Testing Information

The Northern Light Laboratory Test Directory contains complete, up-to-date test information, including methodology and reporting times, collection and transportation specifications, reference intervals, test notes, and CPT codes.

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Northern Light Laboratory continually adapts our drug screen testing menu in response to changing clinical needs and changes in pain medication administration policies. Please view the following...

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Date: 06/04/2018

On June 5, 2018, our laboratory will be implementing significant changes to our urine drug screen testing menu. Please view the following attachments to stay up-to-date with Toxicology changes:

Date: 01/31/2018

On 1/31/2018, Affiliated Laboratory, Inc. will replace the current 4th generation Troponin T assay with the 5th generation Troponin T assay (Elecsys Troponin T Gen 5 STAT). This new assay is often referred to as a "high sensitivity" troponin assay for its ability to detect troponin values at or above the limit of detection in ≥50% of a reference ("normal") population. Several key differences with this new assay include:

  • Measurable values at or above the lower limit of detection in ≥ 50% of a reference ("normal") population.

    • Since 50% of "normal" individuals will have detectable troponin, serial monitoring to detect rising or falling values (aka "dynamic" pattern) is key to proper interpretation of results.

  • Extremely precise: coefficient of variation ≤ 10% at the 99th percentile upper reference limit.

    • Values should not bounce around due to background analytical "noise".

  • Whole number reporting in ng/L: measuring range is 6-10000 ng/L; values below 6 ng/L are reported as < 6 ng/L while values greater than 10000 are reported as >10000 ng/L.

  • Sex specific reference (normal) ranges (as defined by the 99th percentile upper reference limit):

    • Women: ≤ 14 ng/L

    • Men: ≤ 22 ng/L

Values greater than the 99th percentile upper reference limit by sex will be "flagged" as abnormal. The first elevated value in a series will be considered a critical value according to our current critical values policy. To distinguish this assay from other cardiac troponin assays (still in use at other sites), the new assay will be reported as "Troponin T HS". The previous 4th generation Troponin T assay will no longer be available at EMMC.

Multiple studies have demonstrated an increased sensitivity and better early discrimination of acute myocardial infarction (AMI) with "high sensitivity" assays compared with contemporary assays. This translates into an excellent negative predictive value and has allowed for a shortening of the period for "rule out" of AMI and initiation of treatment.

The Third Universal Definition of Myocardial Infarction (MI) has confirmed cardiac troponin (cTn) as the biomarker of choice. Diagnosis of MI is made with acute changes in cTn concentrations with at least one serial sample above the 99th percentile upper reference limit (URL), taken together with evidence of myocardial ischemia (symptoms, ECG changes or imaging results). To distinguish between acute and chronic cTn elevations, the Universal Definition of MI stresses the need for serial sampling to observe a rise and/or fall of cTn above the 99th percentile URL.

Troponin T is released during the process of myocyte necrosis. While cardiac specific, it is not specific for MI and detectable levels may be seen in other disease states that involve the heart muscle (e.g. arrhythmia, acute aortic syndrome, acute heart failure, hypertensive crisis, myocarditis, pericarditis, pulmonary embolism and Takotsubo cardiomyopathy). As such, ACC/EHA/AHA guidelines and the Universal Definition of MI recommend serial sampling with a rise and/or fall in troponin to distinguish between acute and chronic elevations. Markedly elevated values (>5X URL) have a high (>90%) positive predictive value for acute type 1 MI. Regardless of the etiology, however, elevated highly sensitive Troponin T values (dynamic or stable), should be considered high risk and are highly associated with increased morbidity and mortality.

A multidisciplinary team at EMMC (including representatives from cardiology, emergency medicine and laboratory medicine) has developed a diagnostic algorithm based upon the 0/3 hour rule-out algorithm according to the 2015 European Society of Cardiology (ESC) guidelines. To assist in the use and interpretation of this new assay and to allow for efficient cardiac rule-outs, we recommend that providers routinely follow this algorithm. European experience has also demonstrated even earlier cardiac rule-outs using highly sensitive troponin assays, including 0/1 hour algorithms and rule outs based upon a single highly sensitive troponin value below the limit of detection at patient presentation. It is possible that these shorter rule outs will become commonplace in the U.S. in the not too distant future.

The new cardiac troponin T assay can be ordered as part of the chest pain biomarker (troponin) protocol which includes a baseline value, additional draw at 3 hours and a possible reflexed third draw at 6 hours depending upon the degree of change between the baseline and 3 hour value (aka "delta" value). The test may also be ordered on a random basis. This test is available 24/7 and requires a lithium heparin (light green top) tube.

The following interpretative comment will chart with each result:

“Results exceeding the upper reference limit (as defined by the 99th percentile by sex) indicate myocardial injury. While cardiac specific, troponins are not specific for myocardial infarction (MI) and elevated levels may be seen in other disease states that involve the heart muscle. ACC/ESC/AHA guidelines and the Universal Definition of MI recommend serial sampling to determine a rising and/or falling pattern to distinguish an acute ischemic etiology from other etiologies. Troponin results should always be used in conjunction with clinical signs and symptoms.

The International Federation of Clinical Chemistry (IFCC) defines a high-sensitivity troponin test as one that can measure cardiac troponin (cTn) above the Limit of Detection in ≥ 50% of healthy subjects.”

If you have any questions or concerns, please do not hesitate to contact Dr. Buetens, laboratory medical director at 941-8200.

REFERENCES:

  • Elecsys Troponin T Gen 5 STAT package insert 2017-03 V1.0

  • Amsterdam, E.A, et. al. 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. September 23, 2014.

  • Twerenbold, R. et. al. Clinical Use of High-Sensitivity Cardiac Troponin in Patients With Suspected Myocardial Infarction. JACC Vol. 70, No. 8, August 22, 2017, pp. 996-1012.

  • Thygesen, K. et. al. Third Universal Definition of Myocardial Infarction. ESC/ACCF/AHA/WHF Expert Consensus Document. Circulation. October 16, 2012.

  • Roffi, M.et. al. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. European Heart Journal (2016) 37, 267-315.

Date: 08/21/2017

The new name of the confirmatory test for Lyme disease is “Western Blot for Borrelia burgdorferi Confirmation”.

We recommend following the current CDC guidelines for Lyme disease testing: order Lyme Antibody Screen w/ Reflex to Lyme Western Blot. If the Lyme antibody screen is positive or equivocal, ALI will automatically reflex to the Lyme Western blot for confirmation.

The purpose of the Lyme Western blot is to confirm positive or equivocal Lyme antibody serology results—thus, the blot should not typically be ordered as a stand-alone test.

For questions please contact Microbiology at 207-973-6979 or 207-973-6980. 

Date: 08/31/2018

At the request of the Maine Center for Disease Control and Prevention, I would like to take this time to remind you of the importance of filling out completely and accurately the BLOOD LEAD portion of the Maine Health and Environmental Testing Laboratory requisition.
 
Please note:  If venous blood is drawn and placed in a microtainer the “Venous in Microtainer” box must be checked.
 
Lead.png

This distinction is critical as it impacts how the laboratory proceeds following the detection of a high lead level. If a high lead level is obtained on a capillary blood sample a repeat venous sample is requested. If a high lead level is obtained from a venous sample the state launches an investigation.
 
I have attached a copy of the most recently updated form which was revised July 2017. Please begin to use this form if you haven’t already. I appreciate your help forwarding this memo to the appropriate staff in your facility.
 
If you have any further questions regarding Blood Lead testing please contact:  
 
Heather Grieser BS, MB (ASCP)
Microbiologist III Molecular Biology, Bacteriology and Blood Lead Sections Supervisor
Division of Disease Surveillance
Tel: (207) 287-5769
 
        OR
 
Sarah Carey
Quality Assurance Officer
Maine Center for Disease Control and Prevention
Tel: (207) 287-5679
 

Date: 10/01/2018

Please read carefully the message below from Dr. Sarah Buss, Director, Clinical Microbiology regarding changes to Flu testing beginning October 1st

Beginning October 1st, Respiratory Virus PCR (RVPCR) will be utilized as the primary method for direct detection and discrimination of influenza A/B and RSV at ALI. RVPCR is performed on NP swabs received in UTM and results are typically available the same day that the sample is received in the laboratory.

The RVPCR only detects influenza A/B and RSV. If testing for other respiratory viruses is indicated, please order a respiratory virus culture (C RV) and note on the requisition which virus is suspected. A respiratory viral culture (C RV) includes testing for influenza A, influenza B, RSV, adenovirus, parainfluenza 1-3 and rhinovirus. Enterovirus culture is a separately orderable procedure. The turn-around-time for a C RV is 48-72 hours, and they are setup Monday through Saturday. Acceptable specimens for C RV include NP swabs +/- throat swabs, bronchial washes, or nasal washes. If you would like to order a C RV on a RVPCR negative sample, please do so within 3 days of sample collection.
 
Historically, the laboratory waited until culture results from our patient population demonstrated positivity for influenza or RSV before implementing RVPCR as the primary respiratory virus testing method. This typically led to a switch from culture to PCR in November. We have not yet identified influenza or RSV in viral cultures this season: adenovirus, rhinovirus and enterovirus have been the predominant viruses isolated. We will be making the shift from culture to PCR on October 1st this year because influenza has already been detected in the state, and we want to ensure that turnaround times for influenza and RSV testing meet our clients’ expectations. 

The differences in testing are highlighted in the chart below:
 
 
Orderable: Respiratory Virus PCR (RVPCR)    Respiratory Virus Culture (C RV)
Turn-Around-Time: Typically same day or within 24 hours         Preliminary result in 48-72 hours;
            Final report issued at 10 days
Tests Included: Influenza A                             Influenza A
  Influenza B                             Influenza B
  RSV                                  RSV
                              Adenovirus
                            Parainfluenza 1
                            Parainfluenza 2
                            Parainfluenza 3
                                Rhinovirus
 
 
If you have any questions please contact the Clinical Microbiology department at 973-6980 or Dr. Sarah Buss at 973-6971.
 

Date: 01/01/2019

Effective immediately the recommended specimen type for HIV Antigen-Antibody Panel 5th Generation is EDTA PLASMA.

Serum samples will remain acceptable, but are no longer the preferred specimen type.

Samples reported as REACTIVE for HIV- 1 antibody and/or HIV-2 antibody are considered presumptively positive. PLASMA samples will automatically reflex for confirmatory testing. SERUM samples cannot be reflexed; plasma redraw is required.

Please note:  Two 4.0 mL EDTA (lavender) tubes are required. Plasma must be spun and separated from red cells within 24 hours. Transfer EDTA plasma from both tubes to one polypropylene Northern Light Laboratory transport tube and clearly label as “plasma”. Store and transport refrigerated. The Northern Light Laboratory Directory of Services (www.testmenu.com/ali) has been updated to reflect this change. 

Please distribute this memo to all of the appropriate staff at your facility.

For more information or if you have any questions please contact Clinical Microbiology at 973-6980.

Date: 01/25/2019

Beginning Friday January 25, 2019 the molecular assay used to detect Bordetella pertussis (BP PCR) at Northern Light Laboratory will be changed to an assay that detects and differentiates B. pertussis and B. parapertussis.  The test code for ordering will remain the same, but results will include the additional reportable and we will be billing for 2 CPT codes.  This change will enable us to test multiple times a day and will improve turnaround time for the BP PCR.

The new test was validated with 3 mL UTM collection tubes to simplify collection of respiratory samples (NP swabs).  We will continue to accept 1 mL UTM tubes for the BP PCR, but have begun the transition to providing only 3 mL tubes.

Like Bordetella pertussis, Bordetella parapertussis causes respiratory disease in humans.  In fact, B. parapertussis may be responsible for up to 20% of pertussis-like disease.  B. parapertussis tends to produce milder disease than B. pertussis. The pertussis vaccine has little efficacy against B. parapertussis; therefore all populations are susceptible to B. parapertussis, regardless of vaccination state.

Date: 03/01/2019

In March there will be an upgrade to our Gateway servers to TLS (Transport Layer Security) 1.2.  The Gateway server allows you access to our laboratory Directory of Services. In order to provide uninterrupted access to our on-line Directory of Services we encourage you to use this link https://www.ssllabs.com/ssltest/viewMyClient.html to determine if your current web browser is compatible with the upgrade. Look for the following message:

 compatability.jpg
 
The following browser versions DO NOT support TLS 1.2 and will no longer work:
 
  • Google Chrome 29
  • Firefox 26
  • Internet Explorer 10
  • Safari 8
  • iOS 4
  • Android 4
 
If you are using one of the above versions you will need to update your browser in order to maintain access to our Directory of Services.
 
We do not anticipate many issues with this upgrade as most users’ browsers will already be compatible.
 

Date: 10/23/2019

The Aptima Multitest Swab Specimen Collection Kit is now the preferred specimen
collection kit for extragenital (throat and rectal) Chlamydia trachomatis and Neisseria
gonorrhea testing. This is the pink-shafted swab in Multitest transport media (orange
label).
This specimen type has been FDA cleared and validated by Northern Light Laboratory for
use with the Aptima Combo 2 Ct/NG Assay. Throat and rectal swabs collected in the
Multitest Collection Kit will now be tested by Northern Light Laboratory, not sent to
ARUP Laboratories for testing as has been done in the past. This should result in a faster
turn-around time. Extragenital specimens received in the Unisex Swab Collection Kit will
still be sent to ARUP Laboratories for testing.
Parameters for collection and testing of genital specimens have not changed.
If you have any questions, please contact Microbiology at 207-973-6980 or Dr. Sarah
Buss, Microbiology Director at 207-973-6971.

Date: 11/12/2019

Effective 11/18/19, Northern Light Laboratory will perform Helicobacter pylori
Stool Antigen testing in-house. This was previously available as a send out to ARUP
laboratories. Ordering processes (PYLORI AG) and specimen requirements (stool) will
not change. For best results, patients should still avoid Proton Pump Inhibitors, H2
blockers and Bismuth for 14 days prior to running the test. The PYLORI AG test is cleared
to be used in patients of all ages for diagnosis, therapy monitoring and to confirm
eradication after treatment.
Northern Light Laboratory plans to phase out H. pylori Antibody testing in 2019
and will cease to offer the H. pylori IgG test in the new year. National reference
laboratories, including our referral laboratory, ARUP1, have already phased out H. pylori
serological tests. The most recent guidelines issued by the American Gastroenterological
Association (AGA) and American College of Gastroenterology (ACG) do not recommend
the use of H. pylori serological tests 2,3,4. Serological H. pylori tests have a low positive
predictive value and result in false positive tests, which can lead to unnecessary testing,
antibiotic use, and repeat patient visits. The American Society for Clinical Pathology’s
“Choosing Wisely” recommendation also lists serology for H. pylori as a test to avoid
because it “is no longer considered clinically useful”5. Northern Light Laboratory
encourages the adoption of these evidence-based guidelines and believes that our
clients will benefit from phase out of this outdated testing methodology. Further
information can be found via the references below.

If you have any questions, please contact Microbiology at 207-973-6980 or Dr. Sarah Buss, Microbiology Director at 207-973-6971.

References:
1. https://www.aruplab.com/infectious-disease/h-pylori
2. AGA Board, American Gastroenterological Association Medical Position Statement: Evaluation of Dyspepsia, Nov 2005, page 1754.
3. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. Chey, WD; Leontiadis, G; Howden, CW; Moss, SF MD. American Journal of Gastroenterology: February 2017 - Volume 112 - Issue 2 - p 212–239.
4. Am Fam Physician. 2018 Jan 15;97(2):135-137. H. pylori Infection: ACG Updates Treatment Recommendations. Randel A.
5. American Society for Clinical Pathology. Thirty Things Physicians and Patients Should Question. #14 Released September 14, 2016 (11-15). https://www.choosingwisely.org/societies/american-society-for-clinical-pathology/