Nucleic Acid Amplification Test Results Research Articles

Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Serologic Testing.

The role of serologic testing for SARS-CoV-2 has evolved during the pandemic as seroprevalence in global populations has increased. The Infectious Diseases Society of America (IDSA) convened an expert panel to perform a systematic review of the coronavirus disease 2019 (COVID-19) serology literature and construct updated best practice guidance related to SARS-CoV-2 serologic testing. This guideline is an update to the fourth in a series of rapid, frequently updated COVID-19 guidelines developed by IDSA. To develop evidence-based recommendations and identify unmet research needs pertaining to the use of anti-SARS-CoV-2 antibody tests for diagnosis, decisions related to vaccination and administration of monoclonal antibodies or convalescent plasma in immunocompromised patients, and identification of a serologic correlate of immunity. A multidisciplinary panel of infectious diseases clinicians, clinical microbiologists and experts in systematic literature reviewed, identified, and prioritized clinical questions related to the use of SARS-CoV-2 serologic tests. Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations. The panel recommends against serologic testing to diagnose SARS-CoV-2 infection in the first two weeks after symptom onset (strong recommendations, low certainty of evidence). Serologic testing should not be used to provide evidence of COVID-19 in symptomatic patients with a high clinical suspicion and repeatedly negative nucleic acid amplification test results (strong recommendation, very low certainty of evidence). Serologic testing may assist with the diagnosis of multisystem inflammatory syndrome in children (strong recommendation, very low certainty of evidence). To seek evidence for prior SARS-CoV-2 infection, the panel suggests testing for IgG, IgG/IgM, or total antibodies to nucleocapsid protein three to five weeks after symptom onset (conditional recommendation, low certainty of evidence). In individuals with previous SARS-CoV-2 infection or vaccination, we suggest against routine serologic testing given no demonstrated benefit to improving patient outcomes (conditional recommendation, very low certainty of evidence.) The panel acknowledges further that a negative spike antibody test may be a useful metric to identify immunocompromised patients who are candidates for immune therapy. The high seroprevalence of antibodies against SARS-CoV-2 worldwide limits the utility of detecting anti-SARS CoV-2 antibody. The certainty of available evidence supporting the use of serology for diagnosis was graded as very low to low. Future studies should use serologic assays calibrated to a common reference standard.

Breath of Health: spectroscopy-based breath test for the detection of SARS-CoV-2

Background Nucleic acid amplification tests (NAAT) are considered the gold standard for COVID-19 diagnosis. These tests require professional manpower and equipment, long processing and swab sampling which is unpleasant to the patients. Several volatile organic compounds (VOCs) have been identified in the breath of COVID-19 patients. Detection of these VOCs using a breath test could help rapidly identify COVID-19 patients. Objective Assess the accuracy of ‘Breath of Health’ (BOH) COVID-19 Fourier-transform infra-red (FTIR) Spectroscopy-based breath test. Methods Breath samples from patients with or without symptoms suggestive for COVID-19 who had NAAT results were collected using Tedlar bags and were blindly analysed using BOH FTIR spectroscopy. BOH Measures several VOCs simultaneously and differentiating positive and negative results. BOH results were compared to NAAT results as gold standard. Results Breath samples from 531 patients were analysed. The sensitivity of BOH breath test was found to be 79.5% and specificity was 87.2%. Positive predictive value (PPV) was 74.7% and negative predictive value (NPV) 90.0%. Calculated accuracy rate was 84.8% and area under the curve 0.834. Subgroup analysis revealed that the NPV of patients without respiratory symptoms was superior over the NPV of symptomatic patients (94.7% vs 80.7%, P-value < 0.0001) and PPV of patients with respiratory symptoms outranks the PPV of individuals without symptoms (85.3% vs 69.2%, P-value 0.0196) Conclusion We found BOH COVID-19 breath test to be a patient-friendly, rapid, non-invasive diagnostic test with high accuracy rate and NPV that could efficiently rule out COVID-19 especially among individuals with low pre-test probability.

691. Association between Clostridioides difficile Colonization, Rectal Swab NAAT Positivity, and Environmental Contamination

Abstract Background Clostridioides difficile (CD) colonization is common among hospitalized patients. Screening for toxigenic CD (TCD) colonization with rectal swab nucleic acid amplification tests (NAAT) may identify people at risk for CDI and help prevent onward TCD transmission, especially in immunocompromised patients with long hospitalizations. The study objective was to test whether rectal swab NAAT could detect TCD colonized patients and whether NAAT results identify patients that contribute to environmental contamination. Methods This was a prospective cohort study on two BMT/Leukemia units. Stool specimens, rectal swabs, and environmental swabs (bedrail, room sink, keyboard) were collected from patients at admission and weekly and cultured semi-quantitatively for TCD. NAAT (Cepheid) was performed on rectal swabs (eSwabs; Copan Diagnostics). The relationship between stool TCD concentration, NAAT Ct, and a positive environmental culture was evaluated using univariate logistic regression. Bleach was used for daily and terminal discharge cleaning of all rooms. Toxigenicity was determined by detection of tcdA or tcdB by whole genome sequencing (WGS). Results From January 2019 - July 2019, 659 stool specimens and 495 rectal swabs were collected from 384 patients. Specimens from 554 patient-days were cultured and 126 (23%) were positive. Of those, 88 (70%) were TCD. 21 of 987 (2%) environmental swabs were TCD positive; 18 (86%) were from bedrails. Among 61 unique patient calendar days with paired rectal swab NAAT and stool culture results (paired samples), overall sensitivity of rectal swab NAAT to detect toxigenic CD colonization compared to culture was 44%, with 4/16 (25%) of people colonized with &amp;gt; 0 - &amp;lt; 10,000 CFU/g of TCD and 7/9 (78%) with ≥ 10,000 CFU/g TCD (Figure 1). There was no relationship between stool culture or rectal swab NAAT result and risk of a positive environmental swab (Figure 2). Figure 1. Toxigenic C. difficile semi-quantitative culture and rectal swab NAAT on paired patient-day of specimen collection (N=61 patient-days) Figure 2. Toxigenic C. difficile semi-quantitative stool and rectal swab NAAT results and environmental contamination by paired patient-day of specimen collection Conclusion Rectal swab NAAT may not be sufficiently sensitive to screen for TCD colonization that contributes to environmental contamination. Disclosures Erik R. Dubberke, MD, MSPH, Abbott: Advisor/Consultant|AstraZeneca: Advisor/Consultant|Ferring Pharmaceuticals: Advisor/Consultant|Ferring Pharmaceuticals: Grant/Research Support|Merck and Co.: Advisor/Consultant|Pfizer: Advisor/Consultant|Pfizer: Grant/Research Support|Seres Therapeutics: Advisor/Consultant|Summit: Advisor/Consultant|Theriva Biologics: Grant/Research Support

Role of Imaging in the Management of Patients with SARS-CoV-2 Lung Involvement Admitted to the Emergency Department: A Systematic Review.

During the waves of the coronavirus disease (COVID-19) pandemic, emergency departments were overflowing with patients suffering with suspected medical or surgical issues. In these settings, healthcare staff should be able to deal with different medical and surgical scenarios while protecting themselves against the risk of contamination. Various strategies were used to overcome the most critical issues and guarantee quick and efficient diagnostic and therapeutic charts. The use of saliva and nasopharyngeal swab Nucleic Acid Amplification Tests (NAAT) in the diagnosis of COVID-19 was one of the most adopted worldwide. However, NAAT results were slow to report and could sometimes create significant delays in patient management, especially during pandemic peaks. On these bases, radiology has played and continues to play an essential role in detecting COVID-19 patients and solving differential diagnosis between different medical conditions. This systematic review aims to summarize the role of radiology in the management of COVID-19 patients admitted to emergency departments by using chest X-rays (CXR), computed tomography (CT), lung ultrasounds (LUS), and artificial intelligence (AI).

High Prevalence of Rectal Chlamydia and Gonorrhea Among Men Who Have Sex With Men Who Do Not Engage in Receptive Anal Sex.

In the United States, annual screening for rectal gonorrhea and chlamydia is only recommended for men who report receptive anal sex (RAS), but other behaviors (e.g., rimming) may lead to rectal Chlamydia trachomatis and Neisseria gonorrhoeae acquisition. We enrolled individuals assigned male sex at birth who reported sex with men and denied RAS in the past 2 years or reported RAS 1 to 2 years ago but were tested and treated since last RAS. Participants enrolled in-person at the Sexual Health Clinic in Seattle, Washington (December 2019-July 2022), or online (July 2021-March 2022). Participants completed a survey that asked about 13 non-RAS behaviors and self-collected a rectal swab for gonorrhea/chlamydia nucleic acid amplification testing. We used log binomial regression to estimate the prevalence of rectal gonorrhea/chlamydia (adjusted prevalence ratio [aPR]) by behavior, adjusting for all other behaviors. We enrolled 292 participants (247 in-person and 45 online); 277 (95%) had nucleic acid amplification testing results. Rectal gonorrhea/chlamydia test positivity was 14.1% overall: 10.5% for rectal chlamydia and 4.3% for rectal gonorrhea. Most participants (70%) reported ≥1 behavior that involved direct contact with their anus. We observed a higher risk of rectal chlamydia for those who did versus did not report perianal play at 12 months (aPR, 2.39; 95% confidence interval, 1.10-5.22) and 2 months (aPR, 2.21; 95% confidence interval, 1.02-4.79). This was the only behavior significantly associated with testing positive. Rectal C. trachomatis and N. gonorrhoeae prevalence was high among men who deny RAS, suggesting other possible routes of acquisition. Rectal screening for those who deny RAS should be made with careful consideration of individual- and population-level effects.

Integrated smart analytics of nucleic acid amplification tests via paper microfluidics and deep learning in cloud computing

Pandemics such as COVID-19 have exposed global inequalities in essential health care. Here, we proposed a novel analytics of nucleic acid amplification tests (NAATs) by combining paper microfluidics with deep learning and cloud computing. Real-time amplifications of synthesized SARS-CoV-2 RNA templates were performed in paper devices. Information pertained to on-chip reactions in time-series format were transmitted to cloud server on which deep learning (DL) models were preloaded for data analysis. DL models enable prediction of NAAT results using partly gathered real-time fluorescence data. Using information provided by the G-channel, accurate prediction can be made as early as 9 min, a 78% reduction from the conventional 40 min mark. Reaction dynamics hidden in amplification curves were effectively leveraged. Positive and negative samples can be unbiasedly and automatically distinguished. Practical utility of the approach was validated by cross-platform study using clinical datasets. Predicted clinical accuracy, sensitivity and specificity were 98.6%, 97.6% and 99.1%. Not only the approach reduced the need for the use of bulky apparatus, but also provided intelligent, distributable and robotic insights for NAAT analysis. It set a novel paradigm for analyzing NAATs, and can be combined with the most cutting-edge technologies in fields of biosensor, artificial intelligence and cloud computing to facilitate fundamental and clinical research.

Clinical outcomes for Clostridioides difficile associated diarrhea in inflammatory bowel disease patients versus non-IBD population: A retrospective cohort study.

Patients with inflammatory bowel disease (IBD) have a higher incidence of Clostridioides difficile infection (CDI). Previous studies have demonstrated negative clinical outcomes in IBD patients with CDI compared to patients without CDI. The clinical presentation of CDI is indistinguishable from IBD exacerbation, thus posing a frequent clinical dilemma on the role of Clostridioides infection in the testing, diagnosis, and treatment of these patients. To compare clinical outcomes of CDI in patients with IBD to those without IBD. Retrospective cohort of adult patients admitted to Rabin Medical Center Israel between the years 2014 and 2020 with a concurrent diagnosis of IBD and CDI. Matching 1:2 was performed between the IBD patients and the non-IBD population with respect to age and sex. Sixty-seven patients with IBD and 134 patients without IBD were included in the study. The groups' median age was 40.6 (interquartile range [IQR] of 29.8-68.9), with 45.8% male and 54.2% female. The non-IBD group had a higher Charlson score with 2 (IQR 0; 5) versus 0 (IQR 0; 4) in the IBD group (P value <.01). Patients with IBD had more exposure to systemic antibiotics, 71.1% versus 26.3% (P value <.01). In a multivariable analysis we found no difference in 90-day mortality and rate of relapse between the 2 study groups with an odds ratio of 1.709 (95% confidence interval 0.321-9.905) and odds ratio of 0.209 (95% confidence interval 0.055-1.513) respectively. In our cohort patients with IBD who present with diarrhea and concomitant CDI have similar rates of relapse and mortality compared with patients without IBD.

Antepartum SARS-CoV-2 infection and adverse birth outcomes in South African women.

SARS-CoV-2 infection in pregnant women has been associated with severe illness in the women and higher rates of premature delivery. There is, however, paucity of data on the impact of the timing of SARS-CoV-2 infection and on symptomatic or asymptomatic infections on birth outcomes. Data from low-middle income settings is also lacking. We conducted a longitudinal study from April 2020 to March 2021, in South Africa, where symptomatic or asymptomatic pregnant women were investigated for SARS-CoV-2 infection during the antepartum period. We aimed to evaluate if there was an association between antepartum SARS-CoV-2 infection on birth outcomes. SARS-CoV-2 infection was investigated by nucleic acid amplification test (NAAT), histological examination was performed in a sub-set of placentas. Overall, 793 women were tested for SARS-CoV-2 antenatally, including 275 (35%) who were symptomatic. SARS-CoV-2 infection was identified in 138 (17%) women, of whom 119 had symptoms (COVID-19 group) and 19 were asymptomatic. The 493 women who were asymptomatic and had a negative SARS-CoV-2 NAAT were used as the referent comparator group for outcomes evaluation. Women with COVID-19 compared with the referent group were 1.66-times (95% confidence interval (CI) = 1.02-2.71) more likely to have a low-birthweight newborn (30% vs 21%) and 3.25-times more likely to deliver a very low-birthweight newborn (5% vs 2%). Similar results for low-birthweight were obtained comparing women with SARS-CoV-2 confirmed infection (30%) with those who had a negative NAAT result (22%) independent of symptoms presentation. The placentas from women with antenatal SARS-CoV-2 infection had higher percentage of chorangiosis (odds ratio (OR) = 3.40, 95% CI = 1.18-.84), while maternal vascular malperfusion was more frequently identified in women who tested negative for SARS-CoV-2 (aOR = 0.28, 95% CI = 0.09-0.89). Our study demonstrates that in a setting with high HIV infection prevalence and other comorbidities antenatal SARS-CoV-2 infection was associated with low-birthweight delivery.

Presumptive and Follow-Up Treatment Associated With Gonorrhea and Chlamydia Testing Episodes in Sexually Transmitted Disease Clinics: Impact of Changing Treatment Guidelines for Gonorrhea, Sexually Transmitted Disease Surveillance Network, 2015-2018.

Background Centers for Disease Control and Prevention recommendation for treatment of uncomplicated gonorrhea (NG) were revised in December 2020 and include ceftriaxone monotherapy when chlamydial infection was excluded. We evaluated the impact of these revised treatment recommendations using data from a network of sexually transmitted disease (STD) clinics before the change in guidelines. Methods We performed a cross-sectional analysis from 8 STD clinics participating in the STD Surveillance Network from January 2015 to June 2018 assessing NG/chlamydia (CT) testing episodes, nucleic acid amplification test results, CT only and NG/CT treatment records, and timing of treatment. We describe the frequency of NG and CT treatment practices and what proportion of patients treated would not have had to receive an antichlamydial agent. Results Of 190,589 episodes that occurred during the study period, 67,895 (35.6%) episodes were associated with a treatment record consistent with NG or chlamydia (CT only [n = 37,530] or NG/CT [n = 30,365]), most (~86%) were prescribed on the same-day as initial testing. Of the 67,895 episodes with corresponding treatment record(s), 42.1% were positive for either NG or CT compared with 3.7% were positive for NG or CT for those not associated with treatment records (n = 122,694 episodes). Among 30,365 episodes associated with NG/CT treatment records, monotherapy would only have been indicated for 10.1% (3081/30,365) of the episodes as they were treated on follow-up and were NG positive and CT negative. Conclusions Treatment was prescribed in one-third of NG/CT testing episodes, with the majority provided same day. Despite changes in NG treatment guidelines to ceftriaxone monotherapy, majority of patients would continue to receive an antichlamydia agent when treated for NG in these settings.

Clinical practice of rapid antigen tests for SARS-CoV-2 Omicron variant: A single-center study in China.

Responding to the fast-spreading SARS-CoV-2 Omicron variant, to improve screening efficiency, rapid antigen tests (RATs) were first added as a supplementary detection method in China in mid-March, 2022. What and how big a role RATs should play need to be supported by clinical data. Here, RAT performance and relevant factors in comparison with nucleic acid amplification tests (NAATs) were assessed in Omicron-infected inpatients. From the NAAT results, nasopharyngeal swabs (NPs) performed better than oropharyngeal swabs (OPs). RATs tested on NAAT positive NPs performed better than those with OP-positive samples. The RAT positivity rate was strongly associated with high levels of N and OFR1ab genes, especially in NPs where patients also had significantly longer hospital stays and shorter days from symptom onset to RAT testing. Self-performed RATs had a detection accuracy that was comparable to professionally performed RATs when the subjects were well guided. The antigen negative rate of the studied patients was 100% at discharge. These findings suggest that, in addition to a supplementary detection role, RATs can be an important strategy for evaluating the disease progression of Omicron-infected inpatients. This study provides important clinical data to support better rules regarding RATs under China's COVID-19 prevention and control policy.

Assessment of performance characteristics of COVID-19 ICD-10-CM diagnosis code U07.1 using SARS-CoV-2 nucleic acid amplification test results.

The Food and Drug Administration’s Biologics Effectiveness and Safety Initiative conducts active surveillance to protect public health during the coronavirus disease 2019 (COVID-19) pandemic. This study evaluated performance of International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis code U07.1 in identifying COVID-19 cases in claims compared with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid amplification test results in linked electronic health records (EHRs). Care episodes in three populations were defined using COVID-19-related diagnoses (population 1), SARS-CoV-2 nucleic acid amplification test procedures (population 2), and all-cause hospitalizations (population 3) in two linked claims-EHR databases: IBM® MarketScan® Explorys® Claims-EMR Data Set (commercial) and OneFlorida Data Trust linked Medicaid-EHR. Positive and negative predictive values were calculated. Respectively, populations 1, 2, and 3 included 26,686, 26,095, and 2,564 episodes (commercial) and 29,117, 23,412, and 9,629 episodes (Florida Medicaid). The positive predictive value was >80% and the negative predictive value was >95% in each population, with the highest positive predictive value in population 3 (commercial: 91.9%; Medicaid: 93.1%). Findings did not vary substantially by patient age. Positive predictive values in populations 1 and 2 fluctuated during April–June 2020. They then stabilized in the commercial but not the Medicaid population. Negative predictive values were consistent over time in all populations and databases. Our findings indicate that U07.1 has high performance in identifying COVID-19 cases and noncases in claims databases. Performance may vary across populations and periods.

Earlier detection of SARS-CoV-2 infection by blood RNA signature microfluidics assay.

Earlier detection of SARS-CoV-2 infection by blood RNA signature microfluidics assay.

Characterization of test positivity among patients with coronavirus disease 2019 (COVID-19) in three electronic health records databases, February–November 2020

BackgroundMonitoring COVID-19 testing volumes and test positivity is an integral part of the response to the pandemic. We described the characteristics of individuals who were tested and tested positive for SARS-CoV-2 during the pre-vaccine phase of the pandemic in the United States (U.S.).MethodsThis descriptive study analyzed three U.S. electronic health record (EHR) databases (Explorys, Academic Health System, and OneFlorida) between February and November 2020, identifying patients who received an interpretable nucleic acid amplification test (NAAT) result. Test-level data were used to characterize the settings in which tests were administered. Patient-level data were used to calculate test positivity rates and characterize the demographics, comorbidities, and hospitalization rates of COVID-19-positive patients.ResultsOver 40% of tests were conducted in outpatient care settings, with a median time between test order and result of 0–1 day for most settings. Patients tested were mostly female (55.6–57.7%), 18–44 years of age (33.9–41.2%), and Caucasian (44.0–66.7%). The overall test positivity rate was 13.0% in Explorys, 8.0% in Academic Health System, and 8.9% in OneFlorida. The proportion of patients hospitalized within 14 days of a positive COVID-19 NAAT result was 24.2–33.1% across databases, with patients over 75 years demonstrating the highest hospitalization rates (46.7–69.7% of positive tests).ConclusionsThis analysis of COVID-19 testing volume and positivity patterns across three large EHR databases provides insight into the characteristics of COVID-19-tested, COVID-19-test-positive, and hospitalized COVID-19-test-positive patients during the early phase of the pandemic in the U.S.

Doxycycline versus azithromycin for the treatment of anorectal Chlamydia trachomatis infection in women concurrent with vaginal infection (CHLAZIDOXY study): a multicentre, open-label, randomised, controlled, superiority trial

Anorectal infections with Chlamydia trachomatis are commonly found in women. Although the efficacy of doxycycline and azithromycin is comparable in the treatment of urogenital infection, their efficacies toward anorectal infection remain unclear. We therefore aimed to compare a single dose of azithromycin with a 7-day course of doxycycline for the treatment of anorectal C trachomatis infection in women with concurrent vaginal infection. We did a multicentre, open-label, randomised, controlled, superiority trial involving four sexually transmitted infection screening centres and three pregnancy termination centres in France. We included sexually active adult women (≥18 years) with a positive C trachomatis vaginal swab who agreed to provide self-collected anorectal swabs for C trachomatis detection. Participants were randomly assigned (1:1), using block sizes of six and eight and stratification by each investigating centre, to orally receive either azithromycin (a single 1-g dose, with or without food) or doxycycline (100 mg in the morning and evening at mealtimes for 7 days [ie, 100 mg of doxycycline twice per day for 7 days]). All laboratory staff who did the bacteriological analyses, but not the participants and the investigators, were masked to the treatment groups. The primary outcome was the microbiological anorectal cure rate defined as a C trachomatis-negative nucleic acid amplification test (NAAT) result in anorectal specimens 6 weeks after treatment initiation among women who had a baseline C trachomatis-positive anorectal NAAT result. The primary analysis was done in the modified intention-to-treat population, with multiple imputation, which included all women who underwent randomisation and had a C trachomatis-positive vaginal and anorectal NAAT result at baseline. Adverse events were reported in all women who underwent randomisation. This study is registered with ClinicalTrials.gov, number NCT03532464. Between Oct 19, 2018, and April 17, 2020, we randomly assigned a total of 460 participants to either the doxycycline group (n=230) or the azithromycin group (n=230). Four (1%) of 460 participants were excluded because they refused to take doxycycline or were found to be ineligible after randomisation. Among the 456 participants, 357 (78%) had a concurrent C trachomatis-positive anorectal NAAT result at baseline; 184 (52%) of 357 were in the doxycycline group and 173 (48%) were in the azithromycin group (ie, the modified intention-to-treat population). Microbiological anorectal cure occurred in 147 (94%) of 156 participants in the doxycycline group (28 missing values) versus 120 (85%) of 142 in the azithromycin group (31 missing values; adjusted odds ratio with imputation of missing values 0·43 [95% CI 0·21-0·91]; p=0·0274). Reported adverse events possibly related to treatment were notified in 53 (12%) of 456 women: 24 (11%) of 228 in the doxycycline group and 29 (13%) of 228 in the azithromycin group. Gastrointestinal disorders were the most frequently occurring, in 43 (9%) of 456 women: 17 (8%) of 228 in the doxycycline group and 26 (11%) of 228 in the azithromycin group. The microbiological anorectal cure rate was significantly lower among women who received a single dose of azithromycin than among those who received a 1-week course of doxycycline. This finding suggests that doxycycline should be the first-line therapy for C trachomatis infection in women. French Ministry of Health. For the French translation of the abstract see Supplementary Materials section.

Rapid molecular tests for tuberculosis and tuberculosis drug resistance: a qualitative evidence synthesis of recipient and provider views.

Rapid molecular tests for tuberculosis and tuberculosis drug resistance: a qualitative evidence synthesis of recipient and provider views.

Pre-endoscopy coronavirus disease 2019 screening and severe acute respiratory syndrome coronavirus-2 nucleic acid amplification testing in the Veterans Affairs healthcare system: clinical practice patterns, outcomes, and relationship to procedure volume

Background and AimsThe coronavirus disease 2019 (COVID-19) pandemic has had profound impacts worldwide, including on the performance of GI endoscopy. We aimed to describe the performance and outcomes of pre-endoscopy COVID-19 symptom and exposure screening and severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) nucleic acid amplification testing (NAAT) across the national Veterans Affairs healthcare system and describe the relationship of SARS-CoV-2 NAAT use and resumption of endoscopy services.MethodsCOVID-19 screening and NAAT results from March 2020 to April 2021 were analyzed to determine use, performance characteristics of screening, and association between testing and endoscopic volume trends.ResultsOf 220,891 completed endoscopies identified, 115,890 (52.5%) had documented preprocedure COVID-19 symptom and exposure screenings and 154,127 (69.8%) had preprocedure NAAT results within 7 days before scheduled endoscopy. Of 131,894 total canceled endoscopies, 26,475 (20.1%) had screening data and 28,505 (21.6%) had SARS-CoV-2 NAAT results. Overall, positive NAAT results were reported in 1.8% of all individuals tested and in 1.3% of those who screened negative. Among completed and canceled endoscopies, COVID-19 screening had a 34.6% sensitivity (95% confidence interval [CI], 32.4%-36.8%) and 96.4% specificity (95% CI, 96.2%-96.5%) when compared with NAAT. COVID-19 screening had a positive predictive value of 15.0% (95% CI, 14.0%-16.1%) and a negative predictive value of 98.7% (95% CI, 98.7%-98.8%). There was a very weak correlation between monthly testing and monthly endoscopy volume by site (Spearman rank correlation coefficient = .09).ConclusionsThese findings have important implications for decisions about preprocedure testing, especially given breakthrough infections among vaccinated individuals during the SARS-CoV-2 delta and omicron variant surge.

Effectiveness of COVID-19 mRNA Vaccination in Preventing COVID-19-Associated Hospitalization Among Adults with Previous SARS-CoV-2 Infection - United States, June 2021-February 2022.

Previous infection with SARS-CoV-2, the virus that causes COVID-19, has been estimated to confer up to 90% protection against reinfection, although this protection was lower against the Omicron variant compared with that against other SARS-CoV-2 variants (1-3). A test-negative design was used to estimate effectiveness of COVID-19 mRNA vaccines in preventing subsequent COVID-19-associated hospitalization among adults aged ≥18 years with a previous positive nucleic acid amplification test (NAAT) or diagnosis of COVID-19.† The analysis used data from Cosmos, an electronic health record (EHR)-aggregated data set (4), and compared vaccination status of 3,761 case-patients (positive NAAT result associated with hospitalization) with 7,522 matched control-patients (negative NAAT result). After previous SARS-CoV-2 infection, estimated vaccine effectiveness (VE) against COVID-19-associated hospitalization was 47.5% (95% CI=38.8%-54.9%) after 2 vaccine doses and 57.8% (95% CI=32.1%-73.8%) after a booster dose during the Delta-predominant period (June 20-December 18, 2021), and 34.6% (95% CI=25.5%-42.5%) after 2 doses and 67.6% (95% CI=61.4%-72.8%) after a booster dose during the Omicron-predominant period (December 19, 2021-February 24, 2022). Vaccination provides protection against COVID-19-associated hospitalization among adults with previous SARS-CoV-2 infection, with the highest level of protection conferred by a booster dose. All eligible persons, including those with previous SARS-CoV-2 infection, should stay up to date with vaccination to prevent COVID-19-associated hospitalization.

2019 British Association of Sexual Health and HIV National Clinical Audit of timelines to be seen, test results and treatment for Chlamydia trachomatis

BASHH/MEDFASH (Medical Foundation for HIV and Sexual Health) Standards for the Management of Sexual Health Services 20141 set out a number of recommendations regarding time between contacting a service to being seen, time to receiving results, and time to treatment. This audit investigated if UK practice is compliant with BASHH standards of care in terms of: Time to patient being seen after contacting sexual health services, time to chlamydia (CT) NAAT (nucleic acid amplification test) results and time from positive CT result to treatment. All UK level 2 (non-specialist) and level 3 (specialist) sexual health clinics were invited to take part. Data were collected via a survey of sexual health clinics and a retrospective case-note review of the last 40 people aged 16 or over per service seen with chlamydia but not syphilis or gonorrhoea. Cases were identified using the SHHAPT (Sexual Health and HIV Activity Types) National STI Surveillance code for chlamydia (C4). There were responses from 221 sites. 67% of sites reported offering both appointment and walk-in access, 26.2% appointment-only, 6.8% walk-in only. The mean turn-away rate of individuals seeking walk-in access on the last open day was 6.1%. There were variations in local service specification turnaround times for chlamydia nucleic acid amplification test results; 32% of sites reported no specified turnaround time. Case note audit of individuals seen with chlamydia showed 74.1% of individuals were tested for chlamydia at a level 3 clinic, 11.8% at a level 2 sexual health clinic, 7.3% used a self-sampling kit requested online and 3.9% tested at a different setting. 92.1% of individuals who initially tested at a sexual health service had an attempted notification within 10 working days of a positive chlamydia test. 95% of individuals were treated within a sexual health service. Overall, 94.0% of individuals were treated within 15 working days of the test result. When missing data were excluded, patient initiated GUM/level 3 attenders seen within 2 working days met the audit standard as did patient access to results within 10-working days for those whose initial CT NAAT sample was taken at a GUM/level 3 clinic and treatment within 3 weeks for GUM/level 3 attenders. Patients offered to be seen/assessed within 2 working days and lab report within 5 working days did not meet the audit standard. Recommendations include ensuring that laboratory turn-around times are included in contracts or service level agreements for clinical services, and local monitoring of these. Dates when individuals first seek to access sexual health services should also be recorded and used to monitor performance in comparison with access standards.

Degradation of SARS-CoV-2 specific ribonucleic acid in samples for nucleic acid amplification detection

The degradation of SARS-CoV-2 specific ribonucleic acid (RNA) was investigated by a numerical modeling approach based on nucleic acid amplification test (NAAT) results utilizing the SmartAmp technique. The precision of the measurement was verified by the relative standard deviation (RSD) of repeated measurements at each calibration point. The precision and detection limits were found to be 6% RSD (seven repeated measurements) and 94 copies/tube, respectively, at the lowest calibration point. RNA degradation curves obtained from NAAT data on four different temperatures were in good agreement with the first-order reaction model. By referring to rate constants derived from the results, the Arrhenius model was applied to predict RNA degradation behavior. If the initial RNA concentration was high enough, such as in samples taken from infected bodies, the NAAT results were expected to be positive during testing. On the other hand, if initial RNA concentrations were relatively low, such as RNA in residual viruses on environmental surfaces, special attention should be paid to avoid false-negative results. The results obtained in this study provide a practical guide for RNA sample management in the NAAT of non-human samples.

Characterizing the COVID-19 Illness Experience to Inform the Study of Post-acute Sequelae and Recovery.

BackgroundThere is an urgent need to fully understand the impact of variable COVID-19 experiences and the optimal management of post-acute sequelae of SARS-CoV-2 infection. We characterized the variability in the acute illness experience and ongoing recovery process from participants in a COVID-19 recovery cohort study in Northern California in 2020.MethodWe completed 24 semi-structured in-depth interviews with adults with confirmed positive SARV-CoV-2 nucleic acid amplification test result, had recovered or were recovering from acute infection, and underwent serial evaluations. We purposefully sampled English- and Spanish-speaking adults with asymptomatic, mild, and severe symptomatic infection, including those who were hospitalized and those with HIV co-infection. We used a thematic analysis to analyze interviews and identify salient themes.ResultsAfter integrating the thematic analysis with clinical data, we identified key themes: (1) across symptom profiles and severity, experiencing COVID-19 was associated with psychological distress; (2) symptomatic infection carried uncertainty in symptom presentation and ongoing recovery (e.g., long COVID); and (3) health information-seeking behavior was facilitated by access to medical care and uncertainty with the recovery process.ConclusionOur data informs the emerging field of “long COVID” research and shows a need to provide information and continuous support to persons with post-acute sequelae to ensure they feel secure along the path to recovery.