Client Communications

The Gulf Coast ScientificTM PyloPlus® Urea Breath Test (UBT) for detection of Helicobacter pylori will replace the Meridian/OtsukaTM BreathTek®UBT. The Meridian/OtsukaTM assay has been discontinued by the manufacturer. Validation has determined that:

• The PyloPlus® UBT and BreathTek® UBT use the same methodology, infrared spectrophotometry of CO2 isotopes in breath samples before and after ingestion/metabolism of 75mg of 13C Urea in a citric acid solution.
• The performance characteristics of the PyloPlus®UBT and BreathTek®UBT tests are equivalent.
• As results are qualitative (Positive/Negative), the result reporting and reference interval are unchanged.
• There are minor changes to the collection kit and instructions. Those are given in detail below.
  
  

Effective March 15, 2023, distribution will begin transitioning to PyloPlus®UBT collection kits. Clients may be supplied with the PyloPlus® or BreathTek®UBT collection kits depending on availability of supplies. During this transition, the BreathTek®UBT collection devices will be run on the Meridian/Otsuka platform and incoming PyloPlus®UBT will be run on the Gulf Coast Scientific spectrophotometer platform without delays to testing.

Pediatric Specimens

Gulf Coast Scientific PyloPlus® Urea Breath Test is an FDA-cleared test on adult patients 18 years or older. The Gulf Coast Urea Breath Test is not currently FDA approved for pediatric use. For patients <18 years of age, please perform the pediatric Helicobacte rpylori stool antigen test, test code 18321, by collecting a small sample of stool in a sterile cup.

Gulf Coast ScientificTM PyloriPlus® UBT Procedure

1. Materials provided in each PyloPlus Kit:

1. One pouch of 13C-urea powder
2. One packet of citric acid flavoring
3. Test instructions
4. One Quick Reference Instructions (QRI)
5. Two breath collection bags, one blue bag for the BASELINE sample and one red bag for the POST sample
6. One drinking straw
7. One sample transport bag
   
   

2. Materials needed, but not provided

1. A 15-minute timer
2. Potable water
3. Cup able to measure 100mL of water

3. Patient Preparation

1. The patient should have fasted at least 1 hour before administering the PyloPlus Kit.
2. Antimicrobials/antibiotics, Proton Pump Inhibitors (PPI), Bismuth preparations and Histamine Receptor antagonists (HRA) are also known to suppress H.pylori and may produce false-negative results. Any positive, while on those preparations should be considered a true positive. Upon the advice of their provider, patients should refrain from taking:
   
   i. Antibiotics (e.g., Flagyl, Metronidazole): 2 weeks
   ii. PPI’s (e.g., Nexium, Prevacid, Zegerid and Prilosec): 2 weeks
   iii. Bismuth preparations (e.g., Pepto-Bismol, Kaopectate and Pink Bismuth): 2 weeks
   iv. HRA’s (e.g., Pepcid, Zantac, Axid, Tagamet): 2 days

4. Step-By-Step Procedure

1. Time intervals listed in the following step-by-step procedure are critical.
2. Verify that the patient has been prepared for the test as specified above. If the patient is not appropriately prepared, contact the ordering clinician for further instructions.
3. Open the PyloPlusKit, which should contain all the materials listed in 2.1. Label each breath collection bag to maintain patient identification using a felt tip permanent marker. Include the specimen date and time of collection.
4. Collect the BASELINE breath sample according to the following steps:
   
   i. Pick up the blue breath collection bag.
   ii. Remove the twist-off cap from the mouth piece of the breath collection bag.
   iii. Instruct the patient to: (1) breathe normally; (2) take a deep breath then hold their breath for 10 seconds; (3) partially exhale into the room, before fully exhaling into the mouthpiece of the bag.
   iv. Replace the cap firmly on the mouthpiece of the bag.
   v. NOTE: if the patient has not held their breath for 10 seconds, or does not fill the bag completely, there is a possibility a test result will not be obtained.
   vi. NOTE: The bag is not fully closed if the cap does not click into place. Not fully closing the bag may cause the breath sample to leak, invalidating the result.
   
   
5. Prepare the 13C-urea solution no more than 50 minutes before administering it to the patient. Urea slowly decomposes in water.
   
   i. Pick up the citric acid flavoring packet and tear open. Place contents of flavoring packet into 13C-urea pouch by tearing open the pouch and carefully pouring contents of the flavoring packet into the open 13C-urea pouch.
   ii. Add approximately 100mL drinking water (about 1/3 full) to the 13C-urea pouch.
   iii. Close the Ziplock feature of the 13C-urea pouch securely and shake the mixture for 30 seconds.
   iv. Instruct the patient to drink all of the drug solution with the straw provided directly from the 13C-urea pouch, without stopping. Advise the patient NOT to ‘rinse’ the inside of their mouth with the drug solution before swallowing. Discard the straw after the patient has finished drinking the drug solution.
   
   
6. Set the timer for 15 minutes. The patient should sit quietly and should not eat, drink, or smoke during the 15-minute interval.
   
   
7. After 15 minutes have elapsed, pick up the red (pink) breath collection bag. Collect the POST-SAMPLE breath sample according to the instructions above
   
   

References

PyloPlus® UBT Kit for PyloPlus® UBT System Breath Test for Detection of H. pylori. Package Insert. Gulf Coast Scientific TM. REV_B

Effective April 10, 2023 East Side Clinical Laboratory will offer antimicrobial susceptibility testing on positive Neisseria Gonorrhoeae cultures.

Principle

Neisseria gonorrhoeae is a sexually transmitted organism usually recovered from genital (vaginal, cervical, urethral, prostate, semen, etc.) sources. It can, however, be isolated from various other mucosal body sites (eye, throat, anal, synovial fluid). All genital cultures automatically incorporate a screen for N. gonorrhoeae in the culture. If the clinician suspects an infection from N. gonorrhoeae in a non-genital site, a gonorrhoeae culture should be performed. A gonorrhoeae culture is also performed when a clinician specifically orders a culture exclusively for N. gonorrhoeae from a genital site.

Specimen Collection, Transport & Handling
Specimens should be collected utilizing an eSwab. Acceptable Sources:

1. Endocervical
No use of lubricant during collection. Wipe cervix clean of mucus. Rotate swab, obtain exudate from endocervical glands. If no exudate, insert into canal and rotate swab.

2. Vaginal (not optimal)
Insert swab into vagina. Collect discharge or secretions from mucosa in vaginal canal.

3. Urethral

• Collect 1-2 hrs or more after urination.
• Female: stimulate discharge by massaging urethra against pubic symphysis through vagina. Collect discharge with swab. If discharge cannot be collected, wash external urethra with Betadine soap and rinse with water. Insert a urogenital swab, rotate. Leave if 1-2 seconds, and withdraw.
• Male: insert thin urogenital swab 2-4 cm into endourethra, rotate. Leave for 1-2 seconds, and withdraw.

4. Epididymis

Aspirate material, and eject into sterile container.

5. Pharyngeal

Push down tongue gently with a depressor. Extended swab between tonsillar pillars and behind uvula. Avoid touch surfaces of mouth. Sweep back and forth across posterior pharynx.

6. Rectal (free of stool)

Pass tip of swab approximately 2 cm beyond anal sphincter. Rotate, and withdraw.

7. Eye

• Collect purulent material on a swab.
• All eye cultures from newborns [up to 1 month old] incorporate are to be screened for gonorrhoeae.

8. Synovial fluid

Ordering Information:

Specimen Requirements: ESWAB

Transport Temperature: Room Temperature

Stability: 24 hours (For best results submission within less than 12 hours recommended)

Expected time to result: 3 days

Unsuitable Specimens: Frozen specimens

CPT Codes: 87081 (additional CPT codes will apply if microbial testing is needed)

A panel of antibiotics recommended by the Clinical Laboratory Standards Institute (CLSI) includes:

• Cefepime
• Cefixime
• Cefotaxime
• Ceftriaxone
• Ciprofloxacin
• Penicillin
• Tetracycline

***Please indicate source on collection device and on requisition***

Please contact your East Side Clinical Laboratory Sales Representative with any questions.

Effective April 30, 2023, East Side Clinical Laboratory will discontinue accepting throat swabs for Influenza A + B testing. Beginning May 1, 2023, testing for Influenza A + B will only be performed utilizing a nasal or nasopharyngeal collection. By discontinuing throat collection, we can utilize a nucleic acid amplification test (NAAT) which detects up to 42% more true positives when compared to a rapid antigen test (RADT), providing the best quality testing for patients.

Please contact your East Side Clinical Laboratory representative with any questions.

Group A strep:

• Specimen types:
  - Throat
• Container types:
  - Dry culturette swab (CANNOT be combined with a second test)
  - E-swab (can be combined with other tests)

Flu:

• Specimen types:
  - Nasopharyngeal (preferred)
  - Nasal
• Container types:
  - Dry culturette swab (CANNOT be combined with a second test)
  - E-swab (can be combined with other tests)
  - VTM (can be combined with other tests)

COVID:

• Specimen types:
  - Nasopharyngeal (preferred)
  - Nasal
  - Oropharyngeal
• Container types:
  - VTM (preferred)
  - E-swab

MULTIPLEX (FLU, RSV & SARS-CoV-2):

• Specimen types:
  - Nasopharyngeal (preferred)
  - Nasal
• Container types:
  - VTM

COVID SWABS ARE DISCARDED ONCE RESULTS ARE FINALIZED.

Other respiratory testing CANNOT be added on later once PCR testing has occurred

Effective July 25, 2022, East Side Clinical Laboratory is pleased to announce the availability of Monkeypox Virus by PCR testing.

Monkeypox Virus PCR test methodology is real-time PCR utilizing the CDC Non-variola Orthopoxvirus Real-Time PCR Primer and Probe Set. The assay detects non-variola Orthopoxvirus DNA in clinical specimens. Although this assay does not differentiate monkeypox virus from other Orthopoxvirus including vaccinia, cowpox, camelpox, ectromelia or gerbilpox virus a positive result with this assay in the United States is most likely due to monkeypox virus; however, potential exposure to other Orthopoxviruses should be considered.

The test results are intended to be utilized in conjunction with clinical presentation, epidemiological data, other diagnostic test results, and vaccination and exposure history. As monkeypox virus infections can present with rashes/lesions similar to that of varicella zoster virus, herpes simplex virus, and other sexually transmitted infections, consider testing for other pathogens as clinically indicated.

Test Code: 5900

Ordering recommendation: For detection of non-variola Orthopoxvirus, including monkeypox virus, DNA in clinical specimens.

Specimen Requirements: Double-Dry swab (polyester, rayon, or dacron) collection from skin lesion. Two swabs should be submitted to ensure adequate material is sampled. Break off or cut the tip of each swab into a sterile tube or container. Each swab should be placed in a separate tube or container. Freezing sample is strongly recommended.

Unsuitable specimen: Single swab. Cotton swab. Swabs with wooden or wire shafts. Swabs in media designed for preservation and/or transport.

Transport temperature: Frozen

Stability: 7 days refrigerated; 1 month frozen.

CPT codes: 87593

For questions, contact your East Side Clinical Laboratory Customer Service Representative.

Laboratory Testing Guidelines

• Swab or brush the pustule/lesion vigorously with two separate sterile swabs.
• Collect at least two swabs from the same lesion.
• If possible, sample paired specimens from multiple lesions on different parts of the body and with differing appearances. CDC suggests 2-3 lesions total.
• Use a sterile nylon, polyester, or dacron swab with a plastic or thin aluminum shaft.
• Do not use other types of swabs. Do NOT use cotton swabs.
• Break off or cut the tip of each swab into a sterile tube or container.
• Place each swab into a separate dry sterile tube or container and ensure that the tube/container is tightly sealed and leak proof.
• Do NOT add transport media to specimen.
• Multiple specimens collected on a single patient should be submitted separately.
• Each individual specimen submitted for Monkeypox virus testing should be accompanied by its own separate requisition and transported in its own sealed bag.

• Refrigerate (2–8°C) or freeze (-20°C or lower) specimens within an hour after collection.

• Freezing is strongly recommended.

• Ship frozen (preferred) or refrigerated (acceptable). To maintain optimum specimen viability, transport the specimen to the laboratory as soon as possible.

Monkeypox: Interim Guidance from the CDC for Healthcare Providers

Clinical features

• Caused by Monkeypox virus (MPXV)
  • Two clades: Central African (CAC) & West African (WAC). WAC is less virulent and is the predominant clade circulating in the US.
  • Orthopox genus, which includes variola/smallpox, cowpox.  MPXV is NOT related to varicella/chickenpox/shingles.
  • Demonstrates extraordinary resistance to drying, heat, and pH, which leads to environmental persistence. Materials with MPX virus may remain infectious for months to years.
• Incubation period - 6 -13 days, up to 21 days.
• Signs/Symptoms
  • Fever, headache, swollen lymph nodes (which may differentiate it from smallpox), respiratory symptoms, GI symptoms, including diarrhea.
  • Characteristic Rash - See photos and complete description, below
    • May look like pimple or blister
    • Appears on face, inside of mouth, genitals, and other body parts
• Labs – 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.

  • Possible for up to several weeks.

• Prevention

  • Avoid contact, good hygiene, PPE

  • Vaccine – JYNNEOS/Imvanex: inactive virus, FDA approved

• Complications – Bacterial infection, sepsis, dehydration, diarrhea, encephalitis, death.

• Treatment – None, but smallpox anti-viral (TPOXX/tecovirimat) may be indicated for 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 through an online website, digital application (“app”), or social event (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 sometimes 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.

The outbreak caused by MPXV is rapidly evolving, and we will continue to monitor the situation and update you as new information becomes available.

Extensive additional information on monkeypox can be found at the CDC’s website.

References:

Collection, Storage, and Shipment of Specimens for Monkeypox Diagnosis. CDC.
https://www.cdc.gov/poxvirus/monkeypox/clinicians/prep-collection-specimens.html

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

U.S. Monkeypox Outbreak 2022: Situation Summary. Centers for Disease Control and Prevention website. Accessed June 2022.

US Monkeypox outbreak 2022. CDC’s 2022 U.S. Map & Case Count.
https://www.cdc.gov/poxvirus/monkeypox/response/2022/us-map.html

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

KD Reed, et al., The detection of monkeypox in humans in the Western Hemisphere. N Engl J Med. 2004. 350, 342–350. https://pubmed.ncbi.nlm.nih.gov/14736926/

Printable Version

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 East Side Clinical Laboratory:

• All high-throughput SARS-CoV-2 molecular assays performed at East Side Clinical Laboratory 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.

NEW SARS-CoV-2, Influenza A+B, RSV Panels

Changes in Estimated Glomerular Filtration Rate (eGFR) Calculation: Removal of Race-Based Adjustment

Effective October 13, ESCL will begin performing RSV/hMPV by NAAT.

The Solana RSV + hMPV Assay is a qualitative in vitro diagnostic test for the detection and differentiation of RSV and hMPV viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of RSV and hMPV viral infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub‐lineages of hMPV.

RSV: Human respiratory syncytial virus (RSV) is a negative single‐stranded RNA virus of the family Paramyxoviridae. RSV is the major cause of lower respiratory tract infection and hospital visits during infancy and childhood.

hMPV: Human metapneumovirus (hMPV) is a negative single‐stranded RNA virus of the family Paramyxoviridae first isolated in 2001 in the Netherlands.  hMPV may be the second most common cause (after RSV) of lower respiratory infection in young children. Compared with RSV, infection with hMPV tends to occur in slightly older children and produce disease that is less severe. Co‐infection with both viruses can occur and is generally associated with more severe disease.

Test Code: 11720
Specimen Requirements: VIRUS TRANSPORT MEDIA OR EQUIVALENT.
ESWABs and Dacron or Rayon swabs are also acceptable. 
Transport temperature: Refrigerated
Stability: VTM: 6 days refrigerated; eSwab 48 hours refrigerated
Result Interpretation: Negative
CPT code: 87634; 87798

For questions contact your East Side Clinical Laboratory representative

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

jhussong@sonichealthcareusa.com

512.531.2216

Effective February 8, 2021, ESCL is announcing availability of a Spike Antibody test for COVID-19. This immunoassay detects high affinity antibodies against spike (S) protein receptor binding domain (RBD). The assay is intended as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

This assay also identifies the immune response induced by vaccines targeting the SARS-CoV-2 Spike (S) protein receptor binding domain (RBD).

Test Code: 11359

Traceability: Internal Roche standard for anti-SARS-CoV-2 S consisting of monoclonal antibodies.

Specimen Requirements: Serum from an SST tube

Transport temperature: Refrigerated

Stability: 7 days refrigerated

Result Interpretation: <0.8 U/ml = negative, >=0.8 U/ml = positive

Positive Percent Agreement (PPA): 96.6% in samples >14 days post-PCR positive.

Negative Percent Agreement (NPA): 99.98% in potentially cross-reactive samples.

CPT code: 86769                      

For questions contact your East Side Clinical Laboratory representative

10 Risho Ave East Providence RI 02914           
www.esclab.com        
Issue Date: February 5, 2021

View the Requisition

Dear Providers,

East Side Clinical Laboratory is taking further steps to prevent the spread of COVID-19. Minimizing the risk of transmission among staff and between staff and patients as well as protecting people who are at higher risk for adverse health complications is of utmost concern to us.

In light of these concerns, we have implemented the following change to our practice to mitigate the impact of COVID -19:

We will not be providing nasal/throat swab collections (e.g. for influenza, group A strep, throat culture testing) at our Patient Service Centers or Independent Physician Offices during the ongoing COVID19 pandemic.

Note: Patients visiting a patient service center must wear a mask or face covering and must not be experiencing COVID -19 symptoms. Patients may not take their mask or face covering off while in our Patient Service Centers. We do not offer swab collection for COVID-19 testing.

Our mission is to provide the highest quality laboratory testing to our patients and clinical providers to aid in the diagnosis and treatment of disease.

For the safety of our patients and our staff, we cannot perform any specimen collections that would require patients to remove their masks or face coverings.

Thank you,

Walther M. Pfeifer, MD, FCAP Laboratory Director East Side Clinical Laboratory

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.

Lyme Modified Two-Tier Test (MTTT)

Effective Monday, August 17, 2020, East Side Clinical Laboratory will offer testing for Lyme disease with the Modified Two-Tier Testing (MTTT) methodology. It is intended to be used in symptomatic patients suspected of having Lyme disease.

MTTT is a FDA cleared sensitive and specific alternative to Standard Two-Tier Testing (STTT) for Lyme disease. Unlike the STTT, the MTTT utilizes ELISA in both the first and second tiers, and does not utilize immunoblotting (Western Blot or Line Blot methods), detecting more acute Lyme disease cases compared with the traditional testing methods.

The first-tier is an ELISA which screens for B.burgdorferi VlsE/pepC10 IgG/IgM antibodies, with positives reflexing to the second tier.

The second-tier is an ELISA utilizing B.burgdorferi WCS (Whole Cell Sonicate antigens), comprised of specific assays for IgG and IgM, in which all results are individually reported with an Index Value, followed by comments and interpretations.

References:  

• Updated CDC recommendation for Serologic Diagnosis of Lyme Disease can be found in MMWR/August 16,2019/Vol. 68/No.32 703 or at
• https:www.cdc.gov/mmwr/volumes/68/wr/mm6832a4.htm?s_cid=6832a4_w

Test Code: 25851

Specimen Requirements: Serum from SST or plain red top tube

Transport Temperature: Refrigerated

Stability: 10 days refrigerated

CPT codes: 88618-If reflexed, add 86617(x2)

Please contact your ESCL account representative with any questions.

Effective July 1, 2020, East Side Clinical Laboratory has discontinued performing Acetest testing for serum and urine ketones due to discontinuation of reagent by the manufacturer and has been replaced with quantitative serum B-Hydroxybutyrate (6942).

The presence and degree of ketosis can be determined by measuring levels of Beta-hydroxybutyrate, which is the ketoacid present in the greatest amount in serum, accounting for 75% of the ketone bodies. During periods of ketosis, the relative percentage of Beta-hydroxybutyrate increases even more over the other two ketoacids (acetoacetate and acetone) and has been shown to be a better index of ketoacidosis including the detection of sub-clinical ketosis.

βHB levels have also been shown to be useful for assessing patients that may require additional insulin therapy following IV insulin drips for DKA. βHB may be helpful for establishing endpoints for IV therapy.

Discontinued tests with order codes:

Replacement test with order codes:

If you have any questions, please call East Side Clinical Laboratory at 800-455-8440

Or contact your East Side Clinical Laboratory representative.

Thank you for allowing us to continue to provide the highest quality laboratory testing services to you and your patients.

Effective April 30, 2020, East Side Clinical Laboratory (ESCL) will update reference ranges for the Complete Blood Count (CBC).

The new adult reference ranges reflect a Sonic Healthcare USA consensus which align with those of other large reference laboratories and hospital systems. The pediatric reference ranges align with those published by the American Association for Clinical Chemistry [Pediatric Reference Intervals, 7^th ed. (2011)] and American Society for Clinical Pathology [Practical Diagnosis of Hematologic Disorders, 4^th ed. (2006)].  The new reference ranges are not expected to significantly shift the percentage of patients flagged as having abnormal results; however, a shift of up to 5% in the number of patients with abnormal results for selected components such as hemoglobin may be seen.

Over the next 3 months, ESCL will make additional changes to CBC reporting that are aligned with accepted laboratory standards.  These include the following changes (implemented in the order listed):

• Reporting absolute WBC counts (absolute neutrophil count, absolute lymphocyte count, etc.) with respective reference ranges.

Under most circumstances, clinically relevant WBC elevations and declines are defined by absolute counts, not by relative percentages. Current recommendations for the College of American Pathologists (CAP) and the Clinical and Laboratory Standards Institute (CLSI) recommend that absolute counts be the preferred method for reporting the WBC differential.

• Discontinuing reporting of reference ranges for relative (%) WBC differential counts as they are not the recommended method of reporting.

For questions related to CBC reference range changes, please contact your ESCL account representative.

March 16, 2020

East Side Clinical Laboratory, Inc. is pleased to announce that testing for SARS-Cov-2/COVID-19 is available as of March 10th, 2020.

Due to strong market demand and limited supply nationwide, priorities will be given to high risk patients in accordance to CDC guidelines and endemic regions and clusters.

Test Information:
Test Code: COVIDHR - 17100
Test Name: SARS-COV-2 (COVID-19) BY RT-PCR, HIGH RISK

Ordering Recommendations:
Ordering provider to determine patient risk level based on CDC Guidelines and clinical judgement.

• Sonic has created an orderable code to triage patients, prioritize testing and coordinate with public health authorities:
     o SARS-COV-2 (COVID-19) - High Risk: Patients who are symptomatic, exhibiting respiratory illness (cough, fever, and dyspnea) AND have traveled to a COVID-19 endemic area, have been in close contact with a known COVID-19 patient or are otherwise considered High Risk exposure from an epidemiological perspective.
• Criteria to Guide Evaluation of PUI (Persons Under Investigation) for COVID-19: The CDC currently states Clinicians should use their judgment to determine if a patient has signs and symptoms compatible with COVID-19 and whether the patient should be tested. Decisions on which patients receive testing should be based on the local epidemiology of COVID-19, as well as the clinical course of illness.
• Clinicians are strongly encouraged to test for other causes of respiratory illness, including infections such as influenza.

• In accordance with public health guidance, clinicians should prioritize testing to following groups:
  1. Hospitalized patients who have signs and symptoms compatible with COVID-19 in order to inform decisions related to infection control.
  2. Other symptomatic individuals, such as older adults and individuals with chronic medical conditions and/or an immunocompromised state that may put them at higher risk for poor outcomes (e.g., diabetes, heart disease, receiving immunosuppressive medications, chronic lung disease, chronic kidney disease).
  3. Any person, including healthcare personnel, who within 14 days of symptom onset had close contact with a suspected or laboratory-confirmed COVID-19 patient, or who had a history of travel from affected geographic areas.

Specimen Requirements:
Sample Type:
• Upper Respiratory Tract: Nasopharyngeal Swab
Container Type: *Prefer dedicated collection device
• Nasopharyngeal swab: Viral or Universal Transport Media (VTM, UTM, VCM, UTM-RT, or M4) with Swab(s).

Must be ordered independent of other testing and include CDC PUI Form.

Handling Instructions:
Nasopharyngeal Swab: Insert a swab into the nostril parallel to the palate. Leave the swab in place for a few seconds to absorb secretions. Place swab immediately into sterile tube containing 2- 3 mL of viral transport media.
Transport: Critical Refrigerated
Unsuitable Specimens: Ambient specimens. Swabs not in viral transport media. Calcium alginate swabs. Swabs with wooden shafts. eSwab, any device refrigerated more than 72 hours post collection.

Testing Capacity:
Testing is performed seven days a week.
• Expected TAT is 1-3 days.
   o TAT may vary with changes in capacity and market demands.

CPT Codes: U0001 – Real-Time Polymerase Chain Reaction (RT-PCR)
LOINC Codes: SARS-CoV-2 Interpretation (94306-8), Naso and Oro SARS-CoV-2 (94316-7), Nasopharyngeal SARS-CoV-2 (94316-7)

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Austin, Texas – March 13th, 2020

Sonic Healthcare USA has worked closely with its scientific partners and medical and operational leadership to bring up testing to ensure timely availability for patients in all geographies served by our laboratories. "We are closely monitoring capacity and are coordinating with our clinical laboratories to distribute testing that mitigates high demands from endemic regions and clusters in the United States," said Jerry Hussong, MD, MBA, the Chief Executive Officer of Sonic Healthcare USA.

Sonic has taken comprehensive measures to expand testing capacity, while maintaining high quality testing and meeting required turnaround times. As a result, Sonic is bringing up multiple testing platforms and methodologies.

Dr. Hussong added, "In response to this public health emergency, Sonic Healthcare USA pledges to do its part and is actively monitoring the situation. Our commitment is to ensure testing is available as this pandemic evolves." The well-being of our patients and employees is our highest priority, and we continue to be committed to the medical communities we serve.

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.

Issued December 10, 2019: The previous protocol for urine cultures being processed by East Side Clinical Laboratory was to re-incubate for an additional 24 hours if no growth was observed initially on day 1.  Current understanding of urinary pathogens has now rendered this re-incubation unnecessary.  Most causative agents of UTI’s can be identified by routine urine culture, which has been published as not benefitting from 48 hours of incubation.  East Side Clinical Laboratory will continue to re-incubate cultures from catheterized specimens, children 10 years of age or younger, or if a clinician suspects a fastidious pathogen that requires additional incubation.

Our goal at East Side Clinical Laboratory is to ensure that patients receive results in a timely manner without compromising testing.  By reporting urine cultures in 24 hours, we ensure results are communicated timely to guide treatment decisions.  Additional incubation on routine urine cultures will not be performed unless specifically requested.

For more information regarding the change in protocol, please contact your ESCL representative or the ESCL Microbiology Supervisor (Kelly Messier, 401-455-8427). 

Thank you for allowing us to continue to provide the highest quality laboratory testing services to you and your patients.

REFERENCES:

• Wilson ML, Gaido L.  Laboratory Diagnosis of Urinary Tract Infections in Adult Patients. Clinical Infectious Diseases. 15 Apr 2004,38(8):1150-1158. DOI 10.1086/383029.
• Shoskes D. The American Urological Association Educational Review Manual in Urology. Third Edition. Chapter 23: Urinary Tract Infections. 2011.
• Ulett KB, Benjamin Jr WH, Zhuo F, et al. Diversity of Group B Streptococcus Serotypes Causing Urinary Tract Infection in Adults. ASM Journal of Clinical Microbiology. July 2009,47(7):2055-2060. DOI 10.1128/JCM.00154-09

• Patients on high dose supplements of biotin (minimum 5-10 mg/day), such as hair/nail/ skin supplements, should refrain from taking them in the 24 hours prior to laboratory test.
• Supplements may or may not prominently indicate they contain biotin.
• Patients taking prescribed megadose regimens (>150 mg biotin, usually prescribed for multiple sclerosis) should refrain from taking the supplements for 2-3 days prior to laboratory testing, after consulting with their physician.

THE LEVEL OF BIOTIN TYPICALLY FOUND IN MULTIVITAMIN TABLETS DOES NOT INTERFERE WITH LABORATORY TESTING. *Patients and physicians should review any lab test result that does not match the clinical presentation and consider if biotin interference is present.

Effective November 4, 2019, East Side Clinical Laboratory will no longer offer Helicobacter pylori (H. pylori) serology testing based upon changes in H. pylori testing guidelines of the American College of Gastroenterology and the American Gastroenterology Association. The discontinued antibody tests below will be inactivated in our compendium and will not be orderable. Serological antibody results have poor positive predictive value (PPV) and are no longer considered clinically useful. The alternative noninvasive testing methods demonstrate higher clinical utility, sensitivity, and specificity.

A positive H. pylori IgG, IgA, or IgM result cannot be used to predict the presence of active disease. Since antibodies to H. pylori remain detectable for years following resolution of infection, serologic testing cannot be used to distinguish active from past infection or to document eradication of the organism following successful treatment.

Many insurance companies are no longer reimbursing patients for whom H. pylori serologic testing was performed, as they consider such testing “not medically necessary”. As an alternative, providers are encouraged to collect samples for Urea Breath Test or Stool Antigen Test. Both assays are FDA cleared for use to detect H. pylori infection, and as a test of eradication. Clients should order collection kits as needed with instructions for use.

Discontinued Test With Order Codes:

Recommended Tests With Order Codes

If you have any questions please call East Side Clinical Laboratory at 800.455.8440 or contact your East Side Clinical Laboratory representative.

Effective September 15, 2019 East Side Clinical Laboratories will offer a new collection device, the APTIMA Multitest Orange Swab for Bacterial Vaginosis, Candida, Gonorrhea (GC), Chlamydia (CT) and Trichomonas (Trich) Amplification Testing. This swab can be used in place of the white label APTIMA swab (with the exception of endocervical and male urethral samples).

APTIMA Multitest Orange Swab Utilization

Specimen Information

Effective January 1, 2019, East Side Clinical Laboratory (ESCL) will discontinue offering combined testing for high and low risk Human Papillomavirus (HPV). Low Risk HPV will no longer be performed. This change is due to the implementation of newer analytic methods and testing algorithms.

The following tests/order codes will be deleted with this update:

HPV low risk will be removed from the following test codes with this update:

As an alternative, ESCL offers Roche high risk HPV testing with genotyping information. Amongst high risk HPV infections, genotypes 16 and 18 are most strongly associated with cervical cancer and severe Dysplasia/CIN3.

For high risk testing with genotype information, we offer the following:

High risk HPV:

• Co-testing is endorsed by the American Congress of Obstetricians and Gynecologists (ACOG) and other authorities for woman 30-65 years of age

   

• Algorithms adopted by the American Society for Colposcopy and Cervical Pathology (ASCCP) recommend high risk HPV genotyping for types 16 or 18 as an immediate alternative to a return visit for a  pelvic examination and repeat co-testing for those patients found to be high risk HPV positive and PAP negative(see algorithms at www.asccp.org/Guidelines)
• Genotyping for 16 and 18 can be used to refine management of women 21-29 years of age in certain clinical scenarios

For questions related to HPV testing options, please contact your ESCL account representative.

East Side Clinical Laboratory is pleased to announce the introduction of the QuantiFERON-TB Gold Plus assay which offers optimized analysis with tuberculosis (TB)-specific antigens that elicit both CD4+ and CD8+ T-cell responses. The new 4-tube collection set enables a more comprehensive assessment of cell-mediated immune responses to TB infection

Clients should begin to order QFT - 4 tube kits but may continue to send the 3-tube collection kits until January 1, 2019 when the 3-tube version will be discontinued.

The 4-tube assay requires the same pre-analytical processing steps as the current 3 tube QuantiFERON Gold assay. Immediately after filling the tubes with 1ml blood, shake 10 times just firmly enough to coat the inner surface of the tubes without disrupting the gel.

Please use test code 9884 when ordering the 4-tube assay. Tubes should remain at room temperature for same day transport to ESCL

For questions related to TB GOLD Plus testing, please contact your ESCL account representative.

Thank you for choosing East Side Clinical Laboratory