scholarly journals Protocol for Safely Collecting Saliva as a Biospecimen During and Post the COVID-19 Pandemic

2021 ◽  
Author(s):  
Yolanda Vasquez-Salgado ◽  
Amanda Thwaits ◽  
Jean Pauline Serrano ◽  
Shu-Sha Angie Guan

Abstract The emergence of salivary bioscience began in the 1980’s, around the same time that researchers discovered we could assess cortisol through the gathering of saliva. In recent decades, the field of salivary bioscience has exponentially grown in scientific interest. This is likely due to the fact that interest in salivary cortisol has risen as well as the emergence of noninvasive procedures to collect other biomarkers of health (e.g., c-reactive protein, alpha amylase, uric acid) through saliva. However, the global health crisis caused by coronavirus disease 2019 (COVID-19) has presented challenges to biomedical researchers. The current manuscript provides detailed guidelines for safely collecting saliva as a biospecimen during and post the era of COVID-19. The protocol has six sections: screenings, package creation and mailing, sample collection demonstration, a contact-free drop-off or pick-up, text message reminders, and storage. Depending on participant screening responses and consistent with quarantine timelines suggested by the Center for Disease Control and Prevention (CDC), the entire protocol can be completed between 4 to 18 days, excluding package creation and mailing. The steps outlined can be accommodated by scientists with developing and mastery level expertise. The protocol can be applied to existing salivary bioscience protocols and maximize safety in the presence of other infectious diseases.

2005 ◽  
Vol 24 (2) ◽  
pp. 85-93
Author(s):  
Svetlana Ignjatovic

Inflammation plays a key role in the pathophysiology of atherosclerotic disease. A number of inflammatory markers that are measurable in blood have been investigated for their ability to predict the risk of future atherosclerotic events. High-sensitivity (hs) measurement of C-reactive protein (CRP) has received a great deal of attention recently for use as an atherosclerotic risk marker. For these reasons, CRP is currently the inflammatory marker of choice. The Centers for Disease Control and Prevention (CCDC) and the American Heart Association (AHA) issued guidelines for the utility of this marker in the primary prevention setting and in patients with stable coronary disease or acute coronary syndromes. The guidelines also included specific recommendations that pertain to the laboratory aspect of CRP and defined cut-points for clinical interpretation; CRP concentrations <1 mg/L are considered low, 1-3 mg/L average, and >3 mg/L high relative risk. A number of preanalytical and analytical factors including specimen type and stability, assay imprecision, commercial availability, and standardization are reviewed here. Better control of preanalytic and analytic sources of variations will undoubtedly lead to improvement in CRP measurements. Further research is required to better define the performance characteristics necessary for assays bearing the designation hsCRP. These characteristics include developing guidelines for total analytical error from a careful review of the intraindividual biological variability of the analyte under conditions that will be encountered in clinical practice, defining allowable random and systematic error limits based on this information, validating these guidelines in the clinical setting, and completing the standardization efforts.


2021 ◽  
Vol 36 ◽  
pp. 123-128
Author(s):  
Induparkavi Murugesan ◽  
Sanjeev B. Rai

Objectives: Serial C-reactive protein (CRP) monitoring helps to rule out and prognosticate sepsis. Small blood volumes in neonates make it difficult for repeated blood draws for serial CRP monitoring. Hence, the need of the hour is a non-invasive method such as CRP estimation in saliva. This study aims to correlate salivary CRP with serum CRP levels and establish the potential clinical utility of salivary CRP in diagnosing neonatal sepsis. Materials and Methods: Twenty-three consecutive neonates diagnosed with clinically suspected sepsis and admitted to the NICU were the study subjects. Demographics such as gestational age and weight at birth, sex and detailed clinical features, and comorbidities were noted. Blood samples for CRP estimation and blood culture were collected as soon as clinical suspicion of sepsis arose. Saliva samples were collected for CRP estimation within 1 h of blood sample collection. The saliva was collected in a 2 mL syringe using low suction. Salivary and serum CRP were estimated by the particle enhanced immunoturbidimetric assay. Results: In our study, the CRP levels in saliva correlated moderately well with CRP levels in serum (Spearman correlation coefficient r = 0.582, P = 0.004). The sensitivity and specificity of salivary CRP to predict a serum level of ≥10 mg/L were observed to be 0.75 and 0.93, respectively. Conclusion: Our study shows the promise of salivary CRP as a potential clinically meaningful biomarker of neonatal sepsis and warrants the need for larger studies to validate the utility of salivary CRP to serially monitor neonatal sepsis.


2018 ◽  
Vol 14 (2) ◽  
pp. 167-173 ◽  
Author(s):  
Lalit Kalra ◽  
Craig J Smith ◽  
John Hodsoll ◽  
Andy Vail ◽  
Saddif Irshad ◽  
...  

Background and aim Pyrexia-dependent clinical algorithms may under or overdiagnose stroke-associated pneumonia. This study investigates whether inclusion of elevated C-reactive protein as a criterion improves diagnosis. Methods The contribution of C-reactive protein  ≥30 mg/l as an additional criterion to a Centers for Disease Control and Prevention-based algorithm incorporating pyrexia with chest signs and leukocytosis and/or chest infiltrates to diagnose stroke-associated pneumonia was assessed in 1088 acute stroke patients from 37 UK stroke units. The sensitivity, specificity, and positive predictive value of different approaches were assessed using adjudicated stroke-associated pneumonia as the reference standard. Results Adding elevated C-reactive protein to all algorithm criteria did not increase diagnostic accuracy compared with the algorithm alone against adjudicated stroke-associated pneumonia (sensitivity 0.74 (95% CI 0.65–0.81) versus 0.72 (95% CI 0.64–0.80), specificity 0.97 (95% CI 0.96–0.98) for both; kappa 0.70 (95% CI 0.63–0.77) for both). In afebrile patients (n = 965), elevated C-reactive protein with chest and laboratory findings had sensitivity of 0.84 (95% CI 0.67–0.93), specificity of 0.99 (95% CI 0.98–1.00), and kappa 0.80 (95% CI 0.70–0.90). The modified algorithm of pyrexia or elevated C-reactive protein and chest signs with infiltrates or leukocytosis had sensitivity of 0.94 (95% CI 0.87–0.97), specificity of 0.96 (95% CI 0.94–0.97), and kappa of 0.88 (95% CI 0.84–0.93) against adjudicated stroke-associated pneumonia. Conclusions An algorithm consisting of pyrexia or C-reactive protein ≥30 mg/l, positive chest signs, leukocytosis, and/or chest infiltrates has high accuracy and can be used to standardize stroke-associated pneumonia diagnosis in clinical or research settings. Trial Registration http://www.isrctn.com/ISRCTN37118456


Author(s):  
Ishan Paranjpe ◽  
Adam J Russak ◽  
Jessica K De Freitas ◽  
Anuradha Lala ◽  
Riccardo Miotto ◽  
...  

ABSTRACTBackgroundThe coronavirus 2019 (Covid-19) pandemic is a global public health crisis, with over 1.6 million cases and 95,000 deaths worldwide. Data are needed regarding the clinical course of hospitalized patients, particularly in the United States.MethodsDemographic, clinical, and outcomes data for patients admitted to five Mount Sinai Health System hospitals with confirmed Covid-19 between February 27 and April 2, 2020 were identified through institutional electronic health records. We conducted a descriptive study of patients who had in-hospital mortality or were discharged alive.ResultsA total of 2,199 patients with Covid-19 were hospitalized during the study period. As of April 2nd, 1,121 (51%) patients remained hospitalized, and 1,078 (49%) completed their hospital course. Of the latter, the overall mortality was 29%, and 36% required intensive care. The median age was 65 years overall and 75 years in those who died. Pre-existing conditions were present in 65% of those who died and 46% of those discharged. In those who died, the admission median lymphocyte percentage was 11.7%, D-dimer was 2.4 ug/ml, C-reactive protein was 162 mg/L, and procalcitonin was 0.44 ng/mL. In those discharged, the admission median lymphocyte percentage was 16.6%, D-dimer was 0.93 ug/ml, C-reactive protein was 79 mg/L, and procalcitonin was 0.09 ng/mL.ConclusionsThis is the largest and most diverse case series of hospitalized patients with Covid-19 in the United States to date. Requirement of intensive care and mortality were high. Patients who died typically had pre-existing conditions and severe perturbations in inflammatory markers.


2003 ◽  
Vol 10 (4) ◽  
pp. 652-657 ◽  
Author(s):  
Najib Aziz ◽  
John L. Fahey ◽  
Roger Detels ◽  
Anthony W. Butch

ABSTRACT C-reactive protein (CRP) is an acute-phase reactant whose levels increase in response to a variety of inflammatory stimuli. Elevated levels in serum are observed after trauma, tissue necrosis, infection, surgery, and myocardial infarction and are associated with an increased risk of cardiovascular disease. CRP levels are also elevated in noninflammatory states, such as obesity, sleep disturbances, depression, chronic fatigue, aging, and physical inactivity. In this study, the performance of a highly sensitive CRP enzyme immunoassay was evaluated, along with common laboratory variables (specimen type, processing time, and storage conditions) that may influence measured blood concentrations of CRP. The measurement range of the assay was from 0.4 to 50 μg/liter. Total imprecision (coefficient of variation) ranged from 8.1 to 11.4%. CRP levels obtained with the enzyme immunoassay were highly correlated with those obtained with an automated immunonephelometric assay. Comparable results were obtained for plasma (heparin and EDTA treated) and serum samples, and levels were unaffected by delays in sample processing and storage temperature. CRP levels were also unaffected by up to seven freeze-thaw cycles. The median CRP concentration in healthy adults was determined to be 0.94 mg/liter, with a 95% working reference interval of 0 to 6.9 mg/liter. In view of these data, we recommend that serial serum or plasma samples for CRP should be stored at 4oC for short periods of time or at −70oC for longer periods and tested within the same run to minimize interassay variability.


2020 ◽  
Author(s):  
Cheng Li ◽  
Cristina Ojeda Thies ◽  
Chi Xu ◽  
Andrej Trampuz

Abstract Background: Because there is no single gold-standard method for the diagnosis of periprosthetic joint infection (PJI), the combination of valuable methods to evaluate infection seems to achieve a better diagnostic result. The objective of the present study was to evaluate the diagnostic value of serum interleukin (IL)-6 and C-reactive protein (CRP) for the diagnosis of PJI.Methods: PubMed, Embase, and the Web of Science databases were searched for articles describing PJI diagnosis using serum IL-6 and CRP published between January 1990 and December 2019.Results: Eight studies were included in the meta-analysis. The pooled sensitivity was 0.79 (95% confidence interval [CI]: 0.73 to 0.83) for the combined method (serum IL-6 and CRP), 0.87 (95% CI: 0.82 to 0.91) for IL-6 and 0.83 (95% CI: 0.78 to 0.87) for CRP . The pooled specificity was 0.92 (95% CI: 0.89 to 0.95) for the combined method, 0.85 (95% CI: 0.81 to 0.88) for IL-6, and 0.83 (95% CI: 0.79 to 0.87) for CRP. The combined method had the highest value for the area under the curve (0.9688), followed by IL-6 (0.9259) and CRP (0.9139). Subgroup analyses showed that restricting antibiotic treatment before sample collection may improve specificity.Conclusion: The combination of serum IL-6 and CRP was a reliable tool for the diagnosis of PJI, and it had a better diagnostic accuracy than testing with a single marker, especially when samples were collected without antibiotic therapy. Additional research is needed.


2021 ◽  
Vol 8 (3) ◽  
pp. 407
Author(s):  
Dhiraj Chandra Biswas ◽  
Moshiur Rahman ◽  
Farzana Sharmin ◽  
Ismat Jahan ◽  
Ananya Roy ◽  
...  

Background: Obesity is an exaggeration of normal adiposity. Central obesity in children has increased than general adiposity now a days, which is not routinely measured in clinical practice. Adipose tissue contributes to the secretion of a number of inflammatory cytokines which stimulate the production of high-sensitive C-reactive protein (hs–CRP) by the liver. The study was done to see the association of hs-CRP level with central obesity in Bangladeshi children.Methods: A total of 110 obese children aged between 10 to 18 years with BMI≥95th centile and age and sex matched 55 non-obese children with BMI≥5th to <85th centile according to centers for disease control and prevention (CDC) growth chart were selected. A structured questionnaire was prepared taking into account demographic and clinical parameters. The hs-CRP were estimated in study subjects and then correlated to central obesity by waist height ratio (WHtR).Results: The prevalence central obesity was 45.5% by WHtR and raised hs-CRP levels was 46.4% in obese children. About 62% of obese children had central obesity who had raised hs-CRP level ≥2 mg/l (high risk), which showed significant positive correlation with WHtR and was significantly raised in obese children.Conclusions: A high proportion of central obesity was observed in obese children who had raised hs-CRP level, suggesting that it might be useful to assess future metabolic and cardiovascular complication.


BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e040736 ◽  
Author(s):  
Ishan Paranjpe ◽  
Adam J Russak ◽  
Jessica K De Freitas ◽  
Anuradha Lala ◽  
Riccardo Miotto ◽  
...  

ObjectiveThe COVID-19 pandemic is a global public health crisis, with over 33 million cases and 999 000 deaths worldwide. Data are needed regarding the clinical course of hospitalised patients, particularly in the USA. We aimed to compare clinical characteristic of patients with COVID-19 who had in-hospital mortality with those who were discharged alive.DesignDemographic, clinical and outcomes data for patients admitted to five Mount Sinai Health System hospitals with confirmed COVID-19 between 27 February and 2 April 2020 were identified through institutional electronic health records. We performed a retrospective comparative analysis of patients who had in-hospital mortality or were discharged alive.SettingAll patients were admitted to the Mount Sinai Health System, a large quaternary care urban hospital system.ParticipantsParticipants over the age of 18 years were included.Primary outcomesWe investigated in-hospital mortality during the study period.ResultsA total of 2199 patients with COVID-19 were hospitalised during the study period. As of 2 April, 1121 (51%) patients remained hospitalised, and 1078 (49%) completed their hospital course. Of the latter, the overall mortality was 29%, and 36% required intensive care. The median age was 65 years overall and 75 years in those who died. Pre-existing conditions were present in 65% of those who died and 46% of those discharged. In those who died, the admission median lymphocyte percentage was 11.7%, D-dimer was 2.4 μg/mL, C reactive protein was 162 mg/L and procalcitonin was 0.44 ng/mL. In those discharged, the admission median lymphocyte percentage was 16.6%, D-dimer was 0.93 μg/mL, C reactive protein was 79 mg/L and procalcitonin was 0.09 ng/mL.ConclusionsIn our cohort of hospitalised patients, requirement of intensive care and mortality were high. Patients who died typically had more pre-existing conditions and greater perturbations in inflammatory markers as compared with those who were discharged.


Author(s):  
Nikolas I Wada ◽  
Elizabeth C Breen ◽  
Wendy S Post ◽  
Valentina Stosor ◽  
Bernard J Macatangay ◽  
...  

Abstract Background C-reactive protein (CRP) is an inflammatory biomarker associated with all-cause mortality and morbidities such as cardiovascular disease. CRP is increased with HIV infection and thought to increase with age, though trajectories of CRP with aging have not been well characterized. We investigated trajectories of CRP in men from the Multicenter AIDS Cohort Study, according to HIV infection and HIV viral load status. Methods CRP measurements from 12,250 serum samples, provided by 2,132 men over a span of 30 years, were categorized by HIV status at sample collection: HIV-uninfected (HIV-, n=1,717), HIV-infected, HIV+, undetectable RNA (HIV+ suppressed, n=4,075), and detectable HIV RNA (HIV+ detectable, n=6,458). Age-related trajectories of CRP were fit to multivariable linear mixed models; we tested for differences in trajectories by HIV status. Results CRP increased with age in all sample groups. HIV+ detectable and HIV+ suppressed samples had higher CRP than HIV- samples throughout the observed age range of 20-70 years (p&lt;0.05). CRP concentrations at age 45 years were 38% (95% CI: 26%-50%) and 26% (15%-38%) higher in HIV+ detectable and HIV+ suppressed samples, respectively, relative to HIV- samples. HIV+ detectable samples showed more rapid linear increases with age (8% higher/decade, 0.3%-16%) than HIV- samples. Conclusions We observed higher concentrations of CRP across five decades of age in men living with HIV, and steeper increases with age in men with detectable HIV RNA, relative to HIV- men. These results are consistent with a contribution of inflammation to the higher risk of age-related comorbidities with HIV infection.


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