Effective 04/01/2024, the following tests will be retired.  Please find suggested alternative tests below according to source or collection site.  PCR methodology has increased sensitivity and faster turn-around time than traditional culture or DFA methodology.  PCR testing is also more stable than culture and doesn’t pose the same supply chain and cell viability challenges, allowing for consistent reporting of patient results.  These are suggestions and not exact replacements; refer to the AEL TCM for other possibilities. Please work with your CSA, if additional help is needed to determine appropriate testing alternatives, or contact the microbiology laboratory.

Resources

1. Merckx J, Wali R, Schiller I, Caya C, Gore GC, Chartrand C, Dendukuri N, Papenburg J. Diagnostic Accuracy of Novel and Traditional Rapid Tests for Influenza Infection Compared with Reverse Transcriptase Polymerase Chain Reaction: A Systematic Review and Meta-analysis. Ann Intern Med. 2017 Sep 19;167(6):394-409.
2. Vos LM, Bruning AHL, Reitsma JB, Schuurman R, Riezebos-Brilman A, Hoepelman AIM, Oosterheert JJ. Rapid molecular tests for influenza, respiratory syncytial virus, and other respiratory viruses: a systematic review of diagnostic accuracy and clinical impact studies. Clin Infect Dis. 2019 Jan 28. doi: 10.1093/cid/ciz056. [Epub ahead of print]

Effective 03/18/2024, the following urine collection devices will be required for the tests below:

AEL is pleased to offer a new Urine Culture specifically for pregnant individuals.

The order code is M180, Prenatal Urine Culture with reflex to Group B Strep (GBS) ID for any concentration of Group B Strep seen in the culture.

Identifying any level of colonization of Group B Strep during pregnancy is important for the health of the mother and of the neonate after delivery. 

Group B Strep can pass from a pregnant woman to her fetus during labor. This is a rare event affecting only 1 to 2 pregnancies out of 100 when the mother does not receive treatment with antibiotics during labor. The chance of a newborn being affected is much lower when the mother receives treatment.

The Prenatal Urine Culture test is exactly like the Routine Urine Culture, except that all suspect Group B colonies are confirmed and reported.

If you have any questions regarding this test, please call Dr. Jess Evans at 901.432.8605. 

Thank you for your continued support of AEL.

Dear Valued Client,

American Esoteric Laboratories (AEL) is pleased to announce that all providers may now utilize AEL for pathology and clinical laboratory testing needs for all BlueCare Tennessee members. With recent passage of the “Any Willing Medical Lab Provider” legislation, effective July 1, 2023 providers are no longer required to use a single laboratory for pathology and clinical laboratory services for BlueCare Tennessee members.

Key benefits to this change include:

• Enhanced pathology and clinical laboratory testing services with local AEL customer service
• Improved testing turnaround times utilizing AEL’s Memphis and Knoxville testing locations
• Improved office efficiencies as all pathology and clinical laboratory specimens can now be processed and resulted by AEL, thus preventing splitting samples between multiple laboratories

If you have questions or would like an AEL representative to contact you, please call 1-800-423-0504 or visit our website at ael.com (select “Become an AEL Client” under the “Clinicians” tab).

Thank you for allowing AEL to be your laboratory of choice!

Specimen collection for specimen types recommended by the CDC for Chlamydia, Gonorrhea, and Trichomonas testing

Beginning August 2023, American Esoteric Laboratories (AEL) is pleased to announce that we will be transitioning our swab collection devices and swab specimen testing for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) NAAT testing. 

This testing will be transitioned to the Roche COBAS® 6800/8800 platform, which is an FDA-approved PCR method shown to be analytically equivalent to current testing, with improved workflows in the laboratory. 

Clients will no longer be supplied with Aptima® Purple collection devices after current inventory is depleted and orders will be fulfilled with COBAS® PCR Dual Swab kits.  Aptima® Orange collection devices will still be available for order for applicable tests (U294 Bacterial Vaginosis, U296 Vulvovaginal Candidiasis, U295 CV/TV, VSTI Vaginitis and Sexually Transmitted Infections PCR).

During the transition, Aptima® Orange and Purple collection devices will continue to be run on the Hologic® platform, and Roche COBAS® PCR Dual Swab Kit collection devices will be run on the Roche COBAS® platform without delays to testing.

Current test codes and CPT will remain the same.

Tests that will be affected include:

• U077- Gonorrhea Amplified
• U074- Chlamydia Amplified
• U078- Gonorrhea and Chlamydia Amplified
• U178- Trichomonas Amplified
• M760 Culture, Blood Pediatric

• U079- Leukorrhea Panel (GC, CT, Trich)

For clients wishing to order U294 Bacterial Vaginosis, U296 Vulvovaginal Candidiasis, or U295 CV/TV with Gonorrhea, Chlamydia, and Trichomonas, we suggest ordering VSTI Vaginitis and Sexually Transmitted Infections PCR.  This test requires an Aptima® Orange collection device.

References

COBAS® CT/NG Qualitative nucleic acid test for use on the COBAS® 6800/8800 Systems. Package Insert. Roche Diagnostics®. 07998007001-04EN.

COBAS® TV/MG Qualitative nucleic acid test for use on the COBAS® 6800/8800 Systems. Package Insert. Roche Diagnostics®. 08308535001-03EN.

https://www.cdc.gov/mmwr/preview/mmwrhtml/rr6302a1.htm

Beginning June 19, 2023, American Esoteric Laboratories (AEL) is pleased to announce that we will be transitioning our urine collection devices and urine specimen testing for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) NAAT testing. 

This testing will be transitioned to the Roche COBAS® 6800/8800 platform, which is an FDA-approved PCR method shown to be analytically equivalent to current testing, with improved workflows in the laboratory.  COBAS® PCR Urine Kit collection devices will begin to be distributed on June 19, 2023.  Clients will no longer be supplied with Aptima® Urine (Yellow Aptima) collection devices after current inventory is depleted, and orders for urine collection kits will be fulfilled with COBAS® PCR Urine kits.

During the transition, Aptima® Urine (Yellow Aptima) collection devices will continue to be run on the Hologic® platform, and Roche COBAS® PCR Urine Kit collection devices will be run on the Roche COBAS® platform without delays to testing.

Current test codes and CPT will remain the same.

Tests that will be affected include:

• U077- Gonorrhea Amplified
• U074- Chlamydia Amplified
• U078- Gonorrhea and Chlamydia Amplified
• U178- Trichomonas Amplified

• U079- Leukorrhea Panel (GC, CT, Trich)

A transition of swab collection devices will occur at a later date, but we will continue to offer Hologic® swab testing for those clients wishing to order GC, CT, and Trich with Bacterial Vaginosis and Candidiasis (Vaginal) PCR Testing.

References

COBAS® CT/NG Qualitative nucleic acid test for use on the COBAS® 6800/8800 Systems. Package Insert. Roche Diagnostics®. 07998007001-04EN.

COBAS® TV/MG Qualitative nucleic acid test for use on the COBAS® 6800/8800 Systems. Package Insert. Roche Diagnostics®. 08308535001-03EN.

https://www.cdc.gov/mmwr/preview/mmwrhtml/rr6302a1.htm

When collecting Pap or sexually transmitted infection (STI) testing specimens, use of warm water is preferred over any lubricant. If lubricants must be used, apply no more than a pea size amount to the outer curve of the speculum, avoiding any application near the edges or lip of the speculum, and smoothly insert without withdrawing and reinserting. Be vigilant for and avoid lubricant contaminating or coating the sampling area.

Recommended Lubricants

The following lubricants are compatible with Hologic Aptima® and Roche cobas® molecular platforms. In addition, those provided in this recommended list have decreased interference with the Hologic Thinprep® Pap smear method.

Lubricants Not Recommended

Please avoid using any products including lubricants, creams, gels, and hygiene products containing CARBOMERS prior to collection of urogenital NAAT testing specimens. The lubricants that should be avoided prior to urogenital specimen collection are given below.

Dear AEL Client

Effective 3/6/2023, American Esoteric Laboratories will update our process for susceptibility determination on positive blood cultures to align with Clinical and Laboratory Standards Institute (CLSI) standards.  Susceptibility testing for a positive blood culture obtained within 72 hours of an initial positive blood culture will not be performed if the organism identification and colony morphology are the same. 

Currently, if a patient has a positive blood culture collected within 24 hours of a previous positive blood culture and the organism identification and colony morphology are the same as the original culture, a comment is added to “refer to previous susceptibility”.  No additional susceptibility workup is performed since the susceptibility is referred to the original culture.  This rule only applies if the pathogen identification and colony morphology match the previous blood culture results.  If a pathogen does not have the same identification or colony morphology, susceptibility workup will be performed.

Studies have shown that blood culture pathogens do not acquire additional antibiotic resistance mutations within 3 days, with most studies suggesting 5 days before additional resistance emerges. 

These referral changes will reduce turnaround time and cost to clients and patients.  Additional susceptibility requests can be placed as an “add on” through your outside lab or customer service (901-405-8200).  Additional questions should be directed to customer service.      

Tests that will be affected include:

• M700 Culture, Blood
• M710 Culture, Blood 2^nd Specimen
• M790 Culture, Blood Positive Bottle
• M750 Culture, Blood Manual
• M760 Culture, Blood Pediatric
• M770 Culture, Blood Pediatric, 2^nd Specimen

The following CPT code updates were effective January 1, 2023.  A summary of CPT code changes for laboratory tests is provided to supplement your billing and coding notices.  Please contact your AEL representative for further questions.

Effective 12/19/2022, the following urine collection devices will be required for the following tests:

Urinalysis with microscopic, reflex to culture URMRFX/K010   Urine Culture C urine (M100)	Gray Top Urine (GTU) and Yellow Top Urine with Preservative *Urines for culture only, a GTU is required **For pediatric urines with insufficient volume, please send sterile cup
Urinalysis Testing URM/K004, URCH/K015	Yellow Top Urine with Preservative
Urine Chemistry Testing	Yellow Top Urine, no Additive
Toxicology Testing Chain of Custody	Urine cup collection kit
Toxicology Testing, other than Chain of Custody	Yellow Top Urine, no Additive

For any urine test not listed above, please refer to the test Collection Manual online for the specific collection and submission instructions.

Effective immediately, American Esoteric Laboratories (AEL) will be offering the ARIES^® MRSA Assay. The ARIES^® MRSA Assay is an integrated, real-time, polymerase chain reaction (PCR)-based qualitative, in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA in nasal swabs from patients at risk for nasal colonization.

The CDC estimates that approximately one in fifty people in the U.S. are colonized with MRSA in their nose.¹ Further, individuals who are colonized are four times more susceptible to infection.² MRSA is commonly found in hospitals and healthcare facilities, where it can cause severe health problems, including pneumonia, bloodstream infection, sepsis, and even death.¹ The transmission of MRSA and the risk of MRSA infection (including MRSA bacteremia) can be addressed more effectively if measures are taken to identify and treat MRSA carriers to reduce the risk of nosocomial transmission. This requires screening of patient populations for MRSA colonization either before or on admission to identify whether there is a need for a decolonization regimen.

Further test details are below:

Bagging

Please refer to the guidelines below when sending in multiple samples with one requisition.

• If multiple sample types are collected using one requisition, please keep all samples bagged together, i.e., CMP, CBC, C URINE using the SST, PURPLE TOP TUBE (EDTA) and Urine cup can all go into one primary specimen bag. Recommend urine cups are bagged in a separate bag and placed inside bag with blood samples.
• If you would like to bag certain samples separately, please place them on different requisitions.

An exception for bagging together would be specimens that  must be stored and transported at different temperature requirements.

Critical Frozen Specimens

Please refer to these guidelines when sending in critical frozen samples when there may be other tests on the same patient that do not require freezing.

• Make a copy of the requisition.
• Affix a green “Frozen Match-up” sticker (shown below) to the copy of the requisition, and the original requisition.

• Place a green “Frozen” sticker (shown below) on the specimen.

• Place the copy of the requisition in the specimen bag with the labeled frozen sample.

Labeling Aliquot or Unmarked Transport Tubes

In order for the laboratory staff to handle the appropriate specimens for the testing requested, indicate specimen type on the transport tubes or label transport tubes with the specimen type label aliquoted into the tube.

Serum Transport tubes- place a Serum label on the tube or write serum on the transport tube. If serum was obtained from a red top please indicate such on transport tube.

Urine Transport tubes (not YTU’s) - any urine that is aliquoted from its original container and poured in a non-specific transport tube, label with a Urine label or write urine on the tube.

Plasma Citrate- any transport tube where Citrated plasma has been aliquoted, place a Citrate label on the tube or write citrate on the transport tube.

Plasma EDTA- any transport tube where EDTA plasma has been aliquoted, place an EDTA label on the tube or write EDTA on the transport tube.

Fluids- Clearly indicate fluid source on specimen and requisition.

Special Collection tubes- if any special collection tubes are required (Royal Blue serum/plasma, ACD A/B, Heparin, Protease Inhibitor, GI preservative) indicate specimen type on the transport tubes.  

*Please refer to the Test Collection Manual for specimen collection, handling, and transport requirements

http://testmanual.sonichealthcareusa.com/pseudoaep/tcm/csp/TCM.csp

**All above labels can be ordered through AEL Supply Department at [email protected] or contact your AEL Client Service Representative.

Dear AEL Client,

Effective September 26, 2022, AEL will update testing for Bacterial Vaginosis and Vulvovaginal Candidiasis. Tests Bacterial Vaginosis PCR, U160 and Candida by PCR, U170 will be retired, with new test offerings below.  We expect these changes to reduce turnaround time while providing the same clinically actionable results for your patients.

Test offerings will include:

Please refer to the AEL Test Collection Manual (www.ael.com/test-menu)  for individual targets used for interpretation and reporting.

Dear AEL Client,

We are pleased to announce our offering of the Aptima® vaginitis panel to detect bacterial vaginosis (BV), candida vaginitis (CV) and Trichomonas vaginalis (TV). The Aptima® BV and Aptima® CV/TV assays are rRNA-based nucleic acid amplification tests (NAATs) that collectively provide an objective, comprehensive and accurate method for diagnosing the cause of vaginitis.^1,2

Vaginitis Is the Leading Reason for OBGYN Visits³

Most women experience an episode of vaginitis at least once in their lifetime.⁴ The vast majority (90%) of vaginitis is caused by BV, CV and TV infections, either individually or in combination.⁵ Mixed infections and overlapping symptoms can make clinical diagnosis of this common disease state challenging, and many cases are not successfully resolved the first time.^6,7

NAAT Results In More Accurate Diagnosis and Better Clinical Management⁴

The Amsel criteria and Nugent scoring are subjective which can lead to misdiagnosis and treatment, and DNA probe testing can lead to inaccurate or incomplete results.^9,10 NAATs detect mixed infections more frequently than clinical microscopy or probe testing.¹⁰ Each vaginitis etiology has distinct treatment, so an accurate diagnosis is imperative in identifying the appropriate care.

Seamlessly Integrate Aptima Vaginitis Assays Into Your Office

The versatility of the Aptima® Multitest swab simplifies testing for sexual and vaginal health by supporting testing for vaginitis, either alone, or from the same vaginal sample taken for other infections and disease states.* This added convenience reduces patient callbacks for re-collection when reflex or add-on testing is ordered and simplifies sample collection.

As your laboratory partner, we strive to offer you high-performance tests for disease detection. We look forward to working with you to provide this important panel to your patients.

Please call your AEL rep for more information.

* Refer to individual assay package inserts for cleared specimen types and performance claims.

References: 

1. Aptima BV Assay [package insert]. AW-18811, San Diego, CA; Hologic, Inc., 2020
2. Aptima CV/TV Assay [package insert]. AW-18812, San Diego, CA; Hologic, Inc., 2020
3. Kent HL. Epidemiology of Vaginitis. Am J Obstet Gynecol. 1991 Oct;165(4 Pt 2):1168-76.
4. Goje OL. Advancing the diagnosis of vaginitis. CLPMag, 2020.
5. Sobel J. Approach to females with symptoms of vaginitis. UpToDate. Updated May 25, 2021. Accessed August 2021. www.uptodate.com
6. Anderson MR, Klink K, Cohrssen A. Evaluation of vaginal complaints. JAMA. 2004;291(11):1368–1379. doi:10.1001/jama.291.11.1368.
7. Bradshaw CS, Morton AN, Hocking J, et al. High recurrence rates of bacterial vaginosis over the course of 12 months after oral metronidazole therapy and factors associated with recurrence. J Infect Dis. 2006;193(11):1478–1486. doi.org/10.1086/503780.
8. Belley-Montfort L, Lebed J, Smith B, et al. Sensitivity of the Amsel’s Criteria compared to the Nugent Score in absence and in presence of Trichomonas vaginalis (TV) and/or Candida SPP among women with symptomatic vaginitis/vaginosis. Sex Transm Infect: first published as 10.1136/sextrans-2015-052126.290 on 18 May 2015.
9. Cartwright CP, Lembke BD, Ramachandran K, et al. Comparison of nucleic acid amplification assays with BD affirm VPIII for diagnosis of vaginitis in symptomatic women. J Clin Microbiol. 2013;51(11):3694. doi:10.1128/JCM.01537-13
10. Schwebke JR et al. Diagnostic performance of a molecular test versus clinician assessment of vaginitis. J Clin Microbiol. 2018;56(6). doi:10.1128/JCM.00252-18.

Effective July 18, 2022, AEL will offer testing for detection of Orthopoxvirus, including monkeypox virus (MPXV). This test can be performed on clinical specimens collected during the acute/symptomatic phase of illness from patients suspected of Monkeypox. Sonic Healthcare USA was selected by the CDC as one of five laboratories to develop an FDA-approved, high-complexity NAAT (RT-PCR) molecular assay to identify MPXV. 

Diagnostic/Laboratory Testing Guidelines

• Brush active lesion vigorously with two separate sterile swabs. Use synthetic swabs, i.e., nylon, polyester, or Dacron. Do not use cotton swabs.
• Break off or cut the tip of each swab into a screw-capped tube with O-ring.
• ***Each swab should be placed in a separate tube.  Two tubes per lesion.***
• If multiple lesions are to be tested, a separate order must be submitted for each lesion (2 swabs per lesion). CDC recommends testing 2-3 lesions total.
• Refrigerate specimens within an hour after collection.
• Specimen stability:  Refrigerated--7 days;  Frozen--1 month
• Expected Turn Around:  3-4 days
• CPT Code:  87593
• Methodology:  Real-Time Polymerase Chain Reaction (RT-PCR)

If a patient is being evaluated for Monkeypox and additional viral lesion testing will be performed (HSV/VZV DFA or viral culture), please alert AEL Customer Service before sending the specimen. Please send a separate specimen marked with a BIORISK label and/or a BIORISK notification sheet included with this document.

Monkeypox: Interim Guidance from the CDC for Healthcare Providers

• Monkeypox virus details:
  • To date, over 1800 human infections in the US involving 43 states
  • Orthopoxvirus genus, which includes variola/smallpox, cowpox. MPXV is NOT related to varicella/chickenpox/shingles.
  • Resistant to drying, heat, and pH. Materials with MPXV may remain infectious for months to years.
• Incubation 6-13 days, up to 21 days.
• Signs/Symptoms
  • Fever, headache, swollen lymph nodes (which may differentiate it from smallpox), respiratory symptoms, and GI symptoms, including diarrhea.
  • Characteristic Rash - See photos and complete description below.
    • May look like pimple or blister on face, inside of mouth, genitals, other body parts.
• Laboratory findings – leukocytosis, elevated AST & ALT, low BUN, low albumin.
• Differential diagnosis - Smallpox, chickenpox/shingles, measles, bacterial skin infections, scabies, medication allergies, HSV, and syphilis.
• Spread
  • Direct contact with the rash, respiratory secretions during prolonged face to face contact, intimate contact, fomites, placental transfer, animals handling. Spread from rash possible up to several weeks.
• Prevention
  • Avoid contact, good hygiene, PPE.
  • Vaccine – JYNNEOS/Imvanex: inactive virus, FDA approved.
• Complications – bacterial infection, sepsis, dehydration, diarrhea, encephalitis.
• Treatment – For select cases, smallpox anti-viral (TPOXX/tecovirimat) maybe indicated, especially for highly vulnerable populations.

Criteria to Guide Evaluation of Monkeypox Cases

Epidemiologic Criteria – Within 21 days of illness onset:

• Reports having contact with a person or people with a similar appearing rash or who received a diagnosis of confirmed or probable monkeypox OR
• Had close or intimate in-person contact with individuals in a social network experiencing monkeypox activity, this includes men who have sex with men (MSM) who meet partners online or at social events (e.g., a bar or party) OR
• Traveled outside the US to a country with confirmed cases of monkeypox or where Monkeypox virus is endemic OR
• Had contact with a dead or live wild animal or exotic pet that is an African endemic species or used a product derived from such animals (e.g., game meat, creams, lotions, powders, etc.)

Exclusion Criteria – A case may be excluded as a suspect, probable, or confirmed case if:

• An alternative diagnosis can fully explain the illness OR
• An individual with symptoms consistent with monkeypox does not develop a rash within 5 days of illness onset OR
• A case where high -quality specimens do not demonstrate the presence of Orthopoxvirus or Monkeypox virus or antibodies to orthopoxvirus.

Characteristic Rash

• Deep-seated and well-circumscribed lesions, often with central umbilication.
• Lesion progression through specific sequential stages—macules, papules, vesicles, pustules, and scabs.
• May be confused with other diseases that are more commonly encountered in clinical practice (e.g., secondary syphilis, herpes, and varicella zoster).
• Historically, sporadic accounts of patients co-infected with monkeypox virus and other infectious agents
  (e.g., varicella zoster, syphilis) have been reported, so patients with a characteristic rash should be considered for testing, even if other tests are positive.

References:

1. Case Definitions for Use in the 2022 Monkeypox Response. Centers for Disease Control and Prevention website. Accessed June 2022. https://www.cdc.gov/poxvirus/monkeypox/clinicians/case-definition.html 
2. U.S. Monkeypox Outbreak 2022: Situation Summary. Centers for Disease Control and Prevention website. Accessed June 2022.
3. Brown K, Leggat PA. Human Monkeypox: Current State of Knowledge and Implications for the Future. Trop Med Infect Dis. 2016;1(1):8. Published 2016 Dec 20. doi:10.3390/tropicalmed1010008

Dear AEL Client:

Please note that the following Coagulation Panels when abnormal will automatically reflex to Coagulation Consult by a Pathologist. The consult will be performed, reported, and charged. Please do not request a consult or add on a consult to these panels.

If a coagulation consult is needed for the Von Willebrand Panel, please order I241 VWP Consult at the time of the order or as an add on. The consult will be completed, reported and charged.

The following panels do not include a consultation. The prior code B050 Baptist Coagulation consult is no longer orderable.

Please contact your AEL Client Service Representative for additional information or questions. We appreciate your continued support.

The following CPT code updates were effective January 1, 2022.  A summary of CPT code changes for laboratory tests is provided to supplement your billing and coding notices.  Please contact your AEL representative for further questions. 

On November 30, 2021, the U.S. SARS-CoV-2 Interagency Group (SIG), which includes the Centers for Disease Control and Prevention (CDC), the National Institutes of Health, the Food and Drug Administration (FDA), and Health and Human Services (HHS), classified the Omicron variant as a Variant of Concern. The current understanding of the Omicron VOC at this time is as follows: 

• Preliminary data from South Africa suggest that the mutations to the receptor binding protein of the variant virus will confer increased infectivity.
• Preliminary studies indicate that there are no unusual symptoms associated with Omicron variant infection, and as with other variants, some patients are asymptomatic. Symptoms may be milder in persons who have been vaccinated or previously infected with SARS CoV-2.
• The presence of mutations in the SARS-CoV-2 virus in a patient sample has the potential to impact test performance. The impact of mutations on a test's performance is influenced by several factors, including the sequence of the variant, prevalence of the variant in the population, and the design of the test including the analytic target. Indeed, tests which interrogate for a single target are particularly vulnerable.

Laboratory evaluation of SARS-CoV-2, including the Omicron Variant of Concern, at American Esoteric Laboratories:

• All high-throughput SARS-CoV-2 molecular assays performed at American Esoteric Laboratories are designed to interrogate for multiple targets of the viral genome and have received emergency-use authorization by the FDA.
• Based on in silico analysis, all molecular assays are expected to detect the Omicron variant of concern.
• For some assays, including the Thermo Fisher Taq Path PCR assay, a specific deletion in the spike (S) gene (Δ69-70) in the Omicron variant results in an S-gene dropout, also referred to as an S-gene target failure (SGTF).
  • The S-gene target failure pattern may be identified in the Omicron variant (BA.1 sub-lineage), but this pattern is also seen in previously identified variants (e.g., Alpha).
  • Since these tests are designed to detect multiple genetic targets, the overall test sensitivity is not significantly impacted.
  • The S-gene target failure pattern provides a signal that the Omicron variant (BA.1) may be present and that the isolate may be suitable for sequencing and/ or other public health considerations.
  • The S-gene target failure pattern does not necessarily mean that an individual with SARS-CoV-2 has the Omicron variant.
• For clients who have concerns about antigen or other point of care assays that they provide, the assay manufacturer can be contacted for information about expected analytical performance impact.

References: 

• New SARS-CoV-2 Variant of Concern Identified: Omicron (B.1.1.529) Variant. Health Alert Network 00459. December 1, 2021.
• SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests. U.S. Food and Drug Administration. December 6, 2021.
• Technical Brief: Predicted Impact of Variants on Abbott SARS-CoV-2/COVID-19 Diagnostic Tests. Abbott. November 26, 2021
• Impact of SARS-CoV-2 mutations (including Omicron) on the cobas® SARS-CoV-2 and cobas® SARS-CoV-2 & Influenza A/B Tests for use on the cobas® 6800/8800 Systems and the cobas® SARS-CoV-2 and cobas® SARS-CoV-2 & Influenza A/B Tests for use on the cobas® Liat® System. Roche Client Bulletin. November 30, 2021.
• Thermo Fisher Scientific Confirms Detection of SARS-CoV-2 in Samples Containing the Omicron Variant with its TaqPath COVID-19 Tests. Thermo Fisher Client Bulletin. November 29, 2021.

In response to recommendations from the National Kidney Foundation and American Society of Nephrology (NKF-ASN) Task Force on estimated glomerular filtration rate (eGFR), effective January 10th, 2022, American Esoteric Laboratories will adopt the single CKD-EPI Refit equation to replace the separately reported eGFR – Black and eGFR – non-Black calculations for all serum creatinine measures.

The Task Force (TF) was established in 7/2020 to consider inequity in diagnosis, management and outcomes of chronic kidney disease in Black patients including recognition and management of kidney-disease risk factors, comorbidities, and progression to kidney failure. Additionally, the deliberations were informed by the significantly higher prevalence of hypertension and decline in measured GFR at an earlier age and steeper slope for Black vs. non-Blacks associated with lower rates of nephrology referral, dialysis options and transplantation. The NKF-ASN TF committed to a GFR estimate approach that recognized the ambiguity of racial distinction and the substantial diversity in the US and that promoted equity without creating new or worsening preexisting disparities.

As a part of the TF, the CKD Epidemiology Collaboration conducted a meta-analysis of 10 previously published studies and validated a new single equation for eGFR based on creatinine, the CKD-EPI Creatinine Refit (CKD-EPIcr_R) in a dataset of 12 studies. The new equation balanced performance equally between Black and non-Black study participants. With input from more than 90 experts in the field and public members, the Task Force recommended:

1. Immediate implementation of the new 2021 CKD-EPIcr_R calculation for eGFR based on creatinine, to replace separately reported race-based eGFR’s.

2. National efforts to facilitate routine and timely use of cystatin C, to confirm eGFR in adults who are at risk for or have CKD. Cystatin C can be used alone or paired with simultaneous creatinine measure for the most accurate eGFR (eGFRcr-cys_R).

The TF notes that measured GFR (usually creatinine clearance) may have a certain degree of inaccuracy (incomplete collection, medications, etc.) and recommends that clinical decision-making be based on trends in eGFR values.

Assessment for albuminuria, as recommended in the Kidney Disease Improving Global Outcomes (KDIGO) guidelines should be considered essential to assessment of kidney disease.

To facilitate transition and inform patients, NKF offers an eGFR Summary for Ordering Clinicians
(https://www.kidney.org/sites/default/files/02-10-8361_icb_egfr_summary_flyer.pdf) .

Additional references are given below:

• Delgado C et al. A Unifying Approach for GFR Estimation: Recommendations of the NKF-ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Disease. Am J Kidney Dis. 2021 Sep 22:S0272-6386(21)00828-3.

• Inker LA, Eneanya ND, Coresh J, et al. New creatinine- and cystatin C–based equations to estimate GFR without race. N Engl J Med. 2021 Sep 23.doi: 10.1056/NEJMoa2102953. Online ahead of print.

Printable Version

Austin, TX – April 19, 2021

Sonic Healthcare USA (Sonic), a leading provider of laboratory services in the United States, was recently included as a laboratory testing partner for the Rockefeller Foundation’s K-12 National Testing Action Program (NTAP). The NTAP program introduces school districts in the United States to leading testing companies supporting COVID-19 testing for K-12 students.

Over the last year, Sonic has been one of the leading commercial laboratories performing COVID-19 testing throughout its network of clinical laboratories and pathology practices in the United States. Sonic continues to focus on and support specific underserved patient populations and government-funded programs in partnership with local government and public health agencies to improve testing access for these communities.

Sonic is expanding testing capacity for K-12 testing programs at the following laboratory locations: American Esoteric Laboratories, located in Memphis, TN; Bernhardt Laboratories, located in Jacksonville, FL; Clinical Labs of Hawaii, located in Honolulu, HI; Clinical Pathology Laboratories, located in Austin, TX; East Side Clinical Laboratory, located in Providence, RI; GPA Laboratories, located in Greensboro, NC; LMC Pathology Services, located in Las Vegas, NV; Seacoast Pathology, located in Exeter, NH; Sunrise Medical Laboratories, located in Hicksville, NY; and WestPac Labs, located in Santa Fe Springs, CA.

“We are honored and privileged to be included amongst the leading companies supporting COVID-19 testing efforts,” said Jerry Hussong, MD, MBA, Chief Executive Officer, Sonic Healthcare USA. “Supporting the reopening of schools is paramount to COVID-19 recovery efforts; it is our social responsibility to collaborate with public health officials, school officials, and other leading private and public sector organizations. Collectively, we can quickly respond to the needs of our local communities,” added Dr. Hussong.

About Sonic Healthcare USA

Sonic Healthcare USA is a subsidiary of Sonic Healthcare Limited, one of the world's largest medical diagnostic companies, providing laboratory services to medical practitioners, hospitals and community health services, with operations in eight countries, on three continents and providing care to over 100 million patients each year. Sonic Healthcare USA is a leading provider of state-of-the-art laboratory services and pathology practices throughout the USA with eight operating divisions and nearly eight thousand US- based employees, 330 Pathologists and serving over 30 million patients per year. Sonic Healthcare USA operates under a federated business model that emphasizes medical leadership and community-based testing services to provide outstanding quality and service to the doctors and patients that they serve. For more information, visit the Sonic Healthcare website at www.sonichealthcareusa.com.

MEDIA CONTACTS:

Sonic Healthcare USA

Dr. Jerry Hussong, MD, MBA

Chief Executive Officer

[email protected]

512.531.2216

New Regulation Regarding Patient Access to Test Results

Austin, TX – September 2, 2020

Today, Sonic Healthcare USA (Sonic) was awarded a contract from the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics Advanced Technology Platforms (RADx-ATP) initiative. The contract involves funding to expeditiously ramp up COVID-19 testing to 166,000 tests per day at nine of Sonic’s network of high-throughput laboratory testing locations, giving Sonic the capacity to service geographies across the United States.

Sonic was also selected by the U.S. Department of Health and Human Services (HHS) as one of two commercial laboratories to receive critical laboratory equipment to support the expansion of COVID-19 testing. Through these investments, aggressive expansion has begun at the following Sonic COVID-19 testing locations: American Esoteric Laboratories (AEL), located in Memphis, TN, Clinical Pathology Laboratories (CPL), located in Austin, TX and WestPac Labs located in Santa Fe Springs, CA. The added capacities will be coming online beginning this week.

While the NIH contract amplifies Sonic’s existing COVID-19 testing effort for all populations, a significant component includes improving testing access for underserved communities. Sonic has been supporting these populations directly and in partnership with local government and public health agencies. Funding from the RADx initiative will be used to develop comprehensive access with measurable coverage assessment for these populations. The RADx initiative complements Sonic’s current commitment to prioritize services to the most vulnerable and high-risk patients. Servicing these populations will continue to be a central part of our testing strategy.

“In response to the urgent pandemic demands, the partnership with the NIH and HHS, provides us access to technologies, instrumentation and resources necessary to rapidly increase the scope and expedite the timeline of our current capacity expansion plans,” said Dr. Jerry Hussong, MD, MBA, the Chief Executive Officer of Sonic HealthcareUSA. “The new testing capacity will increase patient access to COVID-19 diagnostic testing across the country with timely result delivery,” added Dr. Hussong.

This project is supported by the NIH Rapid Acceleration of Diagnostics (RADx) program and has been funded in whole or in part with federal funds from the National Institutes of Health Office of the Director, Department of Health and Human Services, under Contract No. 75N92020C00027.

March 25, 2020

The Tennessee Department of Health (TDH) is providing this update regarding the COVID-19 outbreak. 

Cases in healthcare workers or in your facility: 

As COVID-19 spreads, healthcare related exposures are increasing. We have developed the guidance below for individual providers and facilities on how to respond if there is a case (or suspected case) in a healthcare staff member. 

• Guidance for healthcare providers diagnosed with COVID-19 

Communicating with patients: 

TDH has developed resources that may be useful in communicating with your patients. These documents provide actionable steps and guidance for those who may have been exposed, those awaiting test results, and those diagnosed. 

• What to expect if you were possibly exposed to COVID-19 
• What to expect after being tested for COVID-19 
• What to expect after being diagnosed with COVID-19 

Testing guidance: 

Not every patient with respiratory illness needs to be tested for COVID-19. Most people have mild illness and are able to recover at home, and there is no treatment specifically approved for this virus. 

TDH’s triage and assessment criteria are available here. We continue to encourage patients to seek care first from their usual site of care and we are working to enable providers to accommodate that need. We know that shortages of PPE, testing supplies, and testing sites are common. A number of healthcare facilities have established remote assessment sites which can be accessed across the state. While we are looking at every opportunity to fix those problems, permanent solutions are not immediately available and we need your help in addressing these shortages by implementing strategies to conserve PPE and by minimizing unnecessary tests. While providers do not need to consult with public health before sending a test to a commercial lab, providers should prioritize testing for individuals who are the sickest, have co-morbid conditions putting them at higher risk, or who are healthcare workers. Prioritizing tests for those individuals is essential to improving turnaround times while there is national shortage of test reagents and supplies, among public health and commercial laboratories. 

Counterfeit COVID-19 tests:

The Food & Drug Administration and U.S. Immigrations and Customs Enforcement Homeland Security Investigations team are monitoring reports about counterfeit COVID-19 testing kits. At this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19. More information can be found here. TDH encourages use of reputable and known testing resources to prevent retesting and delays in healthcare and public health actions. 

If you believe you may have received a counterfeit COVID-19 test, you can report it to the HSI Tip Line at (866) 347-2423 or via an anonymous online form. 

Reporting COVID-19 cases and deaths: 

COVID-19 cases and deaths are immediately reportable to TDH and full guidance is available online here.

Cases: Healthcare providers have 3 options for reporting laboratory confirmed cases: 

• Fax the PUI Form and a copy of the positive laboratory report to 615-741-3857 
• Call the TDH COVID-19 call center between 8am-8pm, 615-741-7247 
• Submit an electronic Morbidity Report* 

*If you already report diseases or conditions to TDH via Morbidity Reports, you can continue to do this for COVID-19 positive labs. These are electronically submitted to NBS here. 

Death: Providers have 2 options for reporting deaths in a suspected or laboratory-confirmed COVID-19 case among their patients or in their facility: 

• Providers can inform their county medical examiner of the death, and the county medical examiner will then notify the Office of the State Chief Medical Examiner. 
• Fax the PUI Form (noting the field indicating death) and a copy of the positive laboratory report to 615-741-3857. An updated form can be submitted indicating death. 

Elective dental and medical procedures:

Governor Lee has signed Executive Order 18, which states that dental service providers shall not perform any non-emergency dental or oral procedures. All hospitals and surgical outpatient facilities in the State of Tennessee shall not perform non-essential procedures, which include any medical procedure that is not necessary to address a medical emergency or to preserve the health and safety of a patient, as determined by a licensed medical provider. Ambulatory providers should continue to treat patients, preferably via telehealth and telemedicine when possible to minimize exposure risks. 

This order will preserve staff, personal protective equipment, and patient care supplies, ensure staff and patient safety, and expand available capacity. 

Telehealth:

There has been a rapid expansion in reimbursement opportunities for telehealth, now including home-based telehealth coverage by nearly every plan in the state during this time of public health response. Please utilize telehealth and telephone triage as much as possible for both sick and well patients. This is critical to minimize public exposure to illness and to optimize capacity for routine and emergent are. Several resources have been put together that I’ve listed below. Utilization of telehealth and telephonic management should be optimized in all settings. 

• CMS https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet 
• TMA https://www.tnmed.org/TMA/Member_Resources/Telehealth_and_COVID-19 
• TNAAP COVID-19 Telehealth Coding Guidance
• TNAAP COVID-19 Telehealth Guidelines by Payer
• TennCare https://www.tn.gov/tenncare/information-statistics/tenncare-information-about-coronavirus.html 
• TDMHSAS https://www.tn.gov/behavioral-health/covid19.html 
• https://www.tn.gov/content/dam/tn/mentalhealth/documents/TDMHSAS_Email_Providers_3.14.20.pdf 
• https://www.tn.gov/content/dam/tn/mentalhealth/documents/TDMHSAS_Coronavirus_Telehealth_FAQ_3.20.20.pdf 

Provider webinars:

TDH has provided a series of webinars to share clinical and public health updates for front-line clinicians. Recordings of past webinars, and information to join future ones are available here. The TDH site for COVID-19 resources is here. It is updated continuously. 

CDC Clinician Outreach & Communication Activity (COCA) call:

CDC has scheduled another COCA call TODAY (Wednesday, March 25, 2020 from 2:00–3:00 EDT. The presenters will provide a COVID-19 update and discuss strategies for healthcare facilities to optimize personal protective equipment (PPE) supplies such as eye protection, isolation gowns, facemasks, and N95 respirators. More details available here. 

Thank you for all that you do in keeping Tennesseans safe and healthy. 

Tennessee Department of Health 

Download PDF

Austin, Texas – March 13th, 2020

About Sonic Healthcare USA

Sonic Healthcare USA is a subsidiary of Sonic Healthcare Limited, one of the world's largest medical diagnostic companies, providing laboratory services to medical practitioners, hospitals and community health services, with operations in eight countries, on three continents and providing care to over 100 million patients each year. Sonic Healthcare USA is a leading provider of state-of-the-art laboratory services and pathology practices throughout the USA with nine operating divisions and nearly eight thousand US-based employees. Sonic Healthcare USA utilizes a federated business model that emphasizes medical leadership and community-based testing services to provide outstanding quality and service to the doctors and patients that they serve. For more information, visit the Sonic Healthcare website at www.sonichealthcareusa.com.

Austin, Texas – March 6th, 2020

This week, Academic and Commercial Reference Laboratory Executives met with Vice President, Mike Pence and members of the White House's Coronavirus Task Force to collectively discuss diagnostic testing availability for COVID-19. 

Jerry Hussong, MD, MBA, the Chief Executive Officer of Sonic Healthcare USA (Sonic), was among those who met on behalf of the American Clinical Laboratory Association (ACLA) with key government officials, the CDC, and the FDA.  At the meeting, key stakeholders discussed the role of state and local public health and commercial laboratories, hospitals, and academic medical centers to increase access to testing for the Coronavirus.  "Our main goal, as a commercial laboratory, is to ensure those patients in need or at high-risk can access testing. By working together, we can accelerate those efforts with a coordinated and comprehensive approach," said Dr. Hussong.

Dr. Hussong added, "Sonic Healthcare is working with its Medical, Scientific and Operational Leadership to make patient testing available through its network of commercial laboratories in the United States and will follow the FDA guidelines for Emergency Use Authorizations (EUAs)."  The FDA has recently updated its policy, thus providing an expedited pathway for the availability of diagnostics for COVID-19.

Sonic Healthcare will continue to lead and collaborate with colleagues, government officials, and our local medical communities in response to this immediate public health crisis.

Read the ACLA Statement on COVID-19 Testing

About Sonic Healthcare USA

Sonic Healthcare USA is a subsidiary of Sonic Healthcare Limited, one of the world's largest medical diagnostic companies, providing laboratory services to medical practitioners, hospitals and community health services, with operations in eight countries, on three continents and providing care to over 100 million patients each year. Sonic Healthcare USA is a leading provider of state-of-the-art laboratory services and pathology practices throughout the USA with nine operating divisions and nearly eight thousand US-based employees. Sonic Healthcare USA utilizes a federated business model that emphasizes medical leadership and community-based testing services to provide outstanding quality and service to the doctors and patients that they serve. For more information, visit the Sonic Healthcare website at www.sonichealthcareusa.com.

Austin, TX – March 25^th, 2019

American Esoteric Laboratories (AEL), a division of Sonic Healthcare USA (Sonic Healthcare), has announced that it will be a Blue Cross and Blue Shield of Alabama (BCBSAL) Preferred Medical Laboratory Plus Network across the state of Alabama effective April 1, 2019. 

AEL is one of three laboratory service providers that have been awarded this designated status with BCBSAL, providing coverage to more than 1.5 million people in Alabama. AEL provides comprehensive laboratory services in the Mid-South region of the United States and Alabama, including an extensive network of local services. This new expansion of coverage recognizes AEL’s strong medical leadership philosophy that values local continuity of care for patients and provides for comprehensive and responsive laboratory services together with innovative technologies to support physicians and healthcare providers. 

Having AEL as a Preferred Medical Laboratory Plus Network is a significant win for the community, giving covered members additional provider choice and broader access to our local clinical laboratory services and patient service center network. AEL is committed to supporting the Alabama community, and believes in the value of keeping medicine local,” said David Smalley, PhD, President, AEL.

“AEL is ready to provide unparalleled service and capabilities to providers across Alabama. Our unique medical leadership model focuses on an unwavering commitment to patient care and an ongoing alliance with healthcare providers. Our success is predicated on being an integral and collaborative partner with the local medical community, a formula which is deeply embedded into our operating philosophy,” said Jerry Hussong, MD, Sonic Healthcare USA’s Chief Executive Officer.

About Sonic Healthcare USA

Sonic Healthcare USA is a subsidiary of Sonic Healthcare Limited, one of the world's largest medical diagnostics companies, providing laboratory services to medical practitioners, hospitals and community health services, with operations in eight countries, on three continents and providing care to over 100 million patients each year. Sonic Healthcare USA is a leading provider of state of the art laboratory services throughout the USA with nine operating divisions and over seven thousand US-based employees. Sonic Healthcare USA utilizes a federated business model that emphasizes medical leadership and community-based testing services to provide outstanding quality and service to the doctors and patients that they serve. For more information, visit Sonic Healthcare USA.

About Blue Cross and Blue Shield of Alabama

Blue Cross and Blue Shield of Alabama has insured Alabamians for 82 years. Blue Cross offers coverage plans to corporations, individuals and the senior market. For more information about Blue Cross, visit AlabamaBlue.com. Blue Cross and Blue Shield of Alabama is an independent licensee of the Blue Cross and Blue Shield Association. 

Earlier this year CMS started removing Social Security Numbers (SSNs) from all Medicare cards. A new Medicare Beneficiary Identifier (MBI) will replace the SSN-based Health Insurance Claim Number (HICN) on the new Medicare cards for Medicare transactions like billing, eligibility status, and claim status.

CMS currently uses an SSN-based HICN to identify people with Medicare and administer the program, and used the HICN with our business partners.

Under the new system, for each person enrolled in Medicare, CMS will assign and mail a new Medicare card to every member.

The MBI is confidential like the SSN and should be protected as Personally Identifiable Information.

Why are the new Medicare cards important?

The biggest reason for taking the SSN off of Medicare cards is to fight medical identity theft for people with Medicare. By replacing the SSN-based HICN on all Medicare cards, we can better protect the private health care and financial information as well as federal health care benefit and service payments.

It is critical to update your information for patients who have received their new cards! The new Medicare numbers should be updated for all service claims, submitted on orders for services and used in the traditional ways the original Medicare cards would have been used.

How will the MBI look?

The MBI will clearly be different than the HICN and RRB number. It will be:

• 11-characters in length.
• Made up only of numbers and uppercase letters (no special characters); if you use lowercase letters, our system will convert them to uppercase letters.

Each MBI is unique, randomly generated, and the characters are "non-intelligent," which means they don't have any hidden or special meaning. The MBI doesn’t use the letters S, L, O, I, B, and Z to avoid confusion between some letters and numbers (e.g., between “0” and “O”).

Learn more about the MBI formats here and make changes to your systems.

This information and more may be found here and here.

In response to the extensive impact of the Opioid Crisis, many states have implemented various compliance laws that require providers to test patients receiving prescriptions for controlled substances for greater than three days. 

AEL is now offering a partnership program that complies with the testing and documentation requirements of state laws concerning prescribed controlled substances to protect your most valuable assets ... your practice and your patients. 

AEL Toxicology Compliance Partnership Plan Key Components: 

• Consistency Reporting - Toxicology testing is performed at AEL. Results are compared with information provided on the medications being prescribed to the patient. Results clearly indicate if the medications being prescribed are present and at the levels prescribed, as well as the presence of drugs not being prescribed. 
• Monitoring Compliance - Patients are monitored for continual compliance by testing performed at required time intervals to include a percentage of random screening to be established by you. AEL is able to assist you with scheduled screening, random selection of patients for testing, and patient notification. 
• Documentation - AEL generates quarterly trending reports providing data on the consistency performance of the patients in your practice. This data can be readily compared to regional data. This helps to ensure that your patient population is following your guidance for compliance of prescribed medications. 

It is easy to participate in AEL’s Toxicology Compliance Partnership Plan. Once enrolled, you are able to retrieve results and consistency reports utilizing AEL’s web-based portal. Manual test requisitions are also available. AEL provides all of the necessary training for ordering and retrieving reports followed by a completion certificate for participants. At the time of patient enrollment, prescription information should be documented in the medical record and shared with AEL and the appropriate pharmacy. Proper notification regarding compliance expectations and testing requirements will be provided to your patient. Random testing at a designated rate determined by you will also occur. 

The AEL Toxicology Compliance Partnership Plan will assist you in: 

• Meeting all requirements for compliance testing and monitoring. 
• Ensuring that patients are taking medications as prescribed. 
• Providing optimum patient care with positive outcomes. 

Please call your AEL Sales Representative or Customer Service Representative to receive the information booklet for the program. You may also contact the AEL Sales Department at 901.432.8603. We look forward to the opportunity to partner with you to provide excellent patient care.