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:
|4138||H. pylori IgG, IgA, IgM Antibodies|
|4091||H. pylori IgG Antibody|
|4140||H. pylori IgA Antibody|
|4141||H. pylori IgM Antibody|
Recommended Tests With Order Codes
|1832||H. pylori Antigen, Feces|
|5173||H. pylori Breath Test|
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
|Clinician Collected||ESCL Test Code|
|GC/CT Trich Vaginal||5780|
|Bacterial Vaginosis Panel||15700|
|Bacterial Vaginosis, Candida, Trichomonas||16201|
|Bacterial Vaginosis, Chlamydia/GC||16202|
|Bacterial Vaginosis, Candida, Chlamydia/GC, Trichomonas||16203|
|Candida by PCR||15800|
|HSV I/II, VZV by PCR||13322|
|HSV I/II by PCR||5367|
|Turn Around Time||Analytic time 2-5 days after receipt|
|Transportation||Room temperature (15-25°C) or refrigerated (2-8°C)|
|Stability||After inoculation, sample stable in collection device for 60 days|
|Rejection Criteria||Empty collection devices, unlabeled samples and leaking samples|
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:
|Test Name||Test Code|
|PAP and HPV (high and low risk)||4176|
|PAP with GC/Chlamydia||4178|
|HPV (high and low risk)||4196|
|PAP smear with HPV Reflex for Ascus/Agus||4182|
HPV low risk will be removed from the following test codes with this update:
|Test Name||Test Code|
|PAP with HPV reflex Ascus/Agus and GC Chlamydia||4184|
|PAP with HPV reflex for all abnormalities and GC/Chlamydia||4193|
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:
|HPV Genotypes 16 and 18||9848|
|HPV Genotypes 16 and 18/45||15670|
|HPV High Risk Genotype 16/18 with reflex PAP||10075|
|HPV mRNA E6/E7||4174|
|HPV mRNA Genotpyes 16, 18/45||16565|
|HPV mRNA with reflex to Genotypes 16, 18/45||16564|
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
|Value stated and less than||Value stated and greater than|
CSF (Cerebral Spinal Fluid)
Malaria/Babesia on peripheral smear
Call/page all positive or suspicious results
Call/page if abnormal
NEW TEST ANNOUNCEMENT
Rapid Flu A + B Testing by Molecular Isothermal Nucleic Acid Amplification
Influenza is a viral infection that affects mainly the nose, throat, bronchi and, occasionally, lungs. Seasonal influenza viruses circulate worldwide and can affect anybody in any age group. The viruses cause annual epidemics that peak during winter in temperate regions. Seasonal influenza is a serious public health problem that causes severe illness and death in high risk populations
Rapid and accurate diagnosis of viral infection is critical to reducing the disease burden of influenza and its social and economic consequences. Since taking antiviral drugs within the first 48 hours after first symptoms appear may reduce the length of illness and help prevent more-serious problems with influenza, it is important to get accurate test results early.
East Side Clinical Laboratory will begin offering a molecular nucleic acid amplification method for rapid testing of Influenza A and B.
- This molecular method increases the likelihood of detection of Flu A + B:
- Non-molecular methods have lower sensitivity and relies on the quality of the sample collected
- Molecular methods have increased sensitivity for more reliable detection of infection
- Molecular amplification increases the likelihood of detection, even in suboptimal collections
- Molecular test looks for nucleic acid-DNA or RNA to identify molecule while lateral flow uses antibody/antigen response
- Highly accurate results in 15 minutes from start to finish of testing
- More accurate testing = better patient care
PLEASE NOTE THAT ACCEPTABLE SPECIMEN REQUIREMENTS FOR THIS TEST ARE:
Nasal eSwab from just inside the nares
Nasopharyngeal swab (which can be supplied by ESCL upon request. These swabs are not normally supplied and might need to be specially ordered resulting in longer turn around time)
Throat swabs ARE NOT an acceptable specimen for molecular flu testing
Please contact your East Side Clinical Laboratory service representative for more information
Immunochemical Fecal Occult Blood
Effective July 19, 2017 East Side Clinical Laboratory has introduced iFOBT as part of its routine testing for screening colorectal cancer. As an immunological test for fecal hemoglobin, iFOBT is more accurate than the conventional guaiac methods. This test does not show significant cross-reactivity against dietary substances and does not require special restrictions prior to testing.
The test is recommended for:
- Routine physical examination
- Monitoring bleeding in patients
- Screening colorectal carcinoma
Due to improved sensitivity and specificity of this method, only one sample collection from a single bowel movement is required for testing.
Patients can submit their specimen by mail by following the instructions for the iFOB collection device, or they may collect the sample in sterile container and drop off at any of our patient service centers.
Comparison of iFOB vs Chemical Guaiac based method
|iFOBT||Guaiac Based Method|
|Immunoassay test using antibodies to detect human hemoglobin protein in stool||Chemical Test|
|Highly specific for human hemoglobin||Potential fals positives from food and medications|
|Detects as low as 50ng/mL human specific hemoglobin||Detects 90,000ng/mL or higher of non-specific hemoglobin|
|No dietary or drug restrictions or preparations||Diet and drugs can interfere ; seveal days of preparation required|
|Only one sample is required||Three samples are required|
|72-hour Sample Stability2||NT-proBNP is stable in EDTA plasma for three days at room temperature or longer at 4°C|
|Practical Considerations for Use of Natriuretic Peptide Testing3|
In patients presenting with acute dyspnea:
In patients admitted to hospital with decompensated heart failure:
|Natriuretic Peptide Levels Across Stages of Heart Failure4||BNP and NT-proBNP values (median, 25th – 75th percentile) in patients classified according to AHA/ACC classification|
|Prognostic Value of Changes in NT-proBNP in Patients with Chronic Heart Failure5||Rising peptide levels predict a higher likelihood of HF-related complications and death, while falling levels are associated with decreased risk. Trend information of peptide levels over time provide a more comprehensive picture of patient risk than single tests.|
|References||1 proBNP II Package Insert (2015-02, V 8.0) 2 Yeo KT et al. Multi-center evaluation of the Roche NT-proBNP assay and comparison to the Biosite Triage BNP assay. Clinica Chimica Acta. 2003; 338:107-115.. 3 Maisel A et al. State of the art: Using natriuretic peptide levels in clinical practice. European Journal of Heart Failure. 2008;10:824-839. 4 Emdin M, et al. Comparison of BNP and NT-proBNP for early diagnosis of heart failure. Clin. Chem. 2007; 53:1289-1297. 5 Masson, S., et al.: Prognostic Value of Changes in N-Terminal ProBNP in Val-Heft (Valsartan Heart Failure Trial). JACC. 2008;52:997-1003.|
Enter body of accordion
BNP has been switched to NT-ProBNP
It is important to note that the numerical results and reference ranges for previous BNP and NT ProBNP are not interchangeable.
Pro B Natriuretic Peptide (NT-ProBNP) Blood Level: Test Code 5285
Replacing: 9401 BNP (Brain Natriuretic Peptide)
Specimen Requirements: 1 ml Serum from SST. Refrigerate. Stable 6 days refrigerated.
New Interpretive Ranges:
|Age||Heart Failure Likely|
|<50 years||≥ 450 pg/mL|
|50 -75 years||≥ 900 pg/mL|
|>75 years||≥ 1800 pg/mL|
|If NT-ProBNP is less than 300pg/mL, heart failure is unlikely for all ages.|
- Proven to be better of early heart failure in multiple studies
- Zero percent cross reaction with Natrecor (recombinant BNP) allowing the usage of NTproBNP to observe patient response while infusion is in progress.
- Inactive adn stable part of the natriuretic molecule; therefore, present in bloodstream longer (half-life of 2 hours) versus BNP half-life of 18 minutes.
- In-vitro strability of 6 days, refrigerated/
- Values for NO-ProBNP are generally 8 to 10 times higher than BNP.
Please refer to www.esclab.com for additional information.
Dear ESCL Client:
Effective May 1, 2017, be East Side Clinical Laboratory will offer high sensitive cardiac Troponin T as a replacement for current Troponin I testing.
High sensitivity (hs) cardiac Troponin T (cTnT) has been validated on the Roche cobas® platform as an Electrochemiluminescent Immunoassay (ECLIA) and orders will be migrated to Troponin T beginning May 1, 2017
Gimenez MR, et. al. measured the diagnostic and prognostic accuracy of cTnT and cTnI using clinically available high sensitivity assays (Roche hs-cTnT vs. Abbott hs-cTnI). Patients at presentation, early presenters (< 3 hours since onset of chest pain), late presenters and prognostic accuracy were evaluated.
The findings demonstrated:
- Diagnosis at presentation performance was similar for both hs-cTnT and hs-cTnI.
- Diagnosis of early presenters showed slightly higher accuracy for hs-cTnI.
- Diagnosis of late presenters showed superior performance for hs-TnT.
- Prognostic accuracy for all-cause mortality was significantly higher for hs-cTnT.
Diagnostic performance of high-sensitivity cardiac troponins I and T. Receiver-operation-characteristic curves show the diagnostic accuracy of high-sensitivity cardiac troponins I and T for non-ST segment myocardial infarction at presentation to the emergency department with acute chest pain in the overall cohort (A) and in patients with a chest pain onset with 3hrs (B)
Diagnostic performance of high-sensitivity cardiac troponin T and I within time. Receiver-operation-characteristic curves displaying the diagnostic accuracy for non-ST segment myocardial infarction of serial sampling of high-sensitivity cardiac troponin I vs. high-sensitivity cardiac troponin T. Prognostic performance of high-sensitivity cardiac troponin T and I. Receiver-operation-characteristic curves displaying the prognostic accuracy for all-cause mortality during the 24-month follow-up of high-sensitivity cardiac troponin I and high sensitivity cardiac troponin T.
Diagnostic performance of high-sensitivity cardiac troponin T and I within time. Receiver-operation-characteristic curves displaying the diagnostic accuracy for non-ST segment myocardial infarction of serial sampling of high-sensitivity cardiac troponin I vs. high-sensitivity cardiac troponin T.
Prognostic performance of high-sensitivity cardiac troponin T and I. Receiver-operation-characteristic curves displaying the prognostic accuracy for all-cause mortality during the 24-month follow-up of high-sensitivity cardiac troponin I and high sensitivity cardiac troponin T.
The bleeding time test has been available for many years as a means of evaluating platelet function during hemostasis. Under controlled conditions an incision is made in the skin and the duration of bleeding measured using a modified template device.
Although several modifications of this test have been devised to improve it, the test is still highly operator-dependent, plagued by a lack of clinical reproducibility, and affected by numerous technical factors such as location of the incision, pressure applied, operator experience, and patient factors such as age, gender, diet, hematocrit, skin laxity and medications. Over the past decade, studies have shown the bleeding time is not reliable as a screening test for perioperative bleeding or as a diagnostic test for bleeding disorders (Arch Path Lab Med, 1996; 120:353-56; Arch Surg, 1998; 133:134-39; Clin Chem 2001; 47: 1204-1211).
Accordingly, East Side Clinical Laboratory has made the decision to discontinue offering the bleeding time test. In the absence of the bleeding time, a careful clinical history including family, dental, obstetric, surgical, traumatic injury, transfusion, and drug history is recommended. In addition, the most common hemostatic disorders can be ruled out by performing screening tests of coagulation (PT and aPTT), a platelet count, and ruling out von Willebrand’s disease (Factor VIII, von Willebrand factor Antigen, Ristocetin Cofactor). If these tests are negative the possibility of a platelet function disorder can be investigated by performing platelet aggregation testing.
Please contact us at 401.455.8400 if you have any further questions.
Walther M. Pfeifer, MD
East Side Clinical Laboratory