Vaginitis testing, using nucleic acid amplification, is associated with higher Chlamydia trachomatis and Neisseria gonorrhoeae testing rates. Molecular testing may provide more accurate vaginitis diagnoses and address missed C. trachomatis and N. gonorrhoeae testing to reduce screening biases.
Background
Data are lacking on adherence to Centers for Disease Control and Prevention testing guidelines among insured US women presenting with vaginal health complaints; thus, we quantified vaginitis testing frequency and assessed the co-testing rate for causes of vaginitis and Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG).
Methods
This was a retrospective analysis of deidentified data from a medical database. Information from women aged 18 to 50 years was obtained from the Truven MarketScan Commercial Database (2012–2017) using Current Procedural Terminology (CPT) codes; χ2 testing was applied to determine co-testing differences for CT/NG based on vaginitis test type. Odds ratios were calculated to determine the association with CT/NG screening across vaginitis testing categories.
Results
Approximately 48% of 1,359,289 women received a vaginitis diagnosis that involved a laboratory-based test. Of these women, only 34% were co-tested for CT/NG. CT/NG co-testing was highest for those with nucleic acid amplification testing for vaginitis and lowest for those with no vaginitis testing CPT code (71% vs. 23%, respectively; P < 0.0001).
Conclusions
The vaginitis nucleic acid amplification test, indicated by CPT code, was associated with statistically significantly higher CT/NG testing rates. Molecular diagnostics may support vaginitis testing in settings that have limited opportunities for microscopy and clinical examinations and offer greater opportunity to offer comprehensive women's health care that includes testing for chlamydia and/or gonorrhea infections.
Vaginitis, which results in 5 to 10 million health care visits annually,1 is characterized by inflammation of the vagina and is most often associated with bacterial vaginosis (BV), Candida species vulvovaginal candidiasis (VVC), and Trichomonas vaginalis (TV; in total, accounting for 70%–95% of cases).2,3 Left untreated, vaginitis can lead to pelvic discomfort, pain during intercourse, and other organism-specific complications. For example, BV, the most common cause of vaginitis, increases the risk of acquiring HIV and other sexually transmitted infections (STIs) and may also lead to pregnancy complications and preterm labor.4,5 All 3 causative agents of vaginitis are easily treatable when accurately diagnosed.6 The standard of care for diagnosis of vaginitis is clinical evaluation.6–8 The examination requires the correct clinical tools, supplies, training, and experience; it involves several components/steps that can be subjective, and often not accurate or sufficiently comprehensive.8,9 Even before the COVID-19 pandemic, many practices had moved away from speculum-assisted pelvic examinations,10 including those at the institutions of the authors, and examination tables are available in fewer and fewer patient care rooms. This shift in practice was exacerbated by clinical protocols and a shift to telemedicine instituted as a result of COVID-19.
Amsel criteria represent the criterion standard for a BV diagnosis and include assessment of a vaginal specimen across 4 features: microscopic detection of clue cells, detection of amines (fishy odor) using potassium hydroxide, qualification of vaginal discharge, and a pH >4.5. This test is associated with a clinical sensitivity ranging from 53% to 97% and a clinical specificity ranging from 40% to 100%.3,6,11 However, in the absence of a full pelvic examination and available microscopy, the Amsel criteria are limited to qualification of vaginal discharge, and potentially an amine test if potassium hydroxide is available for a self-collected vaginal swab. Use of only one of the criteria to define BV reduces specificity while requiring all criteria to be present reduces sensitivity. The most frequently used diagnostic tool for VVC and TV, microscopic examination of a vaginal sample (wet prep), is associated with a clinical sensitivity of 38% to 83% and 50% to 74%, respectively.2,3,11,12 Diagnostic approaches for vaginitis without using microscopy-based evaluation result in reduced sensitivity and specificity; approximately 30% of providers do not have access to microscopy needed to adhere to guideline-specified examination.9 Because of the low sensitivity/specificity provided by common clinical vaginitis diagnostic approaches and a lack of consistent adherence to guidelines, molecular testing has been increasingly recommended and incorporated as an accurate, reliable means to diagnose vaginitis.3,6
The potential of molecular-based testing to provide superior diagnostic performance for detection of vaginitis was initially identified by the Centers for Disease Control and Prevention in 2002.13 Previous work has demonstrated relatively high sensitivity and specificity (90%–100%) over traditional clinical microscopy for all 3 causes of vaginitis,8 and Centers for Disease Control and Prevention guidelines identified molecular testing as a preferred method for TV detection in 2015 and 2021.6,14 Molecular testing requires less equipment in the provider's office, involves straightforward collection techniques, and requires less clinician time.15
Because of the high rate of coinfections between causes of vaginitis and STI,16 their shared route of transmission (especially given that TV is an STI), shared symptoms (e.g., abnormal discharge, dysuria, etc), and the difficulty in diagnosing STI clinically, women with symptoms related to vaginitis should also be tested for common STIs as part of comprehensive patient care (i.e., Chlamydia trachomatis [CT)] and Neisseria gonorrhoeae [NG]).2,6,16 The exception would be those women for whom there is clinical suspicion of VVC with documented related cause, such as recent antibiotic use. The high coinfection rate of CT/NG in women who are positive for vaginitis necessitates further testing to provide comprehensive care and to prevent potential complications such as infertility, pelvic inflammatory disease, urethritis, and other poor outcomes associated with untreated STIs.17 Appropriate CT/NG testing for patients presenting with vaginitis is important, yet few studies examine testing; to our knowledge, no programs have been implemented for this purpose at the national level. The purposes of this study were to understand the current practice in diagnostic testing for vaginitis (microscopy vs. molecular diagnostic, vs. none) among insured women (18–50 years), and to assess the rate of co-testing for CT and NG in women with a vaginitis diagnosis.
MATERIALS AND METHODS
Study Population
We used the Truven MarketScan Commercial Claims and Encounters (CCE) and the Medicare Supplement data set from 2012 to 2017 to obtain data for analysis in this study. MarketScan contains deidentified data on approximately 50 million beneficiaries, annually, with self-insurance employers and health plans from 50 states in the United States. Because administrative claims databases were designed for services and billing management, they do not contain full patient demographic information. We included women aged 18–50 years with a vaginitis diagnosis. The first vaginitis diagnosis during the study period was used for the analysis and will be referred to as the index vaginitis diagnosis. We excluded patients without continuous enrollment data for 1 year before the index vaginitis diagnosis to ensure that the index case was used. Women with a history of cancer or HIV, and women older than 50 years (the latter to limit age-associated causes of vaginitis) were excluded.
Index vaginitis was identified as a first encounter with an International Classification of Disease (ICD) code for vaginitis during the study period (ICD codes: 616.10, 131.01, 112.1, N76, N76.0, N76.1, N77.1, A59.01, or B37.3). Vaginitis testing was identified using Current Procedural Terminology (CPT) codes, grouped as follows: (1) traditional testing, which consisted of point-of-care testing and wet mount microscopy-based detection for vaginitis causes (CPT codes: 87210 or 87205); (2) DNA probe–based molecular assays for vaginitis (CPT: 87480, 87510, and 87660); (3) nucleic acid amplification test (NAAT)–based molecular assays for vaginitis (CPT: 87480, 87512, 87798, or 87799); (4) other, which likely included 1 or more categories of molecular-based testing or had some CPT codes for vaginitis testing but did not meet our case definition; and (5) no laboratory-based testing (no CPT code for vaginitis screening). CT and NG testing was identified using the CPT code on the same day as the vaginitis diagnosis (CPT: 87491 or 87591). Age at the time of the index diagnosis was defined as a categorical variable (18–24, 25–29, 30–39, and 40–50 years). The region of the index diagnosis was provided as Northeast, Central, South, West, and unknown. To account for varying health status, we quantified the Charlson Comorbidity Index (CCI),18 which standardizes comorbidity data abstracted from administrative claims databases in a weighted score including 17 comorbidities during the 1 year before the index visit.
Statistical Analysis
We estimated the distribution of age, region, and CCI score by vaginitis test at the index visit and tested for differences using the χ2 test. We investigated the co-testing of CT or NG (CT/NG) because the vast majority of CT and NG infections co-occurred. Differences in the CT/NG distributions within the vaginitis diagnosis group were assessed using the χ2 test. We estimated the unadjusted and adjusted association between the type of vaginitis test and CT/NG testing using logistic regression. All analyses, including adjusted and unadjusted odds ratios, were completed using SAS 9.4 (Cary, NC).
RESULTS
Vaginitis Testing
After applying the exclusion criteria (Fig. 1), our analytic cohort consisted of 1,359,289 women (mean age, 33 years) with a diagnosis of vaginitis (Table 1). Of those included, nearly 49.2% (n = 668,966) did not have a CPT code documented for testing (women given a diagnosis of vaginitis at their index visit but had no further testing to confirm a vaginitis diagnosis). Of those who did undergo testing, 50.9% (n = 351,316) received traditional point-of-care testing, wet mount, or culture; 44.1% (n = 304,488) received molecular diagnostic testing of either DNA probe (23.5%; n = 162,344) or NAAT testing (20.6%; n = 142,144); and approximately 5.0% (n = 34,519) were classified as other.
Figure 1.
Study cohort flow diagram. Dx, diagnosis; HIV, human immunodeficiency virus.
TABLE 1.
Age Range, Regional Distribution, and Comorbidity Data for Women With a Vaginitis Diagnosis According to Different Categories of Laboratory-Based Testing
| Overall (N = 1,359,289) | No CPT Code (n = 668,966) | Traditional Test (n = 351,316) | DNA Probe Test (n = 162,344) | NAAT (n = 142,144) | Other (n = 34,519) | P | |
|---|---|---|---|---|---|---|---|
| Age range, y | <0.0001 | ||||||
| 18–24 | 363,375 (26.7) | 171,302 (25.6) | 102,604 (29.2) | 42,260 (26.0) | 38,286 (26.9) | 8923 (25.8) | |
| 25–29 | 209,587 (15.4) | 97,442 (14.6) | 57,103 (16.3) | 25,957 (16.0) | 23,472 (16.5) | 5613 (16.3) | |
| 30–39 | 409,529 (30.1) | 198,951 (29.7) | 103,969 (29.6) | 51,507 (31.7) | 44,266 (31.1) | 10,836 (31.4) | |
| 40–50 | 376,798 (27.7) | 201,271 (30.1) | 87,640 (24.9) | 42,620 (26.3) | 36,120 (25.4) | 9147 (26.5) | |
| Region | <0.0001 | ||||||
| Northeast | 286,653 (21.1) | 144,932 (21.7) | 46,358 (13.2) | 50,857 (31.3) | 34,824 (24.5) | 9682 (28.0) | |
| Central | 220,679 (16.2) | 104,913 (15.7) | 69,285 (19.7) | 28,059 (17.3) | 13,496 (9.5) | 4926 (14.3) | |
| South | 600,312 (44.2) | 289,288 (43.2) | 172,377 (49.1) | 51,940 (32.0) | 72,316 (50.9) | 14,391 (41.7) | |
| West | 232,209 (17.1) | 121,628 (18.2) | 55,976 (15.9) | 30,182 (18.6) | 19,513 (13.7) | 4910 (14.2) | |
| Unknown | 19,436 (1.4) | 8205 (1.2) | 7320 (2.1) | 1306 (0.8) | 1995 (1.4) | 610 (1.8) | |
| CCI | <0.0001 | ||||||
| 0 | 1,229,297 (90.4) | 597,516 (89.3) | 322,576 (91.8) | 148,103 (91.2) | 129,570 (91.2) | 31,532 (91.3) | |
| 1 | 109,383 (8.0) | 59,038 (8.8) | 24,876 (7.1) | 12,170 (7.5) | 10,767 (7.6) | 2532 (7.3) | |
| ≥2 | 20,609 (1.5) | 12,412 (1.9) | 3864 (1.1) | 2071 (1.3) | 1807 (1.3) | 455 (1.3) |
Data are n (%).
Overall values for vaginitis testing categories were stratified by age range, region of testing, and CCI rating. Age group range, test region, and comorbidity percentages, within each vaginitis test category, are shown in Table 1. The 30- to 39-year-old age range group was the largest (30.1%; n = 409,529), followed by the 40- to 50-year-old age range group (27.7%; n = 376,798), and the 18- to 24-year-old age range (26.7%; n = 363,375); the 25- to 29-year-old age range (15.4%; n = 209,587) represented the smallest group in this data set (Table 1). We observed significant differences in vaginitis testing by region (P < 0.001). The South region represented the largest region by population in our sample (44.2%; n = 600,312), followed by the Northeast (21.1%; n = 286,653), the West (17.1%; n = 232,209), and the Central (16.2%; n = 220,679) regions. The CCI results showed that women included in this study had a very low comorbidity index, with 90.4% (1,229,297) having zero comorbidities. The relative percentages for age range, test region, and CCI, within each vaginitis test category, were largely similar to those for the overall population by age range, testing region, and CCI (Table 1).
Testing for CT/NG
Of those with a diagnosis of vaginitis, only 34% (465,713) were coded as having been tested for CT/NG. CT/NG testing was highest among women who received a NAAT vaginitis test and was lowest in those with no CPT code (70.8% [n = 100,597] vs. 22.8% [n = 152,482], respectively; Fig. 2). In multivariate-adjusted analyses accounting for age, region, and CCI, the odds of CT/NG testing by test type varied in a statistically significant manner. Those with a NAAT vaginitis test were approximately 8 times more likely to have CT/NG testing compared with those with no CPT code for vaginitis testing (odds ratio, 8.77 [95% confidence interval, 8.66–8.89]; P < 0.0001). Those with a traditional test or DNA probe test were also more likely to have CT/NG testing compared with those with no CPT code for vaginitis testing. However, the increased odds for a CT/NG test were only 1.8- to 2.5-fold higher (Table 2).
Figure 2.
Percent CT/NG testing by vaginitis diagnostic category. The number of women with a vaginitis diagnosis was determined within the Truven MarketScan Commercial Claims and Encounters database. The 5 classifications of laboratory testing (no CPT code, traditional, DNA probe, NAAT, and other) that were used to support a vaginitis diagnosis were counted. Within these 5 classifications, the number of women who were also tested for CT/NG was also determined. The percentage of CT/NG screening within each of the 5 classifications was determined and plotted.
TABLE 2.
Occurrence of CT/NG* Testing for Women With a Vaginitis Diagnosis Accompanied by Different Categories of Laboratory-Based Testing
| Overall (N = 1,359,289) | No CPT Code (n = 668,966) | Traditional Test (n = 351,316) | DNA Probe Test (n = 162,344) | NAAT (n = 142,144) | Other (n = 34,519) | P | |
|---|---|---|---|---|---|---|---|
| Co-screening | (N = 465,713) | (n = 152,482) | (n = 122,678) | (n = 68,698) | (n = 100,597) | (n = 21,258) | <0.001 |
| Age group, y | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | |
| 18–24 | 174,450 (37.5) | 58,304 (34.0) | 51,616 (50.3) | 25,992 (61.5) | 31,804 (83.1) | 6734 (75.5) | <0.001 |
| 25–29 | 82,862 (17.8) | 26,823 (27.5) | 22,232 (38.9) | 12,514 (48.2) | 17,552 (74.8) | 3741 (66.6) | <0.001 |
| 30–39 | 124,470 (26.7) | 40,293 (20.3) | 30,064 (28.9) | 18,525 (36.0) | 29,394 (66.4) | 6197 (57.2) | <0.001 |
| 40–50 | 83,931 (18.0) | 27,065 (13.4) | 18,766 (21.4) | 11,667 (27.4) | 21,847 (60.5) | 4586 (50.1) | <0.001 |
| Region | |||||||
| Northeast | 116,864 (25.1) | 45,312 (31.3) | 16,862 (36.4) | 22,629 (44.5) | 26,243 (75.4) | 5818 (60.1) | <0.001 |
| Central | 72,038 (15.5) | 22,552 (21.5) | 25,908 (37.4) | 11,469 (40.9) | 9406 (69.7) | 2703 (54.9) | <0.001 |
| South | 200,957 (43.2) | 58,688 (20.3) | 59,285 (34.4) | 21,926 (42.2) | 51,318 (71.0) | 9740 (67.7) | <0.001 |
| West | 69,686 (15.0) | 24,493 (20.1) | 18,174 (32.5) | 12,125 (40.2) | 12,316 (63.1) | 2578 (52.5) | <0.001 |
| Unknown | 6168 (1.3) | 1437 (17.5) | 2449 (33.5) | 549 (42.0) | 1314 (65.9) | 419 (68.7) | <0.001 |
| CCI | |||||||
| 0 | 429,346 (92.2) | 140,575 (23.5) | 113,715 (35.3) | 63,410 (42.8) | 92,110 (71.1) | 19,536 (62.0) | <0.001 |
| 1 | 31,505 (6.8) | 10,283 (17.4) | 7876 (31.7) | 4567 (37.5) | 7308 (67.9) | 1471 (58.1) | <0.001 |
| 2 | 4862 (1.0) | 1624 (13.1) | 1087 (28.1) | 721 (34.8) | 1179 (65.2) | 251 (55.2) | <0.001 |
| OR (95% CI) | n/a | 1.0 (Ref) | 1.82 (1.80–1.83) | 2.49 (2.46–2.51) | 8.20 (8.10–8.31) | 5.43 (5.31–5.55) | <0.001 |
| Adjusted† OR (95% CI) | n/a | 1.0 (Ref) | 1.81 (1.79–1.83) | 2.47 (2.44–2.50) | 8.77 (8.66–8.89) | 5.71 (5.58–5.84) | <0.001 |
| OR (95% CI) | n/a | 0.550 (0.545–0.555) | 1.0 (Ref) | 1.37 (1.35–1.38) | 4.51 (4.45–4.57) | 2.99 (2.92–3.06) | <0.001 |
| Adjusted† OR (95% CI) | n/a | 0.552 (0.547–0.557) | 1.0 (Ref) | 1.36 (1.35–1.38) | 4.84 (4.78–4.91) | 3.15 (3.08–3.23) | <0.001 |
Data are n (%) unless otherwise specified, P values for categorical variables were estimated using χ2 tests and the Wald test in the logistic regression models.
*The combined CT/NG group represents a CPT code for either CT or NG, or both.
†Adjusted OR based on age, region, and CCI.
CI indicates confidence interval; n/a, not applicable; OR, odds ratio.
DISCUSSION
This study, involving analysis of data from a national, medical claims database including CPT codes, showed that 49.2% of women with a vaginitis diagnosis did not have any vaginitis testing documented. In addition, only 34% of women with a vaginitis diagnosis were tested for CT/NG, and the testing for CT/NG varied significantly according to vaginitis test type. Our data suggest that most clinicians are not engaging the standard of care for testing and diagnosing vaginitis, or not engaging in comprehensive care by co-testing for vaginitis and CT/NG when patients may be at risk, resulting in missed opportunities for accurate diagnosis and potential associated coinfections.
Our results have important implications for patient management for several reasons. First, the prevalence of treatable STIs is increasing worldwide6,19; it is therefore important to maximize every opportunity to implement STI testing, when appropriate. Recent work demonstrates that women with vaginitis symptoms are at higher risk than other women for 1 or more STIs, and thus, screening should be conducted.7,8 Given that TV is spread through sexual contact and both BV and VVC may be associated with sexual activity,16 a comprehensive care approach would include a thorough assessment of potential risk and/or expanded testing. Accurate diagnosis of all potential pathogens is critical to decrease the risk of adverse health outcomes such as infertility or premature birth and to decrease the risk of acquiring HIV.6
In our analysis, 50% of the women represented in this database did not receive any laboratory-based testing but instead received a vaginitis diagnosis based on clinical presentation without documentation of the use of microscopy, which decreases sensitivity and specificity of diagnosis. A recent study demonstrated that, compared with NAAT-based detection, clinician-based diagnosis of vaginitis with microscopy misses ~42% to 72% of vaginitis cases, depending on the cause,20 which would place the chance of accurate diagnosis within our cohort even lower. Implementation of laboratory-based testing improves sensitivity for detection of vaginitis, with little to no decrease in specificity.
Our results show that a vaginitis diagnosis, which was accompanied by a laboratory test (NAAT or DNA probe), was more often accompanied by co-testing for CT/NG. We found that the frequency of CT/NG testing was higher with CPT codes involving some type of laboratory-based testing. Moreover, CT/NG testing frequency was higher for women receiving NAAT/DNA probe testing, compared with those with traditional laboratory testing (Table 2). The higher rates for CT/NG testing for women receiving NAAT/DNA probe testing could be due to bundled testing for vaginitis and CT/NG. The apparent lack of CT/NG testing associated with no CPT code could be due to inaccurate coding for vaginitis, but more likely is a result of limited access to microscopy or a preference for clinician diagnosis of vaginitis that is based solely on clinical presentation. Consistent with this, previous literature demonstrated a low rate of point-of-care testing (including wet mount microscopy) for women with vaginitis symptoms in community practice settings.16,21 The inconsistent adherence to standard of care for diagnosis of vaginitis is concerning and likely represents missed opportunities for additional STI testing, especially because a large percentage of women with STIs (~85%) also experience coinfection with either BV or Candida species.6,16
The proportion of women across the vaginitis test categories in our cohort, who were 25–29 years of age, was consistently low compared with other age groups. This may have affected the overall picture for CT/NG testing numbers, especially because these STIs typically have a high prevalence within this age group. It is unclear why this age group had a low proportion of cases. One possibility is that individuals may have been dropped by their parents' health care plan at the age of 25 years, resulting in an underrepresentation of women in this age range. However, a review of the 1,920,629 women between the ages of 18 and 50 years did not show a disproportionately high percentage of women in the 25- to 29-year age range being excluded in this analysis. Nevertheless, because the reduced percentage of 25- to 29-year-olds represented in this data set was consistent across all vaginitis test categories, the relative CT/NG values by vaginitis test category should all be affected in a consistent manner.
Limitations
This report included data available in the MarketScan CCE and Medicare supplemental database. Thus, any prior testing, or testing conducted but not billed (such as wet preps), is not captured in the data set. In addition, all testing data here are based on CPT codes and the possibility of undercoding or overcoding must be considered. Using CPT codes to assign diagnoses precludes evaluation of testing efficacy and prior diagnoses made by health departments/STD clinics and not billed to insurance. Absence of the Medicaid database excluded a large pool of individuals who do not receive insurance through their employer. Thus, our analysis was, by default, subject to forms of bias, including selection bias. Although we assume that women sought medical care because of symptoms of vaginitis, it is not possible to know for certain that they were all symptomatic. In addition, it is possible that CT/NG testing could have been coded on a separate visit, which happened to be close to the index visit but was actually not associated with the index visit; this would have introduced bias into the data. There was no detailed information on previous testing or clinical outcomes; it is conceivable, although likely rare, that, in some instances, there was nonindicated CT/NG testing using bundled vaginitis tests. Differences in socioeconomic status could affect both the prevalence of vaginitis causes and CT/NG and could affect the rate of vaginitis and CT/NG testing. Our analysis was limited to the data available in the administrative claims databases, consisting of coding as entered by health care personnel, and important factors such as race, ethnicity, or socioeconomic status22 were not accounted for in our analysis. Although the CCE allows for a large sample size, these factors should be taken into consideration and caution should be used when attempting to generalize these results to the public. However, we believe that this data set provides a representative overview of national testing practices among privately insured patients in the United States. Although outside the scope of this analysis, further study should be conducted to determine missed diagnoses across various population groups based on results with and without co-testing.
CONCLUSIONS
The majority of women diagnosed with a first case of vaginitis in this claims database may not have received any testing to assess for potential causes during the time frame of this analysis. Moreover, because of the high rates of coinfection of TV/BV with CT/NG, this is a missed opportunity to provide comprehensive health care by assessing for additional risk and providing additional screening for CT/NG. Comprehensive care in testing for vaginitis and co-testing for STIs may help to identify CT or NG in women positive for vaginitis, which may otherwise go undetected.6
Footnotes
Acknowledgments: Devin S. Gary, PhD, and Dorsey Mills (both employees of Becton, Dickinson and Company, BD Life Sciences–Integrated Diagnostic Solutions) provided input on the content of this article and editorial assistance. D.S.G. and D.M. have no other potential conflicts of interest.
This work was sponsored by Becton, Dickinson and Company.
Author Contributions: The authors participated on the following aspects of this project: Study concept: C.N.P., M.J., M.W., C.G., N.S., M.B., B.V.D.P.; Study design: C.N.P., M.J., M.W., B.V.D.P.; Data collection and analysis: M.J., M.W., C.G.; Data interpretation: C.N.P., M.J., M.W., C.G., N.S., M.B., B.V.D.P.; Manuscript drafting and revisions: C.N.P., M.J., M.W., C.G., N.S., M.B., B.V.D.P. All authors critically revised the manuscript for important intellectual content, approved the final version to be published, and agree to be accountable for all aspects of the work.
Conflict of Interest and Sources of Funding: M.J., M.W., C.G., N.S. (during the time of study conduct and manuscript preparation), and M.B. are employees of the study sponsor, Becton, Dickinson and Company, BD Life Sciences–Integrated Diagnostic Solutions. C.N.P. reports consulting for Becton, Dickinson and Company, and honorarium received from Roche. B.V.D.P. reports receiving grants to her institution, and honorarium and/or consulting fees from Abbott Molecular; Becton, Dickinson and Company; binx health; BioFire; Cepheid; Hologic; Rheonix; Roche, and SpeeDx.
Presented in part at IDSOG 2021.
Contributor Information
Casey N. Pinto, Email: cpinto@psu.edu.
Molly Jung, Email: molly.jung@bd.com.
Megan Wimmer, Email: megan.wimmer@bd.com.
Claudia Goldblatt, Email: claudia.goldblatt@bd.com.
Nicole Sweeney, Email: nicole.sweeney@tempus.com.
Molly Broache, Email: molly.broache@bd.com.
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