What is the difference between an enzyme immunoassay (EIA) test and analysis by Mass Spectrometry (MS)?
Aspenti Health uses EIA technology as the initial screening tests. These tests are reagent-based systems that rely upon antibodies to detect drug compounds. Most EIA testing identifies classes of drug compounds present in a sample and can identify nonspecific drugs (those that cross-react and screen as positive) as well. All positive drugs screens must be considered presumptive until confirmed by LC-MS/MS.
Analysis by LC-MS/MS is used as an alternative methodology to quantitate individual drug compounds, whether prescribed or not. These methods identify specific drug compounds at a molecular level by measuring the mass-to-charge ratio of ions and quantitating the compounds of interest. Mass spectrometry is considered the “gold standard” by experts in many fields for identification of widely varying compounds, including drugs. Results produced by MS analysis are considered definitive testing. Confirmation testing supports the results previously reported on the sample by EIA screening tests.
When will the screening test be completed?
Screening results, also known as preliminary results, are available within 24 hours from the time the patient specimen arrives in the laboratory, and are typically reported the same day as arrival.
When will results be available for quantitative analysis tests performed by Mass Spectrometry?
These results are generally available 2 to 3 business days after having received the patient specimen in the lab.
How and when are my results reported?
Preliminary and final results will be delivered by the method that works best for your practice. These HIPAA-compliant methods include our password-protected secure web portal, print, fax, mail, and HL7 electronic transmission.
Why are positive results for screening (EIA) tests followed by confirmatory Mass Spectrometry (MS) testing for some?
The benefit of confirmation testing by (MS) is the ability to generate definitive test results that complement the presumptive positive screens and result in better directed care for patients. Confirmatory testing takes the reported EIA results and identifies individual drug contributors. For example, a positive opiate screen (EIA) recognizes that the patient has ingested an opiate like compound. The confirmation will expand on the EIA testing to show that a positive codeine and morphine results were the cause of the initial positive screen test.
What is meant by “cutoff” level?
A cutoff level is the decision point at which a result is determined to be negative or positive. For example, if a screen test has a cutoff of 500 ng/mL, a screen result of 300 ng/mL would be reported as negative. A screening result of 505 ng/mL would be reported as positive on the final report. A “positive” EIA screening test notation would be considered presumptive and for most assays would include a semi-quantitative value.
Regarding confirmation by MS, the cutoff levels are typically much lower than the screening. Therefore, the threshold for determining a positive result is reduced and is more definitive.
What is the stability of a urine specimen and the optimal conditions to store specimens?
Urine specimens for testing are stable at room temperature for up to seven days and refrigerated for up to 30 days. Aspenti Health retains all specimens for 14 days from receipt before discarding unless arrangements are made otherwise.
A specimen collected Monday through Thursday should be sent to Aspenti’s laboratory on the same day it was provided whenever possible. Refrigeration is recommended, for samples that are not sent out the same day of collection and/or collected on a Friday, Saturday or Sunday.
Does a urine sample need to be shipped as a biohazard?
No, urine samples do not contain biohazard material and following Department of Transportation (DOT) and International Air Transport Association (IATA) regulations for infectious substances in transport, urine from routine collections is exempt from biohazard labeling. For handling, standard precautions such as gloves or other personal protective equipment is advised.
If a patient’s initial EIA screen is positive, should I wait for the confirmatory testing by MS before taking action?
Yes, but not always. It is important that no actions be taken based on a positive EIA screen test results that have not been confirmed by LC/MS/MS. Screening immunoassay technology inherently includes the possibility of cross-reactions and drug interferences for some assays. There are some screens that are not prone to cross reactivity, therefore a screen may suffice for treatment. Our Certifying Scientists are available to answer questions and provide more information about cross-reactivities.
Why was there a positive result for a drug immunoassay screen but a negative result when the confirmation by MS testing was performed?
Immunoassay drug screening is the most utilized type of testing performed by most laboratories. Inherent to most screening technologies used for testing, there are the possibilities of “cross-reactive” positives due to drug or drug-like substances that cause the screens to be positive. The reagent manufacturers we utilize for screening have investigated possible cross reactant drugs and have provided a list of compounds that can cause a positive screen. Due to the cross reactive positive occurrences that can occur for any drug screen, the reagent manufacturers recommend that any positive screen be tested by an alternative method, such as LC-MS/MS confirmations.
My patient is prescribed one benzodiazepine drug yet tested positive for several. Does this mean my patient is not taking the medication correctly?
Many of the drugs classified as benzodiazepines when tested can show up as common metabolites of other benzodiazepines. For example, oxazepam can be a prescribed medication, but it is also a metabolite of diazepam, chlordiazepoxide and clorazepate. Therefore, it is consistent for a patient taking diazepam to then test positive for oxazepam as well as nordiazepam and temazepam. These are all metabolites of the parent drug diazepam. The presence of these metabolites can confirm the use of diazepam, but cannot rule out use from other benzodiazepines that share the metabolites.
What do the terms “parent” and “metabolite” mean?
The two terms indicate how a drug will be detected in urine testing. Most drugs tested in urine will exist in their original formulation and breakdown/metabolite. For example, the parent drug buprenorphine is detected by screening and confirmation. Norbuprenorphine, which is the byproduct of buprenorphine, is the metabolite of the parent drug. When a patient is taking their buprenorphine as prescribed, both the parent and metabolite should be present.
There are some drugs that metabolize quickly and only the metabolites produce positive results. This type of metabolism can be common with certain drugs, understanding the drug detection rates is critical and should be applied to the testing results when noted.
My patient is prescribed morphine and is testing positive for hydromorphone. Does this mean the patient is also taking hydromorphone?
Not necessarily. Most patients will metabolize morphine into hydromorphone. Also, hydrocodone is partially metabolized to hydromorphone. Therefore, positive results for hydromorphone may indicate the use of either: a hydromorphone containing medication or a Hydrocodone containing medication that has completely metabolized to hydromorphone or chronic morphine therapy.
My patient is prescribed codeine and is testing positive for hydrocodone on confirmation. Does this mean the patient is also taking hydrocodone as well?
Not necessarily. There is evidence that certain people will metabolize codeine to hydrocodone. But the likelihood is very unusual, this only occurs in about <0.05% of the population and only typically at extremely high doses of codeine. Most of the population will not show hydrocodone from use of codeine. Therefore, the results should be scrutinized to ensure the proper drugs are being ingested.
My patient is prescribed tramadol and is testing negative for opiates. Does this mean the medication is not being taken correctly?
The antibodies used in the reagent for the opiate drug screening bind to traditional opiates (codeine, morphine, hydrocodone and hydromorphone) and some semisynthetic opioids (oxycodone and oxymorphone) at high doses based on their chemical structures. However, other opioids (such as tramadol, buprenorphine, fentanyl, methadone, propoxyphene or tapentadol) can have a very different chemical structure, so the opiate drug screen will not detect them. For this reason, we offer specific screens and quantitative MS testing for opiates, semisynthetic opioids and synthetic opioids.
My patient is prescribed Wellbutrin and the screen testing is positive for amphetamine. The confirmation is negative for any amphetamines, what does this indicate?
The Wellbutrin can cause cross reactivity with the amphetamine screen. We recommend performing an amphetamine confirmation to run out any amphetamine use. Aspenti can provide a list upon request of all cross reactants for this screen and all that we test.
My patient is prescribed Ritalin and the screen testing is negative for amphetamine. Why wouldn’t the Ritalin cause a positive test result?
Although Ritalin is used for the same treatment of attention deficit/hyperactivity disorder (ADHD), the structure of the drug is not similar enough to amphetamine to generate a positive test. This is also true for all of the methylphenidate analogues (Concerta and Focalin). We can perform a confirmation for the determination of Ritalin. The confirmation will report the methylphenidate and metabolite (ritalinic acid) upon completion of testing. Methylphenidate may not always present positive on confirmation. Depending on the last dose taken, methylphenidate metabolizes relativity quickly, leaving on ritalinic acid present.
My patient is prescribed oxycodone and the opiate screen is testing negative. Does this indicate that the medication is not being taken correctly?
The antibodies in the reagents used for screening opiates bind to structures that are similar in class, such as morphine or codeine. However, other semisynthetic opioids (such as oxycodone or oxymorphone) have different chemical structures, so the opiate drug screen will not detect them at normal doses. Aspenti Health offers specific screens (oxycodone) and quantitative MS testing for opiates, semisynthetic opioids and synthetic opioids to detect the use of opiate based compounds.
What is the purpose of the Validity Tests for Creatinine and Specific Gravity?
The level of drugs present in urine is influenced in part on how dilute or concentrated the urine is presenting. Creatinine and Specific Gravity tests are common markers of dilution. These tests can indicate how specimens compare with normal expected ranges. Creatinine or Specific Gravity results that are “Out-of-Range” low, may indicate intentional consumption of additional fluids to dilute the specimen. Dilution of urine samples whether intentional or not can lower the concentrations of drugs detected, potentially generating a false negative result. If the collections are unobserved, the potential for dilution can be increased.
Creatinine: A natural byproduct of muscle metabolism, is excreted by the kidneys into the urine. Typical muscle breakdown remains reasonably constant from day to day for patients, therefore the production of creatinine in a healthy person also remains constant. The normal range of creatinine in human urine is typically greater than 20 mg/dL. Although a creatinine level below the range of 70 to 130 mg/dL can be possible with normal hydration, the low creatinine level should be scrutinized based on previous submissions.
Specific Gravity: Measurement of the dissolved particulates in urine. Pure water has a specific gravity of 1.000. Normal urine specimens have specific gravities from 1.003 to 1.030. A low (abnormal) specific gravity result should be scrutinized based on previous submissions.
What is the purpose of the Specimen Validity Tests for Oxidants and pH?
Oxidants: Chemicals that have known oxidizing properties that interfere with drug testing by interacting with drugs and their metabolites. Common household oxidants such as vinegar, baking soda, liquid drain opener, detergent, bleach or hydrogen peroxide have been used along with Nitrite Chromate, Iodine and Peroxidase/H2O2 when added to a urine sample, can potentially interfere with the testing. An “Out of Range” high result for Oxidants may be an indication that the specimen has been adulterated.
pH: The use of pH for testing determines the acidity or alkalinity of a urine, on a scale from 0 to 14. Human urine generally has a pH between 4.5 and 8.2. Drug tests can be impacted by the pH of the urine when the level is too acidic or too alkaline.
Can you tell me if an insurance carrier will be accepted for reimbursement?
Yes, we can work with you to see if Aspenti Health is in network with a specific insurance carrier. Our Billing team is committed to working with your patients.
Do you need a copy of the patient’s insurance card?
Yes. Please have your patients be prepared to present their insurance card at any of our Patient Service Centers, or to submit a copy of both the front and back of the card with the specimen for processing. If faxing insurance information to us, please include the insurance carrier, ID/policy number, group number, patient name, and patient date of birth
What patient information is required for Aspenti to bill?
Aspenti requires the following information in order to bill for processed specimens:
- Patient name
- Patient date of birth
- Patient mailing address
- Social security number (for Medicare patients)
- ICD-10-CM diagnosis code
- Ordering provider
- Insurance carrier
- Insurance ID/policy number
- Subscriber information (if not the patient)
- If applicable, worker’s compensation claim ID and address, date of injury, and employer name
How do I submit patient demographic information?
All patient demographic information should be recorded on the testing requisition in the space provided. Demographic information can also be faxed to our HIPAA compliant
Does Aspenti serve uninsured or self-pay patients? How?
Yes, Aspenti serves uninsured and self-pay patients. Uninsured patients will be billed directly, as appropriate. If a patient is unable to pay for services in full, they may be eligible for our Financial Affordability in Recovery (“FAIR”) Program to reduce financial liability. Patients who have insurance, but choose not to use their insurance, must fill out a commercial Advance Beneficiary Notice (ABN) and are required to pay in full at the time services are rendered.