FROM THE EDITOR


Omicron enters the COVID-19 battle


A


By Linda Wilson Senior Editor


s 2022 dawns, a world weary from battling SARS-CoV-2 faces a new variant of the virus: Omicron (B.1.1.529).


The World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) have classified Omicron as a variant of concern (VOC). It has a large number of muta- tions, including 26-32 in the spike protein. The good news is that most diagnostic RT-PCR


and antigen tests do not appear to be impacted by Omicron, according to the WHO. The issue is whether a diagnostic test will produce accurate results if a mutation occurs in the genetic target that the test is designed to detect. If a test detects multiple targets, it will still detect the presence of SARS-CoV-2, via the other


targets, and produce accurate test results. Since many of the widely used tests do, in fact, use multiple targets to detect the presence of SARS-CoV-2 in a specimen, they should continue to produce accurate results, according to the U.S. Food and Drug Administration (FDA), which has been assessing the performance of various tests based on the mutations present in Omicron. The agency also has been posting the results of its assessments online, so clinical labs have the information they need to provide diagnostic testing services. Most of the sequences of Omicron that labs have performed show a deletion


in the S gene. That is why vendors whose tests target the S gene (in addition to other targets) have suggested that their tests could be used to flag specimens that may contain Omicron. Those specimens could then be prioritized for sequencing to confirm the presence of the variant. Sequencing is necessary to make an official determination on the presence of Omicron because the S-gene deletion can also be found in Alpha and subsets of Gamma and Delta, according to the WHO.


Sequencing specimens to track the activity of various SARS-CoV-2 variants is also a central component of surveillance efforts. As of early December, the WHO said Omicron already had been identified in 63 countries. The WHO also predicts that Omicron will spread more rapidly than Delta did. “It is spreading faster than the Delta variant in South Africa where Delta circulation was low, but also appears to spread more quickly than the Delta variant in other countries where the incidence of Delta is high, such as in the United Kingdom. Whether Omicron’s observed rapid growth rate, in countries with high levels of population immunity, is related to immune evasion, intrinsic increased transmissibility, or a combination of both remains uncertain. However, given the current available data, it is likely that Omicron will outpace the Delta variant where community transmission occurs,” the WHO said. The WHO also said the overall risk presented by Omicron is very high.


“Preliminary evidence suggests potential humoral immune escape against infection and high transmission rates, which could lead to further surges with severe consequences.” What all of this means for clinical laboratorians is clear: They are likely to spend a lot of their time in 2022, as they did in 2020 and 2021: testing specimens for evidence of SARS-CoV-2. I welcome your comments, questions, and opinions – please send them to me at lwilson@mlo-online.com.


MEDICAL LABORATORY OBSERVER Vol.54, No.1


Group Publisher/Executive Editor Kristine Russell


krussell@mlo-online.com


Senior Editor Linda Wilson


lwilson@mlo-online.com


Managing Editor Gail Castanho gcastanho@endeavorb2b.com


Graphic Artist Patti Connors pconnors@endeavorb2b.com


Audience Development/List Rentals Laura Moulton lmoulton@endeavorb2b.com


Ad Traffic Coordinator: Ray Porter rporter@endeavorb2b.com


eProduct Coordinator Mary Haberstroh mhaberstroh@endeavorb2b.com


ADVERTISING


East Coast/Midwest Sales (except IL) Classified/Recruitment Advertising Carol Vovcsko (941) 321-2873 cvovcsko@mlo-online.com


South/West Coast/Illinois Sales Lora Harrell (941) 328-3707 lharrell@mlo-online.com


MLO EDITORIAL ADVISORY BOARD


John Brunstein, PhD, Biochemistry (Molecular Virology) President & CSO PathoID, Inc., British Columbia, Canada


John A. Gerlach, PhD, D(ABHI) Laboratory Director Michigan State University, East Lansing, MI


Barbara Strain, MA, SM(ASCP), CVAHP Principal, Barbara Strain Consulting LLC Formerly Director, Value Management University of Virginia Health System, Charlottesville, VA


Jeffrey D. Klausner, MD, MPH Professor of Preventive Medicine in the Division of Dis- ease Prevention, Policy and Global Health, Department of Preventive Medicine at University of Southern California Keck School of Medicine.


Susan McQuiston, JD, MT(ASCP), SCy(ASCP) Instructor, Biomedical Laboratory Diagnostics Program Michigan State University, East Lansing, MI


Donna Beasley, DLM(ASCP) Director


Huron Healthcare, Chicago, IL


Anthony Kurec, MS, H(ASCP)DLM Clinical Associate Professor, Emeritus SUNY Upstate Medical University, Syracuse, NY


Suzanne Butch, MLS(ASCP)CM , SBBCM Freelance Consultant, Ann Arbor, MI


Paul R. Eden, Jr., MT(ASCP), PhD Lt. Col., USAF (ret.) (formerly) Chief, Laboratory Services 88th Diagnostics/Therapeutics Squadron Wright-Patterson AFB, OH Daniel J. Scungio, MT (ASCP), SLS, CQA (ASQ) Consultant at Dan the Lab Safety Man and Safety Officer at Sentara Healthcare, Norfolk, VA


CORPORATE TEAM , DLMCM


CEO Chris Ferrell CFO William Nurthen CRO/CMO June Griffin


Chief Administrative and Legal Officer Tracy Kane COO Patrick Rains


EVP Special Projects Kristine Russell


2477 Stickney Point Rd., Suite 221B Sarasota, FL 34231 Phone: (941) 388-7050 Fax: (941) 388-7490 www.mlo-online.com


MLO - MEDICAL LABORATORY OBSERVER


(ISSN: 0580-7247). Published monthly, with an additional issue in NOVEMBER, by Endeavor Business Media, LLC., 2477 Stickney Point Rd, Suite 221B, Sarasota, FL 34231 (941) 388-7050. Subscription rates: $127.60/ year in the U.S.; $154.88 Canada/Mexico; Intl. subscriptions are $221.43/year. All issues of MLO are available on microfilm from University Microfi lms International, Box 78, 300 N. Zeeb Rd., Ann Arbor, MI 48106. Current single copies (if available) $15.00 each (U.S); and $20.00 each (Intl.). Back issues (if available) $17.60 each (U.S.); $22.00 each (Intl.). Payment must be made in U.S. funds on a U.S. bank/ branch within the continental U.S. and accompany request. Subscription inquiries: subscriptions@endeavorb2b.com. MLO is indexed in the Cumulative Index for Nursing and Allied Health Literature and Lexis-Nexis. MLO Cover/CE, Clinical Issues, and Lab Management features are peer reviewed. Title®


registered U.S. Patent Offi ce. Copyright© 2022 by Endeavor


Business Media, LLC. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage-and- retrieval system, without written permission from the publisher. Offi ce of publication: Periodicals Postage Paid at Nashville, TN 37209 and at additional mailing offi ces. Postmaster: Send address changes to Omeda (MLO Medical Laboratoy Observer), PO Box 3257, Northbrook, IL 60065-3257.


4 JANUARY 2022 MLO-ONLINE.COM Printed in U.S.A.


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50