Screening vs. Confirmatory Tests

There are two main categories of urine drug testing – screening (aka presumptive) followed by confirmation (CMS, 2016). Screening tests are initial, qualitative drug tests conducted to identify classes of drugs present in the urine and typically are done using immunoassay. They rely on a set threshold above which a positive result is produced and therefore do not detect lower concentrations of a drug. Confirmatory tests are used for further analysis of a sample – to confirm a positive or sometimes, negative, result and typically are done using gas chromatography/mass spectometry (GC/MS) or high performance liquid chromatography (HPLC). Confirmatory testing can identify a specific drug. If the goal is to detect a synthetic or semisynthetic opioid, this testing should be used as immunoassays do not typically detect these opioids.

Note that requirements for testing vary with the health insurance, with respect to reimbursement for UDT. For example, requirements have been shifting for Medicare and will likely continue to shift (CMS, 2016). For example, insurance may vary as to which codes they will reimburse; some may not reimburse multiple individual substances. Therefore, we recommend that providers consult with the insurance company in question before ordering drug tests.

Below is a comparison of the general characteristics of these two types of testing:

Screening (Point of care testing is usually only screening) Confirmatory
Analysis Technique Immunoassay Gas Chromatography-Mass Spectrometry (GC-MS) or High Performance Liquid Chromatography (HPLC)
Sensitivity (power to detect a class of drugs)
Low or none when testing for semi-synthetic or synthetic opioids High

Specificity (power to detect an individual drug)

Varies based on assay used - can result in false positives and false negatives High
Use Qualitative analysis; detects classes of drugs (Heit and Gourley, 2004)

Quantitative analysis; identifies a specific drug

Cost Inexpensive  (FDA five-drug testing kit ~ $1) More expensive, may not be paid for by insurance
Turnaround
On-site - rapid Slow
Other Intended for use in drug-free population; may not be useful in pain medicine context Legally defensible results

(Compton, 2007; Heit and Gourlay, 2004; Reisfeld, et al, 2007)

Due to the possibility of false positives and the qualitative nature of screening tests, confirmatory testing is recommended to affirm positive or unexpected results and to identify the presence of a specific drug (Compton, 2007; Reisfield, et al, 2007).

Point of Care UDT. Point of care UDT offers the advantage of quick results with all the limitations of screening tests described above. Providers may want to conduct screening tests at the point of care by obtaining a CLIA waiver.

Note that definitive testing identifies the specific drug and quantity of drug in the patient.

View ReferencesHide References
CMS. Calendar Year (CY) 2016 Clinical Laboratory Fee Schedule (CLFS) Preliminary Determinations. . 2016. Available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/CLFS-CY2016-Preliminary-Payment-Determinations.pdf Accessed on: 2016-01-12.
Compton P. The role of urine toxicology in chronic opioid analgesic therapy. Pain Manag Nurs. 2007; 8(4): 166-172. Available at: http://www.ncbi.nlm.nih.gov/pubmed/18036504 Accessed on: 2013-09-12.
Heit HA, Gourlay DL. Urine drug testing in pain medicine. J Pain Symptom Manage. 2004; 27(3): 260-267. Available at: http://www.ncbi.nlm.nih.gov/pubmed/15010104 Accessed on: 2013-09-12.
Reisfield GM, Salazar E, Bertholf RL. Review: rational use and interpretation of urine drug testing in chronic opioid therapy. Ann Clin Lab Sci. 2007; 37(4): 301-314. Available at: http://www.ncbi.nlm.nih.gov/pubmed/18000286 Accessed on: 2013-09-16.