Skip to main content
Journal of Clinical Microbiology logoLink to Journal of Clinical Microbiology
. 2023 Apr 18;61(7):e03189-20. doi: 10.1128/jcm.03189-20

Pandemic Demand for SARS-CoV-2 Testing Led to Critical Supply and Workforce Shortages in U.S. Clinical and Public Health Laboratories

Nancy E Cornish a,, Laura H Bachmann b, Daniel J Diekema c, L Clifford McDonald d, Peggy McNult e, Jonathan Stevens-Garcia e, Brian H Raphael b, Melissa B Miller f
Editor: Romney M Humphriesg
PMCID: PMC10358151  PMID: 37070976

ABSTRACT

COVID-19 has brought unprecedented challenges to clinical and public health laboratories. While U.S. laboratories have continued striving to provide quality test results during the pandemic, the uncertainty and lack of supplies became a significant hurdle, hindering day-to-day laboratory operations and the ability to increase testing capacity for both SARS-CoV-2 and non-COVID-19 testing. In addition, long-standing laboratory workforce shortages became apparent, hindering the ability of clinical and public health laboratories to rapidly increase testing. The American Society for Microbiology, the College of American Pathologists, the National Coalition of STD Directors, and the Emerging Infections Network independently conducted surveys in 2020 and early 2021 to assess the capacity of the nation’s clinical laboratories to respond to the increase in demand for testing during the COVID-19 pandemic. The results of these surveys highlighted the shortages of crucial supplies for SARS-CoV-2 testing and supplies for other routine laboratory diagnostics, as well as a shortage of trained personnel to perform testing. The conclusions are based on communications, observations, and the survey results of the clinical laboratory, public health, and professional organizations represented here. While the results of each survey considered separately may not be representative of the entire community, when considered together they provide remarkably similar results, further validating the findings and highlighting the importance of laboratory supply chains and the personnel capable of performing these tests for any response to a large-scale public health emergency.


The American Society for Microbiology (ASM), the College of American Pathologists (CAP), the National Coalition of STD Directors (NCSD), and the Emerging Infections Network (EIN) conducted separate surveys from March 2020 through February 2021 to assess the capacity of the nation’s laboratories to respond to the COVID-19 pandemic testing demands. These survey results consist of data, unpublished or published in part on the corresponding professional organizations websites. The surveys highlighted the shortages of crucial supplies for SARS-CoV-2 testing and supplies for other routine laboratory diagnostics, as well as a shortage of trained personnel to perform testing. Each survey included in this commentary focused on different selected groups of clinical laboratory professionals: clinical microbiologists, public health professionals, pathologists, and the clinical subspecialty of infectious disease specialists. These four surveys, taken collectively, offer a compelling view of the challenges that laboratories encountered when testing for a new infectious agent, SARS-CoV-2, as the COVID-19 pandemic unfolded.

ASM SURVEYS

Laboratory testing supply shortages came to ASM’s attention in early March 2020 on the ASM listserv, ClinMicroNet (CMN) (1), a global online forum where approximately 850 clinical microbiology laboratory directors share guidance, challenges, and opportunities faced by the clinical and public health laboratory community. CMN first reported SARS-CoV-2 testing supply shortages of nasopharyngeal swabs and RNA extraction kits. The concern was that increased demand for testing early in the pandemic had the potential to quickly exhaust supplies during a time in which expansive testing was essential to establish the scope of the outbreak in the United States.

On 12 March 2020, ASM asked members of the CMN via open email to the listserv to share where the bottlenecks were occurring in providing laboratory tests for the detection of SARS-CoV-2. Responses included the requirement of two molecular targets in nucleic acid amplification tests (NAATs), the Emergency Use Authorization (EUA) process, and shortages in supplies and reagents. CMN members remained concerned that if testing volume increased dramatically over the coming weeks, clinical laboratories would be unable to provide tests because of the supply shortages of critical test components (1).

In addition to the initial shortages of test components, shortages of commercially available universal transport media/viral transport media (UTM/VTM) were reported on CMN on 13 March 2020 (1). Years prior to the pandemic, most clinical laboratories had transitioned from making UTM/VTM to purchasing it from commercial suppliers because it saved staff time and reduced cost. However, as a result of the shortages, clinical laboratories resorted to making their own transport media or validating the use of other types of transport fluids, such as saline, to keep up with test demand. These tasks put a strain on laboratory staff time and materials, which were in short supply. Reported shortages continued to expand and were evident in materials used at every step of testing—collection swabs and devices, transport media, and NAAT components, such as primers and probes, master mix, pipette tips, and commercial kits. Shortages were also unpredictable, which led to laboratories determining which testing platforms to use based on the supplies on hand on a day-to-day basis. The laboratory supply chain relies on sources worldwide and was stretched beyond capacity to accommodate global testing as clinical laboratories worked to build testing capacity and keep up with demand.

ASM continued to monitor the CMN listserv discussions and determined that real-time laboratory supply data were needed to raise the visibility of this crisis (1). In April 2020, ASM and the Association for Supply Chain Management (ASCM) decided to jointly build an online tool, the Clinical Microbiology Supply Survey and Capacity tool (CMSSC), to collect data that could help assess how the availability of laboratory supplies impacted the nation’s response to the pandemic.

The increase in SARS-CoV-2 testing and the associated shortages began to impact routine bacteriology, mycobacteriology, mycology, parasitology, and sexually transmitted infection (STI) diagnostic testing during the summer of 2020 (2, 3). Manufacturers, in many instances, had switched to producing SARS-CoV-2-specific supplies as demand increased for SARS-CoV-2 testing. In addition, demand for routine test requests dropped because of the cessation of elective medical procedures and the transition to telehealth clinic visits. When parts of the United States reopened and clinic visits, procedures, and laboratory test requests resumed, broader shortages in clinical microbiology laboratory supplies became widespread. Most impacted were bacteriology (i.e., routine culture) and STI testing. ASM clinical laboratory listservs, CMN and DivC (1) members collaborated to find laboratories that could perform tests or supply and/or trade reagents so testing could continue.

In September 2020, CMSSC was launched to collect data from U.S. Clinical Laboratory Improvement Amendments of 1988 (CLIA)-certified laboratories on COVID-19 and non-COVID-19 laboratory supply shortages. This tool aggregated anonymized data (4) posted weekly through mid-January 2021. A total of 147 clinical laboratories responded to the surveys over this time period. Laboratories were asked to report all capacity data, independent of whether they were experiencing shortages. During this time, COVID-19 testing capacity (calculated as the number of tests performed out of total testing capacity if all supplies were received) remained consistent at an average of 44% (Fig. 1). The highest reported shortages were commercial test kits and consumables (e.g., pipette tips) for commercial and laboratory-developed tests. Limitations in routine bacteriology testing capacity, which was impacted by shortages in culture media, ranged from 94.0% of laboratories during the week of 11 September 2020 down to 39% during the week of 20 November 2020. However, at the end of survey (8 January 2021), 48% of laboratories still reported shortages in bacteriology. Likewise, limitations in STI testing capacity ranged from 88.9% (week of 11 September 2020) down to 35.0% by the end of the survey (Table 1).

FIG 1.

FIG 1

ASM survey: COVID-19 testing capacity and volume.

TABLE 1.

ASM survey: average percentage of laboratories with a shortage of suppliesa

Wk Avg % of laboratories with supply shortages
Bacteria Fungi Mycob Parasites STI
11 Sep 2020 94.0 47.0 14.0 0.0 88.9
17 Sep 2020 80.0 58.0 13.0 9.0 67.5
24 Sep 2020 67.0 53.0 21.0 8.0 77.8
01 Oct 2020 64.0 33.0 17.0 0.0 72.7
08 Oct 2020 67.0 50.0 19.0 5.0 69.6
15 Oct 2020 53.0 39.0 23.0 8.0 53.8
22 Oct 2020 47.0 50.0 15.0 0.0 57.1
10 Nov 2020 56.0 12.0 27.0 14.0 65.8
20 Nov 2020 39.0  5.0 35.0 18.0 70.0
02 Dec 2020 51.0 29.0 39.0 16.0 46.0
09 Dec 2020 58.0 21.0 26.0 11.0 59.0
08 Jan 2021 48.0 19.0 29.0 9.0 35.0
a

Cell shading indicates the following: dark gray shading, 0 to 5%; light gray shading, 6 to 20%; and no shading, 21 to 100%.

b

Myco, Mycobacteria.

The CMSSC gathered local laboratory data and aggregated it to demonstrate widespread laboratory shortages. This real-time supply shortage data illustrated the laboratory’s continued daily testing struggles, quickly expanding beyond SARS-CoV-2 testing. The diagnostic supply chain is a complex system that was strained beyond expectation despite the existence of contingency plans intended to address supply chain shortages to meet expanded testing needs, due to the unprecedented worldwide pandemic disruption of manufacturing activities. Some laboratories were able to purchase additional or different test platforms to increase testing volume even though supplies were not guaranteed or readily available for any platform. Many laboratories without the budget to utilize this approach were unable to meet testing demands.

CAP SURVEYS

The College of American Pathologists (CAP) is an organization of board-certified physicians that serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine. CAP regularly surveys its membership on issues of interest to pathologists and other laboratory professionals. Due to the impact of COVID-19 on pathology and laboratories, a series of surveys were developed and sent to pathologists nationwide to evaluate the impact of the pandemic on pathologists, pathology, and laboratory practices.

The first survey, the CAP Laboratory COVID-19 Impact Study (5), was conducted between 23 April and 30 April 2020 to gather data on the challenges that pathologists and the laboratories they lead were facing in responding to the national emergency. The CAP surveyed 3,784 laboratory directors from CAP-accredited laboratories nationwide and received 434 responses for an 11.5% response rate. About 65% of the respondents were from hospital-based laboratories; of these, 43% were based in nonacademic hospitals, and 22% were based in academic hospitals. Although the low response rate may have led to somewhat biased results, it is likely the surveyed group of CAP-accredited laboratory directors is a uniform group with similar characteristics and that this self-selected subgroup is representative of the larger group of clinical laboratory directors. This survey revealed key barriers to expanding testing and the impact on pathologists and other laboratory professionals. The survey confirmed that while clinical laboratories were attempting to expand testing, >60% of laboratory directors continued to report difficulties in obtaining critical supplies needed to conduct SARS-CoV-2 testing. According to the survey, nearly 60% of laboratories nationally were providing SARS-CoV-2 testing. Approximately 80% of those laboratories providing SARS-CoV-2 tests reported that they had the capacity to perform more testing than their current levels at that time but were hampered by the lack of supplies. The survey documented that laboratories faced substantial challenges in obtaining supplies necessary for SARS-CoV-2 testing. Of note, 69% reported difficulty in acquiring test kits to conduct SARS-CoV-2 testing, 66% reported difficulty in acquiring nasopharyngeal swabs, and 62% reported difficulty in acquiring VTM/UTM to conduct the tests. Surveyed laboratory directors also reported increased stress on pathologists and laboratory professionals because of longer work hours, leading to an increase in burnout. In addition, all laboratories faced substantial financial stresses, regardless of whether they provided SARS-CoV-2 testing. Nearly all laboratories surveyed reported substantial losses in revenues, including the need to furlough employees in some cases, which may have exacerbated laboratory staff shortages.

From 8 to 13 June 2020, a second survey was conducted as a follow-up to the initial study to gather data and analyze trends on the challenges that pathologists and the laboratories they lead were facing (6). The survey was sent to 3,723 laboratory directors from CAP-accredited laboratories nationwide and 306 responses were received, for an 8.2% response rate. Nearly 70% of the respondents were from hospital-based laboratories; of that, approximately two-thirds were based in nonacademic hospitals and approximately one-third were based in academic hospitals. The survey found substantial increases in SARS-CoV-2 testing capability available to patients despite ongoing issues with obtaining diagnostic supplies. The new survey confirmed what laboratory directors stated in late April 2020 that they expected their laboratories to increase capacity and offer more tests in their communities in the following weeks. According to those responding to the survey, 76% of laboratories were providing SARS-CoV-2 testing and 70% of laboratories providing SARS-CoV-2 tests reported that they had the capacity for more testing than current levels but were limited by lack of supplies. The number of laboratory directors reporting difficulties acquiring supplies for testing decreased slightly compared to April. However, this survey confirmed that laboratories still faced considerable challenges obtaining supplies necessary for SARS-CoV-2 testing. Of the laboratory directors responding to the survey, 64% reported difficulty in acquiring reagents for platforms/test kits to conduct SARS-CoV-2 testing, 60% reported difficulty in acquiring flocked nasopharyngeal swabs to collect and transport patient samples, 55% reported difficulty in acquiring VTM/UTM to conduct the tests, and 30% reported difficulty in getting personal protective equipment. Surveyed laboratory directors reported they could perform more testing if they had all the necessary supplies. At the same time, laboratory directors indicated increased stress on pathologists and laboratory professionals because of burnout and the negative effects of furloughs and staffing shortages.

From 27 January through 11 February 2021, a third survey, the COVID-19 Pathologist Impact Survey (7; C. Fiegl, College of American Pathologists Advocacy Communications, unpublished data survey data), was sent to all board-certified pathologists and directors of CLIA-certified laboratories. CAP received 680 responses, with a 4.6% response rate. The survey found that many laboratory directors had difficulties obtaining certain SARS-CoV-2 testing supplies over the prior 3 months—particularly for reagents for platforms/testing kits and pipette tips. About 45% of laboratory directors said it was difficult or very difficult over the prior 3 months to acquire reagents for platforms/test kits, and 30% reported difficulties obtaining pipette tips for SARS-CoV-2 testing. Nearly 20% of laboratory directors reported difficulty acquiring SARS-CoV-2 testing instruments, flocked nasopharyngeal swabs, and VTM/UTM.

In addition, workforce shortages were reported by over 60% of laboratory directors. They stated that they could not hire enough staff to meet the testing demand for SARS-CoV-2 testing over the prior 3 months reported (6, 7). The most frequently cited challenge was finding SARS-CoV-2 testing personnel (cited by 43.4% of surveyed CLIA laboratory directors). In addition, 36% cited difficulties in obtaining adequate personnel for specimen collection, and 23% cited problems in obtaining adequate numbers of laboratory personnel who could accession specimens.

The same survey found that while, on average, the testing volume for calendar year 2020 was still lower than for 2019, the volume continued to improve in the fourth quarter and, on average, was comparable to levels for the same period in 2019 (7; Fiegl, unpublished). The average estimated 2019-2020 decline in Anatomic Pathology (AP) testing was 21%, and the average estimated 2019–2020 decline in non-COVID Clinical Pathology (CP) testing was 9%. For the fourth quarter of 2020, the average AP testing volume was only 12% lower than for the fourth quarter of 2019, and the non-COVID CP testing volume was only 4% lower than the corresponding 2019 value.

This survey additionally revealed information about the types of SARS-CoV-2 tests provided by a laboratory varied by setting and practice size (7; Fiegl, unpublished). Laboratories based in academic medical centers were most likely to provide on-site molecular high-throughput SARS-CoV-2 testing. Over 70% of respondents in laboratories based in academic medical centers said they provided these tests, compared to about 40% based in nonacademic hospitals or independent laboratories. Respondents whose laboratories provided SARS-CoV-2 molecular or antigen testing were asked about the number of unique platforms used to perform molecular SARS-CoV-2 tests. Of the 278 responses received, most reported using more than one testing platform, with >80% using two or more platforms, and about one-half of the respondents reported using three or more unique testing platforms.

SURVEYS REVEALING DISRUPTION OF SEXUAL HEALTH AND STI TESTING SERVICES

The implementation of COVID-19 mitigation measures in clinical settings, the diversion of the public health workforce to address the pandemic, and the lack of sexually transmitted diseases (STDs) and general laboratory testing supplies dramatically impacted the ability of providers and health care settings to provide sexual health services. This was concerning since the rates of nationally reportable STI have increased in the United States over the past 5 years (8). In 2018, 1.8 million cases of chlamydia (CT), 583,405 cases of gonorrhea (GC), and 35,063 cases of primary and secondary syphilis were reported to the Centers for Disease Control and Prevention (CDC) (8). Testing for GC and CT is often performed with an NAAT and occurs in multiple settings, including clinical, commercial, and public health laboratories (PHLs). Multiple manufacturers offer diagnostic test kits for GC and CT, several of which use instrumentation that can accommodate high specimen throughput. Specimens collected for screening and diagnosis can include urine and/or swabs from genital and extragenital (e.g., pharyngeal and rectal) sites. A 2016 survey of state and local PHLs revealed that more than 80% of responding laboratories offer GC and CT NAATs (9). Among these laboratories, more than 2.2 million GC and CT tests were performed in 2016. Over 50% of the PHLs surveyed used a commercial NAAT assay from a single manufacturer.

This confluence of events led the CDC Division of Sexually Transmitted Disease Prevention (DSTDP) to issue a “Dear Colleague Letter” (DCL) (10) on 6 April 2020 that provided guidance for the clinical management of STI in jurisdictions that were experiencing the disruption in clinical services. The guidance emphasized a flexible and practical approach to providing sexual health services, supported the use of expanded syndromic management by using the patient’s symptoms to make the diagnosis, and encouraged the implementation of telehealth approaches, including the use of innovative STI testing methods and the development of new partnerships to meet the challenges posed by the pandemic.

In May 2020, the NCSD conducted a survey, which reported that 66% of U.S. STD programs experienced reduced capacity to conduct sexual health screening and testing, and 42% reported reducing sexual health testing by more than 50% (11). A follow-up survey in August 2020 documented that 95% of STD programs reported continued disruptions to operations. The survey also demonstrated efforts to innovate and deliver sexual health services outside the clinic, with 36% of responding STD programs implementing telehealth services and 27% implementing at-home or non-clinic-based testing programs (12). Despite efforts to maintain clinical services during the pandemic, a shortage of STI test kits and laboratory supplies, most notably for GC and CT NAATs, followed quickly on the heels of clinic closures and staffing shortages.

STD surveillance data indicated substantial decreases, starting in March 2020, in reported cases of GC, CT, and syphilis compared to the same time period in 2019 (13, 14). Further evidence of testing declines was documented when a review of data from a large commercial laboratory revealed a 25% decline in GC and CT testing in patients aged 15 to 60 years from February through May of 2020 compared to 2019. The reasons for testing declines were likely multifactorial, including the lack of access because of a decline in in-person visits (i.e., clinic closures and reduced clinic hours), reduced routine screening, and the unavailability of GC and CT testing due to diagnostic test kit shortages. In support of the shift from screening to diagnostic testing, the proportion of positive tests performed for each organism increased during this time (T. Gift, CDC, unpublished analysis and trending of test volume during the COVID pandemic).

In response to increasing reports of STI diagnostic test kit shortage, DSTDP issued a 8 September 2020 DCL (15) that offered guidance to prevention programs, including clinics, on approaches for prioritizing GC and CT testing when STI diagnostic test kits are in short supply. The goal of the guidance was to increase awareness of the issue among providers and health care settings and to maximize the number of infected individuals identified and treated, while prioritizing individuals most likely to experience complications. National and local media outlets also highlighted reduced STI testing availability, bringing public attention to the crisis (1618). A DSTDP survey of 41 STD clinics and 59 STD programs (50 states, 7 directly funded cities, and 2 U.S. territories) administered 1 December 2020 through 28 January 2021 found that 44% of STD clinics and 38% of STD programs reported shortages of GC/CT NAAT tests (19, 20). These results agree with the findings of the CMSSC and EIN surveys (4, 21). Despite the declines observed in reporting of STIs in the early part of the year, more recent data document increases in syphilis and GC up to and above 2019 levels, providing evidence of continued recovery from the diagnostic test kit shortage and documentation that STIs may have increased in 2020 (13).

EIN SURVEY

In August 2020, a working group of the Emerging Infections Network (EIN) proposed its own survey to assess the extent and the impact of these shortages (22). The EIN is a clinician-based sentinel network funded by CDC and the Infectious Diseases Society of America. Comprised of over 2800 participants (mostly United States based), the EIN is designed to detect new or unusual clinical events, clusters, outbreaks, and to discuss the clinical aspects of emerging infections. The seven-question survey was distributed on 25 August 2020, 3 September 2020, and 10 September 2020 to 1,725 EIN (mostly Infectious Disease [ID] clinician) members. The survey was sent separately to clinical microbiology laboratory directors through the ClinMicroNet and the ASM DivC listserv (1). The EIN response rate was 34% (613/1795), and 85 laboratory directors responded.

Complete survey questions and results are available (21). A major finding was that awareness of the impact of SARS-CoV-2 testing demand on the timeliness or availability of other tests was far greater among laboratory directors than among EIN members, who are mostly infectious diseases physicians. While 86% of laboratory directors reported either delays in results or unavailability of non-SARS-CoV-2 tests because of supply or personnel shortages, only 32% of EIN members reported awareness of such delays or unavailability.

Most respondents reported delays in testing. However, approximately 17% of both EIN members and laboratory directors reported testing not being available. The tests affected most by delays or unavailability were those for GC and CT, reported by close to 40% of respondents, followed by various other molecular assays (HIV, cytomegalovirus, Epstein-Barr virus, hepatitis C virus, respiratory pathogen panels, Clostridioides difficile, and methicillin-resistant Staphylococcus aureus). Some culture-based tests were also reported to be affected by a smaller proportion of respondents (<10%), presumably because of media shortages.

Specific shortages mentioned included: various media, reagents (many for extraction steps), swabs, and cartridges for major commercial molecular platforms. While reagent shortages were most often implicated in test delays or unavailability (e.g., by 85% of laboratory directors), personnel shortages were also important contributors, reported by 35% of EIN members and 38% of laboratory directors. Many open-text comments referenced overwork and stress among laboratory personnel, with some reports of staff leaving the laboratory; one-third of laboratory directors reported that communication with laboratory staff deteriorated because of the demand for SARS-CoV-2 testing. Several comments also noted the need to send molecular tests to referral laboratories so that limited resources could be diverted to SARS-CoV-2 testing. As a result, 60% of laboratory directors reported that the overall availability of laboratory services deteriorated because of the demand for SARS-CoV-2 testing, with only one director reporting that availability had improved.

Some survey comments suggested that hospital-based laboratories were concerned about being tasked with large-scale SARS-CoV-2 screening of asymptomatic populations. Some directors thought this type of screening detected relatively few positive results or that it was more appropriate for PHLs.

Overall, the EIN survey demonstrated that SARS-CoV-2 test demand was a major stressor for clinical laboratories in the United States, with supply chain and personnel issues leading to delays and unavailability of tests, with the greatest impact being on STI testing. The survey revealed differences in responses between EIN members (mostly ID clinicians) and clinical microbiology laboratory directors; the laboratory directors perceived more challenges with test turnaround time and availability than the ID clinicians. It is important to acknowledge that generalist clinicians, not ID clinicians, most often order STI testing (23).

WORKFORCE SHORTAGES

It was noted in three of the surveys (57; Fiegl, unpublished) that both the hospital and the laboratory workforce were affected because of a reduction in hospital and clinic visits and laboratory test requests resulting in loss of revenue. This impacted laboratory operations and hospital administrations employed various strategies to compensate for this, including laying off or furloughing employees or having employees work longer hours. In the public health sector, it was noted that the diversion of the public health workforce to support COVID-19 pandemic-related work left few people to address routine public health programs (19). In addition to the overwhelming testing burden and daily supply shortage issues that affected the laboratory workforce, there were several other challenges surrounding the laboratory workforce. These include a 10% vacancy rate already existing in the clinical laboratory, an expected retirement rate of 17% in the next few years (24), and the realization that the profession suffers from low pay, repetitive work, weekend and third-shift hours, and lack of visibility. These surveys also revealed that as SARS-CoV-2 testing increased, the lack of enough qualified testing personnel and ancillary support staff who could collect, and accession specimens put additional stress on laboratory operations (2530). Laboratory workforce shortages led to strategies such as salary increases, delayed retirement, hiring of traveling medical laboratory scientists, and training of research staff to run clinical testing to compensate for workforce shortages (M. Miller, Clinical Microbiology and Molecular Microbiology Laboratories, University of North Carolina School of Medicine, unpublished data).

CONCLUSIONS

All of the surveys discussed here revealed that supply and workforce shortages prevented laboratories from meeting the high demand for SARS-CoV-2 testing and adversely impacted routine microbiology molecular tests and culture test orders. In addition, the full impact of the shortages was not realized until hospitals in the United States resumed elective medical and hospital procedures and clinic visits, and routine laboratory test orders increased.

As the pandemic unfolded, various strategies were employed by clinical laboratories and public health partners to maintain the needed testing levels, including having multiple testing platforms available to help manage supplies that may be available for one platform but not for others. Many laboratories collaborated to trade supplies to be able to continue testing or sent testing out to other laboratories if supplies ran out. Rather than using diagnostic testing, clinicians had the option to use the patient’s signs and symptoms (i.e., syndromic management) when it was safe to do so, to diagnose and prescribe treatment (10).

Manufacturers also encountered challenges with addressing shortages in testing components. For example, for one commercial assay that detects CT and GC simultaneously, specimens are collected using specific collection devices that contain buffer that stabilizes nucleic acids. Swab specimens are placed in a tube with a penetrable cap that allow tubes to be inserted directly into an automated system. However, the same tubes and penetrable caps were initially used in the manufacturers’ SARS-CoV-2 assay. The manufacturer developed uncapped tube options for the SARS-CoV-2 assay to mitigate supply chain issues with the penetrable caps (31).

While the results of each survey considered separately may not be representative of the entire community, their results are more widely representative when considered together. In addition, these surveys provide remarkably similar results, further validating the findings and highlighting the importance of laboratory supply chains and the personnel capable of performing these tests for any response to a large-scale public health emergency.

ACKNOWLEDGMENTS

Partners for this study were as follows: CDC partners—Roxanne Barrow, Evelyn Nash, Shaunta Wright, Guoyu Tao, Hillard Weinstock, Reynolds Salerno, Nancy Anderson, Víctor R. De Jesús, Diego Arambula, Bin Chen, and Jodi Jackson; EIN partners—John T. Brooks, Thomas File, Jr., Philip M. Polgreen, and Susan Beekmann; ASM partners—Stefano Bertuzzi, Abe Eshkenazi, and Peter Bolstorff; CAP partners—we thank Charles Fiegl and the CAP for providing the survey data used here with their permission.

The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. Use of trade names and commercial sources is for identification only and does not imply endorsement by the Centers for Disease Control and Prevention, the Public Health Service, or the U.S. Department of Health and Human Services.

The views expressed in this article do not necessarily reflect the views of the journal or of ASM.

Footnotes

[This article was published on 18 April 2023 with errors in the article text. The text was corrected in the current version, posted on 24 April 2023.]

Contributor Information

Nancy E. Cornish, Email: NCornish@cdc.gov.

Romney M. Humphries, Vanderbilt University Medical Center

REFERENCES


Articles from Journal of Clinical Microbiology are provided here courtesy of American Society for Microbiology (ASM)

RESOURCES