the eScreen system was shown to reproducibly detect the presence of the indicated drugs of abuse at the cutoff concentrations specified on the previous page.

Test and demo eCups

In order for point-of-care providers to train and demonstrate the eCup and the eReader functions, eScreen produces Test/Demo eCups for use with the eScreen123 software. The demo eCups are prepared as negative and “send to lab” or presumptive positive. This allows the clinic staff to train and practice on the eScreen123 system between “live” collections. It saves time and money for the clinics, as they do not waste a “real” eCup. This process also serves as a validation that the eReader is correctly and accurately screening and providing the appropriate test.

eReader calibration

eReaders do not require field calibration, instruments are tested and certified during assembly. eReaders manufactured since early 2008 are shipped with “No Calibration Required” stickers affixed to the bottom of the reader. If clinics require a “No Calibration Required” sticker for their earlier model readers to meet internal equipment inspection and calibration requirements, eScreen can provide them upon request.

eScreen manufacturing

eScreen’s Phoenix, Arizona Operations manufactures, warehouses and ships eScreen’s proprietary eCup and eReader products. All Phoenix Operations medical device processes comply with applicable Code of Federal Regulations (CFR) for medical devices; including Current Good Manufacturing Practices (CGMP).