Elapsed time since BNT162b2 vaccine and risk of SARS-CoV-2 infection: test negative design study

Abstract Objectives To determine whether time elapsed since the second injection of the Pfizer-BioNTech BNT162b2 mRNA vaccine was significantly associated with the risk of covid-19 infection after vaccination in people who received two vaccine injections. Design Test negative design study. Setting Electronic health records of a large state mandated healthcare organisation, Israel. Participants Adults aged ≥18 years who had received a reverse transcription polymerase chain reaction (RT-PCR) test between 15 May 2021 and 17 September 2021, at least three weeks after their second vaccine injection, had not received a third vaccine injection, and had no history of covid-19 infection. Main outcome measures Positive result for the RT-PCR test. Individuals who tested positive for SARS-CoV-2 and controls were matched for week of testing, age category, and demographic group (ultra-orthodox Jews, individuals of Arab ancestry, and the general population). Conditional logistic regression was adjusted for age, sex, socioeconomic status, and comorbid conditions. Results 83 057 adults received an RT-PCR test for SARS-CoV-2 during the study period and 9.6% had a positive result. Time elapsed since the vaccine injection was significantly longer in individuals who tested positive (P<0.001). Adjusted odds ratio for infection at time intervals >90 days since vaccination were significantly increased compared with the reference of <90 days: 2.37 (95% confidence interval 1.67 to 3.36) for 90-119 days, 2.66 (1.94 to 3.66) for 120-149 days, 2.82 (2.07 to 3.84) for 150-179 days, and 2.82 (2.07 to 3.85) for ≥180 days (P<0.001 for each 30 day interval). Conclusions In this large population of adults tested for SARS-CoV-2 by RT-PCR after two doses of mRNA BNT162b2 vaccine, a gradual increase in the risk of infection was seen for individuals who received their second vaccine dose after at least 90 days.

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Elapsed time since BNT162b2 vaccine and risk of SARS-CoV-2 infection in a large cohort

10.1101/2021.08.03.21261496 ◽

2021 ◽

Author(s):

Ariel Israel ◽

Eugene Merzon ◽

Alejandro A Schäffer ◽

Yotam Shenhar ◽

Ilan Green ◽

...

Keyword(s):

Messenger Rna ◽

Large Scale ◽

Health Care Organization ◽

Vaccination Campaign ◽

Large Population ◽

Vaccine Dose ◽

Care Organization ◽

Test Results ◽

Rt Pcr ◽

Pcr Test

Importance: Israel was among the first countries to launch a large-scale COVID-19 vaccination campaign, and quickly vaccinated its population, achieving early control over the spread of the virus. However, the number of COVID-19 cases is now rapidly increasing, which may indicate that vaccine protection decreases over time. Objective: To determine whether time elapsed since the second BNT162b2 messenger RNA (mRNA) vaccine (Pfizer-BioNTech) injection is significantly associated with the risk of post-vaccination COVID-19 infection. Design: This is a retrospective cohort study performed in a large state-mandated health care organization in Israel. Participants: All fully vaccinated adults who have received a RT-PCR test between May 15, 2021 and July 26, 2021, at least two weeks after their second vaccine injection were included. Patients with a history of past COVID-19 infection were excluded. Main Outcome and Measure: Positive result for the RT-PCR test. Results: The cohort included 33,993 fully vaccinated adults, 49% women, with a mean age of 47 years (SD, 17 years), who received an RT-PCR test for SARS-CoV-2 during the study period. The median time between the second dose of the vaccine and the RT-PCR test was 146 days, interquartile range [121-167] days. 608 (1.8%) patients had positive test results. There was a significantly higher rate of positive results among patients who received their second vaccine dose at least 146 days before the RT-PCR test compared to patients who have received their vaccine less than 146 days before: odds ratio for infection was 3.00 for patients aged over 60 (95% CI 1.86-5.11); 2.29 for patients aged between 40 and 59 (95% CI 1.67-3.17); and 1.74 for patients aged between 18 and 39 (95% CI 1.27-2.37); P<0.001 in each age group. Conclusions and Relevance: In this large population study of patients tested for SARS-CoV-2 by RT-PCR following two doses of mRNA BNT162b2 vaccine, we observe a significant increase of the risk of infection in individuals who received their last vaccine dose since at least 146 days ago, particularly among patients older than 60.

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COVID-19 and Pneumocystis jirovecii Pulmonary Coinfection—The First Case Confirmed through Autopsy

Medicina ◽

10.3390/medicina57040302 ◽

2021 ◽

Vol 57 (4) ◽

pp. 302

Author(s):

Ionuț Isaia Jeican ◽

Patricia Inișca ◽

Dan Gheban ◽

Flaviu Tăbăran ◽

Maria Aluaș ◽

...

Keyword(s):

Emergency Department ◽

Positive Result ◽

Histopathological Examination ◽

Adrenal Hemorrhage ◽

Rt Pcr ◽

Case Presentation ◽

First Case ◽

Bilateral Adrenal Hemorrhage ◽

The Moment ◽

Pcr Test

Background: Establishing the diagnosis of COVID-19 and Pneumocystisjirovecii pulmonary coinfection is difficult due to clinical and radiological similarities that exist between the two disorders. For the moment, fungal coinfections are underestimated in COVID-19 patients. Case presentation: We report the case of a 52-year-old male patient, who presented to the emergency department for severe dyspnea and died 17 h later. The RT-PCR test performed at his admission was negative for SARS-CoV-2. Retesting of lung fragments collected during autopsy revealed a positive result for SARS-CoV-2. Histopathological examination showed preexisting lesions, due to comorbidities, as well as recent lesions: massive lung thromboses, alveolar exudate rich in foam cells, suprapleural and intra-alveolar Pneumocystisjirovecii cystic forms, and bilateral adrenal hemorrhage. Conclusion: COVID-19 and P.jirovecii coinfection should be considered, particularly in critically ill patients, and we recommend the systematic search for P. jirovecii in respiratory samples.

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Superiority of MALDI-TOF Mass Spectrometry over Real-Time PCR for SARS-CoV-2 RNA Detection

Viruses ◽

10.3390/v13050730 ◽

2021 ◽

Vol 13 (5) ◽

pp. 730

Author(s):

Magda Rybicka ◽

Ewa Miłosz ◽

Krzysztof Piotr Bielawski

Keyword(s):

Mass Spectrometry ◽

Gold Standard ◽

Viral Genome ◽

False Negative ◽

Rt Pcr ◽

Rna Detection ◽

Maldi Tof ◽

Negative Results ◽

False Negative Results ◽

Pcr Test

At present, the RT-PCR test remains the gold standard for early diagnosis of SARS-CoV-2. Nevertheless, there is growing evidence demonstrating that this technique may generate false-negative results. Here, we aimed to compare the new mass spectrometry-based assay MassARRAY® SARS-CoV-2 Panel with the RT-PCR diagnostic test approved for clinical use. The study group consisted of 168 suspected patients with symptoms of a respiratory infection. After simultaneous analysis by RT-PCR and mass spectrometry methods, we obtained discordant results for 17 samples (10.12%). Within fifteen samples officially reported as presumptive positive, 13 were positive according to the MS-based assay. Moreover, four samples reported by the officially approved RT-PCR as negative were positive in at least one MS assay. We have successfully demonstrated superior sensitivity of the MS-based assay in SARS-CoV-2 detection, showing that MALDI-TOF MS seems to be ideal for the detection as well as discrimination of mutations within the viral genome.

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The role of CT imaging for management of COVID-19 in epidemic area: early experience from a University Hospital

Insights into Imaging ◽

10.1186/s13244-020-00957-5 ◽

2021 ◽

Vol 12 (1) ◽

Author(s):

Vikram rao Bollineni ◽

Koenraad Hans Nieboer ◽

Seema Döring ◽

Nico Buls ◽

Johan de Mey

Keyword(s):

Ct Scan ◽

Predictive Value ◽

Ct Imaging ◽

Chest Ct ◽

University Hospital ◽

Rt Pcr ◽

Ct Findings ◽

Epidemic Area ◽

Chest Ct Scan ◽

Pcr Test

Abstract Background To evaluate the clinical value of the chest CT scan compared to the reference standard real-time polymerase chain reaction (RT-PCR) in COVID-19 patients. Methods From March 29th to April 15th of 2020, a total of 240 patients with respiratory distress underwent both a low-dose chest CT scan and RT-PCR tests. The performance of chest CT in diagnosing COVID-19 was assessed with reference to the RT-PCR result. Two board-certified radiologists (mean 24 years of experience chest CT), blinded for the RT-PCR result, reviewed all scans and decided positive or negative chest CT findings by consensus. Results Out of 240 patients, 60% (144/240) had positive RT-PCR results and 89% (213/240) had a positive chest CT scans. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of chest CT in suggesting COVID-19 were 100% (95% CI: 97–100%, 144/240), 28% (95% CI: 19–38%, 27/240), 68% (95% CI: 65–70%) and 100%, respectively. The diagnostic accuracy of the chest CT suggesting COVID-19 was 71% (95% CI: 65–77%). Thirty-three patients with positive chest CT scan and negative RT-PCR test at baseline underwent repeat RT-PCR assay. In this subgroup, 21.2% (7/33) cases became RT-PCR positive. Conclusion Chest CT imaging has high sensitivity and high NPV for diagnosing COVID-19 and can be considered as an alternative primary screening tool for COVID-19 in epidemic areas. In addition, a negative RT-PCR test, but positive CT findings can still be suggestive of COVID-19 infection.

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Delayed pulmonary embolism after COVID-19 pneumonia: a case report

European Heart Journal - Case Reports ◽

10.1093/ehjcr/ytaa449 ◽

2020 ◽

Author(s):

Mohamad Kanso ◽

Thomas Cardi ◽

Halim Marzak ◽

Alexandre Schatz ◽

Loïc Faucher ◽

...

Keyword(s):

Risk Factors ◽

Intensive Care Unit ◽

Pulmonary Embolism ◽

Acute Pulmonary Embolism ◽

Index Hospitalization ◽

Rt Pcr ◽

Moderate Severity ◽

Respiratory Status ◽

Case Summary ◽

Pcr Test

Abstract Background Since the onset of the COVID-19 pandemic, several cardiovascular manifestations have been described. Among them, venous thromboembolism (VTE) seems to be one of the most frequent, particularly in intensive care unit patients. We report two cases of COVID-19 patients developing acute pulmonary embolism (PE) after discharge from a first hospitalization for pneumonia of moderate severity. Case summary Two patients with positive RT-PCR test were initially hospitalized for non-severe COVID-19. Both received standard thromboprophylaxis during the index hospitalization and had no strong predisposing risk factors for VTE. Few days after discharge, they were both readmitted for worsening dyspnoea due to PE. One patient was positive for lupus anticoagulant. Discussion Worsening respiratory status in COVID-19 patients must encourage physicians to search for PE since SARS-CoV-2 infection may act as a precipitant risk factor for VTE. Patients may thus require more aggressive and longer thromboprophylaxis after COVID-19 related hospitalization.

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Death and COVID-19 Anxiety in Home-Quarantined Individuals Aged 65 and Over During the Pandemic

OMEGA - Journal of Death and Dying ◽

10.1177/00302228211059894 ◽

2021 ◽

pp. 003022282110598

Author(s):

Hümeyra Aslaner ◽

Betül Özen ◽

Zeliha K. Erten ◽

Mebrure Beyza Gökçek

Keyword(s):

Polymerase Chain Reaction ◽

Death Anxiety ◽

Short Form ◽

Anxiety Score ◽

Test Results ◽

Rt Pcr ◽

Chain Reaction ◽

Polymerase Chain ◽

Test Result ◽

Pcr Test

Urgent measures were taken for those at the age of 65 and over who were at the risk group all over the world due to the COVID-19 pandemic. It is known that many individuals at the age of 65 and over have experienced anxiety due to the uncertainties. This study aimed to determine the anxiety and death anxiety in individuals aged 65 and over who were isolation at home due to being diagnosed with COVID-19 or being in contact during the pandemic process. The study is descriptive and cross-sectional. It was performed with 656 home-quarantined individuals aged between 65–80 years with positive or negative real-time polymerase chain reaction (RT-PCR) test result. A form including questions about the death anxiety and the Coronavirus Anxiety Scale Short Form prepared by the researchers were administered to the individuals by phone call. Of the participants, 49.5% were male. Median COVID-19 anxiety score was 4 (0–18). Anxiety scores of the male and female participants were similar. Participants with negative polymerase chain reaction (PCR) results and those with death anxiety had higher COVID anxiety scores. Death anxiety has increased by 1.661 times in male gender, 1.983 times in RT-PCR positivity and 0.146 times in the presence of symptoms. Individuals with positive COVID-19 test results or those aged 65 and over who had death anxiety and negative COVID-19 test result but who were in home-isolation due to being a contact had higher anxiety score. For this reason, those with death anxiety can be supported in line with their religious beliefs to reduce anxiety. Those with negative PCR test results in quarantine can be adequately informed about the COVID-19.

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Accuracy of Computed Tomography for Detection of COVID-19 among Suspected Patients

10.53350/pjmhs211592474 ◽

2021 ◽

Vol 15 (9) ◽

pp. 2474-2476

Author(s):

Maham Munir Awan ◽

Afshan Noreen ◽

Farah Kalsoom ◽

Muhammad Tahir ◽

Umaima Majeed ◽

...

Keyword(s):

Computed Tomography ◽

Predictive Value ◽

Gold Standard ◽

Radiology Department ◽

True Positive ◽

Test Results ◽

Rt Pcr ◽

Radiological Society ◽

Medical University ◽

Pcr Test

Objective: To determine the accuracy of CT chest in diagnosis of COVID-19 taking RT-PCR-testing as gold standard. Materials and Methods: A total of 150 patients of suspicion of COVID-19 who were referred for CT Chest in Radiology Department of Nishtar Medical University Multan from June-2020 to May-2021 were included. In all patients, two RT-PCR test results were obtained with 7 days of admission in hospital. Presence of any of these positive was labelled as COVID-19 infection. CT chest was performed in all patients within 2 days of admission in hospital using 128 slices CT scan machine. The diagnosis of COVID-19 infection was made according to the recommendations by Radiological Society of North America (RSNA) protocol. Results: Mean age was 51.3±14.7 years. 78 (52%) patients were male and 72 (48%) patients were female. RTPCR test was positive in 89 (59.3%) patients. While the CT chest findings were suggestive of COVID-19 infection in 130 (86.7%) patients. The sensitivity of CT chest was 95.5%, specificity 26.2%, PPV wad 65.4% and NPV was 80.0%. Conclusion: CT chest has a very good sensitivity for detection of COVID-19, it can be used as a rapid diagnostic tool especially in areas of pandemic. However, the specificity of CT chest is low, that can limit its use in low COVID-19 affected areas. Keywords: COVID-19, Computed tomography, False Positive, True Positive, Positive Predictive Value, Negative Predictive Value.

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DIAGNOSTIC ROLE OF CHEST CT USING CO-RADS CATEGORIZATION IN SARS-COV-2 INFECTION WITH EMPHASIS ON IMPACT OF CT IN PATIENTS WITH DELAYED OR NEGATIVE INITIAL RTPCR TEST

10.36106/ijar/9301921 ◽

2021 ◽

pp. 51-52

Author(s):

Tharani Putta ◽

Kaushik Deconda

Keyword(s):

Diagnostic Performance ◽

Virus Disease ◽

Vital Role ◽

Chest Ct ◽

Lung Involvement ◽

Test Results ◽

Rt Pcr ◽

Diagnostic Role ◽

Pcr Test

BACKGROUND AND OBJECTIVE: Role of chest CT in diagnosis of corona virus disease 2019 (COVID-19) has been controversial. The purpose of this study is to evaluate the diagnostic performance of chest CT when utilizing COVID-19 Reporting and Data System (CO-RADS). METHODOLOGY: Retrospective study including consecutive patients with positive SARS-CoV-2 RT-PCR test (initial or repeat test) and chest CT done in our institute between June and September 2020. Spectrum of CT ndings, CO-RADS score and 25 point CT severity score (CTSS) were recorded. RESULTS: A total of 300 consecutive patients with SARS-CoV-2 infection were included in the analysis. Out of the 168 patients who underwent CT prior to positive RT-PCR result, 125 (74.4%) had CO-RADS 3, 4 or 5 score on chest CT. 32 study patients (10.6%) had initial negative RT-PCR of which 24 (75%) had CO-RADS 4 or 5 score. Of the total patients with CO-RADS 3 to 5 score (227), 20 (8.8%) had severe lung involvement (CTSS 18-25), 83 (36.6%) had moderate lung involvement (CTSS 8-17) and 124 (54.6%) had mild lung involvement (CTSS 1-7). The mean CTSS was 7.9 with mean lobar score being higher in lower lobes (RLL=1.82, LLL=1.78) compared to the upper and middle lobes (RUL=1.61, RML=1.19, LUL=1.53). CONCLUSION:CT using CO-RADS scoring system has good diagnostic performance. In addition to assessing disease severity, it plays a vital role in triage of patients with suspected COVID-19 especially when there is limited availability of SARS-CoV-2 RT-PCR tests, delay in RT-PCR test results or in negative RT-PCR cases when there is high index of clinical suspicion.

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Effectiveness of CoronaVac, ChAdOx1, BNT162b2 and Ad26.COV2.S among individuals with prior SARS-CoV-2 infection in Brazil

10.1101/2021.12.21.21268058 ◽

2021 ◽

Author(s):

Thiago Cerqueira-Silva ◽

Jason R Andrews ◽

Viviane S Boaventura ◽

Otavio T Ranzani ◽

Vinicius de Araujo Oliveira ◽

...

Keyword(s):

Case Control Study ◽

Conditional Logistic Regression ◽

Case Control ◽

Rt Pcr ◽

Symptomatic Infection ◽

Series Completion ◽

Negative Controls ◽

Prior Infection ◽

Control Study ◽

Dose Vaccine

Background. COVID-19 vaccines have proven highly effective among SARS-CoV-2 naive individuals, but their effectiveness in preventing symptomatic infection and severe outcomes among individuals with prior infection is less clear. Methods. Utilizing national COVID-19 notification, hospitalization, and vaccination datasets from Brazil, we performed a case-control study using a test-negative design to assess the effectiveness of four vaccines (CoronaVac, ChAdOx1, Ad26.COV2.S and BNT162b2) among individuals with laboratory-confirmed prior SARS-CoV-2 infection. We matched RT-PCR positive, symptomatic COVID-19 cases with RT-PCR-negative controls presenting with symptomatic illnesses, restricting both groups to tests performed at least 90 days after an initial infection. We used multivariable conditional logistic regression to compare the odds of test positivity, and the odds of hospitalization or death due to COVID-19, according to vaccination status and time since first or second dose of vaccines. Findings. Among individuals with prior SARS-CoV-2 infection, vaccine effectiveness against symptomatic infection ≥ 14 days from vaccine series completion was 39.4% (95% CI 36.1-42.6) for CoronaVac, 56.0% (95% CI 51.4-60.2) for ChAdOx1, 44.0% (95% CI 31.5-54.2) for Ad26.COV2.S, and 64.8% (95% CI 54.9-72.4) for BNT162b2. For the two-dose vaccine series (CoronaVac, ChAdOx1, and BNT162b2), effectiveness against symptomatic infection was significantly greater after the second dose compared with the first dose. Effectiveness against hospitalization or death ≥ 14 days from vaccine series completion was 81.3% (95% CI 75.3-85.8) for CoronaVac, 89.9% (95% CI 83.5-93.8) for ChAdOx1, 57.7% (95% CI -2.6-82.5) for Ad26.COV2.S, and 89.7% (95% CI 54.3-97.7) for BNT162b2.

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EVALUATION OF EFFECTIVENESS OF AROGYA KASHAYAM-20 IN COVID-19 CASES - A RANDOMIZED CONTROLLED STUDY

10.31219/osf.io/au3ct ◽

2021 ◽

Author(s):

Umesh Shukla ◽

Nitin Ujjaliya

Keyword(s):

Controlled Trial ◽

Care Center ◽

Large Population ◽

Intervention Group ◽

Controlled Study ◽

Control Group ◽

Rt Pcr ◽

Randomized Controlled ◽

Group A ◽

Negative Conversion

Introduction: The characteristic clinical features of Covid-19 disease range between asymptomatic to mild-moderate symptoms. Studies suggest that a large population (80%) presents its asymptomatic or milder form. Remaining 20 percent, owing to severity of the diseases, need hospital-based care. Many treatment protocols and strategies have been promoted and recommended by authorities including WHO, but nothing has actually been finalized till date. The present study was planned to evaluate the effectiveness of an Ayurvedic formulation viz. Arogya Kashayam-20 in the hospitalized cases of Covid-19.Aim: To evaluate the effectiveness of Arogya Kashayam-20 in the cases of COVID-19 particularly the negative conversion of RTPCR in 10 days duration.Material and Methods: This was a randomized controlled trial conducted at COVID-19 Care Center, Pt. Khushilal Sharma Government Ayurveda College & Institute, Bhopal, Madhya Pradesh with a sample size of 112 participants, aged between 16 to 60 years of either sex. Participants were divided in two groups viz. group A and B. Both the groups received Hydroxychloroquine (HCQ), vitamin C and Zinc as per the prevailing ICMR guidelines and group 'A' received additionally Arogya Kashayam-20 for 10 days. Outcome measure of the study was to see the negative conversion RT-PCR test after intervention period of 10 days. CTRI Registration: CTRI/2020/06/026221. Results: Among the 60 cases registered in study group (group A), 51 cases (85.00%) were reported with negative RTPCR on 10th day. Out of 52 cases registered in control group (group B); 39 cases (75.00%) were tested negative RTPCR on 10th day. In both the groups all the cases were discharged asymptomatically on 10th day as per the prevailing ICMR guidelines. No ADR/AE observed during the intervention period.Conclusion: The study observes that the add on intervention group has a better outcome in terms of RT-PCR negative reports after 10 days comparing to the control group.

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