scholarly journals Suitability and Sufficiency of Telehealth Clinician-Observed, Participant-Collected Samples for SARS-CoV-2 Testing: The iCollect Cohort Pilot Study (Preprint)

2020 ◽  
Author(s):  
Jodie L Guest ◽  
Patrick S Sullivan ◽  
Mariah Valentine-Graves ◽  
Rachel Valencia ◽  
Elizabeth Adam ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Rnase P ◽  
Ribonuclease P ◽  
Laboratory Assessment ◽  
Testing Strategies ◽  
Specimen Collection ◽  
Oropharyngeal Swab ◽  
Polymerase Chain ◽  
Respiratory Coronavirus ◽  
Serology Testing

BACKGROUND The severe acute respiratory coronavirus 2 (SARS-CoV-2) pandemic calls for expanded opportunities for testing, including novel testing strategies such as home-collected specimens. OBJECTIVE We aimed to understand whether oropharyngeal swab (OPS), saliva, and dried blood spot (DBS) specimens collected by participants at home and mailed to a laboratory were sufficient for use in diagnostic and serology tests of SARS-CoV-2. METHODS Eligible participants consented online and were mailed a participant-collection kit to support collection of three specimens for SARS-CoV-2 testing: saliva, OPS, and DBS. Participants performed the specimen collection procedures during a telehealth video appointment while clinical observers watched and documented the suitability of the collection. The biological sufficiency of the specimens for detection of SARS-CoV-2 by reverse transcriptase–polymerase chain reaction and serology testing was assessed by laboratorians using visual inspection and quantification of the nucleic acid contents of the samples by ribonuclease P (RNase P) measurements. RESULTS Of the enrolled participants,153/159 (96.2%) returned their kits, which were included in this analysis. All these participants attended their video appointments. Clinical observers assessed that of the samples collected, 147/153 (96.1%) of the saliva samples, 146/151 (96.7%) of the oropharyngeal samples, and 135/145 (93.1%) of the DBS samples were of sufficient quality for submission for laboratory testing; 100% of the OPS samples and 98% of the saliva samples had cycle threshold values for RNase P <30, indicating that the samples contained sufficient nucleic acid for RNA-PCR testing for SARS-CoV-2. CONCLUSIONS These pilot data indicate that most participant-collected OPS, saliva, and DBS specimens are suitable and sufficient for testing for SARS-CoV-2 RNA and serology. Clinical observers rated the collection of specimens as suitable for testing, and visual and quantitative laboratory assessment indicated that the specimens were biologically sufficient. These data support the utility of participant-collected and mailed-in specimens for SARS-CoV-2 testing. INTERNATIONAL REGISTERED REPORT RR2-10.2196/19054

scholarly journals Suitability and Sufficiency of Telehealth Clinician-Observed, Participant-Collected Samples for SARS-CoV-2 Testing: The iCollect Cohort Pilot Study

10.2196/19731 ◽  
2020 ◽  
Vol 6 (2) ◽  
pp. e19731 ◽  
Author(s):  
Jodie L Guest ◽  
Patrick S Sullivan ◽  
Mariah Valentine-Graves ◽  
Rachel Valencia ◽  
Elizabeth Adam ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Rnase P ◽  
Ribonuclease P ◽  
Laboratory Assessment ◽  
Testing Strategies ◽  
Specimen Collection ◽  
Oropharyngeal Swab ◽  
Polymerase Chain ◽  
Respiratory Coronavirus ◽  
Serology Testing

Background The severe acute respiratory coronavirus 2 (SARS-CoV-2) pandemic calls for expanded opportunities for testing, including novel testing strategies such as home-collected specimens. Objective We aimed to understand whether oropharyngeal swab (OPS), saliva, and dried blood spot (DBS) specimens collected by participants at home and mailed to a laboratory were sufficient for use in diagnostic and serology tests of SARS-CoV-2. Methods Eligible participants consented online and were mailed a participant-collection kit to support collection of three specimens for SARS-CoV-2 testing: saliva, OPS, and DBS. Participants performed the specimen collection procedures during a telehealth video appointment while clinical observers watched and documented the suitability of the collection. The biological sufficiency of the specimens for detection of SARS-CoV-2 by reverse transcriptase–polymerase chain reaction and serology testing was assessed by laboratorians using visual inspection and quantification of the nucleic acid contents of the samples by ribonuclease P (RNase P) measurements. Results Of the enrolled participants,153/159 (96.2%) returned their kits, which were included in this analysis. All these participants attended their video appointments. Clinical observers assessed that of the samples collected, 147/153 (96.1%) of the saliva samples, 146/151 (96.7%) of the oropharyngeal samples, and 135/145 (93.1%) of the DBS samples were of sufficient quality for submission for laboratory testing; 100% of the OPS samples and 98% of the saliva samples had cycle threshold values for RNase P <30, indicating that the samples contained sufficient nucleic acid for RNA-PCR testing for SARS-CoV-2. Conclusions These pilot data indicate that most participant-collected OPS, saliva, and DBS specimens are suitable and sufficient for testing for SARS-CoV-2 RNA and serology. Clinical observers rated the collection of specimens as suitable for testing, and visual and quantitative laboratory assessment indicated that the specimens were biologically sufficient. These data support the utility of participant-collected and mailed-in specimens for SARS-CoV-2 testing. International Registered Report Identifier (IRRID) RR2-10.2196/19054

scholarly journals Nasopharyngeal versus nasal swabs for detection of SARS-CoV-2: a systematic review

2021 ◽  
Vol 0 (0) ◽  
pp. 0-0
Author(s):  
A.J. Gadenstaetter ◽  
C.D. Mayer ◽  
L.D. Landegger
Keyword(s):  
Systematic Review ◽  
Sensitivity And Specificity ◽  
Gold Standard ◽  
Medical Staff ◽  
Rt Pcr ◽  
Testing Strategies ◽  
Specimen Collection ◽  
Nasal Swabs ◽  
Oropharyngeal Swab ◽  
Collection Methods

Nasopharyngeal swabbing (NPS) coupled with RT-PCR is the current gold standard for detecting SARS-CoV-2 infections. However, numerous studies have recently demonstrated the advantages of alternative nasal specimen collection approaches over NPS specifically for COVID-19 diagnosis. The present review was conducted according to PRISMA guidelines and summarises the current literature to give a clear overview of nasal specimen collection methods for SARS-CoV-2 detection. Publications investigating NPS and at least one other form of nasal specimen collection in combination with RT-PCR for viral detection in the context of COVID-19 were assessed. We identified 425 articles and ultimately included 18 studies in this systematic review. The suitable publications evaluated different forms of nasal specimen collection, with anterior nasal swabbing (ANS) and midturbinate swabbing (MTS) being the most frequently examined techniques. The analysed studies report sensitivity and specificity results (74.59-96.2% and 97.9-100.0%, respectively) similar to those achieved via NPS, especially in the early stages of disease or when paired with an oropharyngeal swab. Results from these studies suggest that ANS and MTS are suitable alternatives to NPS for COVID-19 testing. Due to their ease of collection, ANS and MTS collection techniques may facilitate broader testing strategies and allow for economization of medical staff.

scholarly journals Comparison of four commercial, automated antigen tests to detect SARS-CoV-2 variants of concern

2021 ◽  
Author(s):  
Andreas Osterman ◽  
Maximilian Iglhaut ◽  
Andreas Lehner ◽  
Patricia Späth ◽  
Marcel Stern ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Point Of Care ◽  
Study Cohort ◽  
Operating Characteristics ◽  
Testing Strategies ◽  
Level 3 ◽  
Amino Acid Mutations ◽  
Antigen Tests ◽  
Roche Diagnostics ◽  
Analytical Sensitivities

AbstractA versatile portfolio of diagnostic tests is essential for the containment of the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) pandemic. Besides nucleic acid-based test systems and point-of-care (POCT) antigen (Ag) tests, quantitative, laboratory-based nucleocapsid Ag tests for SARS-CoV-2 have recently been launched. Here, we evaluated four commercial Ag tests on automated platforms and one POCT to detect SARS-CoV-2. We evaluated PCR-positive (n = 107) and PCR-negative (n = 303) respiratory swabs from asymptomatic and symptomatic patients at the end of the second pandemic wave in Germany (February–March 2021) as well as clinical isolates EU1 (B.1.117), variant of concern (VOC) Alpha (B.1.1.7) or Beta (B.1.351), which had been expanded in a biosafety level 3 laboratory. The specificities of automated SARS-CoV-2 Ag tests ranged between 97.0 and 99.7% (Lumipulse G SARS-CoV-2 Ag (Fujirebio): 97.03%, Elecsys SARS-CoV-2 Ag (Roche Diagnostics): 97.69%; LIAISON® SARS-CoV-2 Ag (Diasorin) and SARS-CoV-2 Ag ELISA (Euroimmun): 99.67%). In this study cohort of hospitalized patients, the clinical sensitivities of tests were low, ranging from 17.76 to 52.34%, and analytical sensitivities ranged from 420,000 to 25,000,000 Geq/ml. In comparison, the detection limit of the Roche Rapid Ag Test (RAT) was 9,300,000 Geq/ml, detecting 23.58% of respiratory samples. Receiver-operating-characteristics (ROCs) and Youden’s index analyses were performed to further characterize the assays’ overall performance and determine optimal assay cutoffs for sensitivity and specificity. VOCs carrying up to four amino acid mutations in nucleocapsid were detected by all five assays with characteristics comparable to non-VOCs. In summary, automated, quantitative SARS-CoV-2 Ag tests show variable performance and are not necessarily superior to a standard POCT. The efficacy of any alternative testing strategies to complement nucleic acid-based assays must be carefully evaluated by independent laboratories prior to widespread implementation.

scholarly journals Comprehensive large-scale nucleic acid–testing strategies support China’s sustained containment of COVID-19

2021 ◽  
Author(s):  
Zhongjie Li ◽  
Fengfeng Liu ◽  
Jinzhao Cui ◽  
Zhibin Peng ◽  
Zhaorui Chang ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Large Scale ◽  
Nucleic Acid Testing ◽  
Testing Strategies

scholarly journals At-home self-collection of saliva, oropharyngeal swabs and dried blood spots for SARS-CoV-2 diagnosis and serology: post-collection acceptability of specimen collection process and patient confidence in specimens

2020 ◽  
Author(s):  
Mariah Valentine-Graves ◽  
Eric Hall ◽  
Jodie Guest ◽  
Elizabeth Adam ◽  
Rachel Valencia ◽  
...  
Keyword(s):  
Immune Response ◽  
Educational Level ◽  
Laboratory Testing ◽  
Dried Blood Spots ◽  
Specimen Collection ◽  
Oropharyngeal Swab ◽  
Race Ethnicity ◽  
Patient Confidence ◽  
Blood Spot ◽  
At Home

AbstractBackgroundOptions to increase the ease of testing for SARS-CoV-2 infection and immune response are needed. Self-collection of diagnostic specimens at home offers an avenue to allow people to test for SARS-CoV-2 infection or immune response without traveling to a clinic or laboratory. Before this study, survey respondents indicated willingness to self-collect specimens for COVID-related tests, but hypothetical willingness can differ from post-collection acceptability after participants collect specimens.Methods153 US adults were enrolled in a study of the willingness and feasibility of patients to self-collect three diagnostic specimens (saliva, oropharyngeal swab (OPS) and dried blood spot (DBS) card) while observed by a clinician through a telehealth session. After the specimens were collected, 148 participants participated in a survey about the acceptability of the collection, packing and shipping process, and their confidence in the samples collected for COVID-related laboratory testing.ResultsA large majority of participants (>84%) reported that collecting, packing and shipping of saliva, OPS, and DBS specimens were acceptable. Nearly nine in 10 (87%) reported being confident or very confident that the specimens they collected were sufficient for laboratory analysis. There were no differences in acceptability for any specimen type, packing and shipping, or confidence in samples by gender, age, race/ethnicity, or educational level.ConclusionsSelf-collection of specimens for SARS-CoV-2 testing and preparing and shipping specimens for analysis were acceptable in a diverse group of US adults. Further refinement of materials and instructions to support self-collection of saliva, OPS and DBS specimens for COVID-related testing is needed.Trial registrationNo intervention was tested in this study

scholarly journals Interplay between substrate recognition, 5’ end tRNA processing and methylation activity of human mitochondrial RNase P

2018 ◽  
Author(s):  
Agnes Karasik ◽  
Carol A. Fierke ◽  
Markos Koutmos
Keyword(s):  
Mitochondrial Diseases ◽  
Protein S ◽  
Rnase P ◽  
Ribonuclease P ◽  
Mitochondrial Rna ◽  
P Protein ◽  
Adenosyl Methionine ◽  
Methylation Activity

ABSTRACTHuman mitochondrial ribonuclease P (mtRNase P) is an essential three protein complex that catalyzes the 5’ end maturation of mitochondrial precursor tRNAs (pre-tRNAs). MRPP3 (Mitochondrial RNase P Protein 3), a protein-only RNase P (PRORP), is the nuclease component of the mtRNase P complex and requires a two-protein S-adenosyl methionine (SAM)-dependent methyltransferase MRPP1/2 sub-complex to function. Dysfunction of mtRNase P is linked to several human mitochondrial diseases, such as mitochondrial myopathies. Despite its central role in mitochondrial RNA processing, little is known about how the protein subunits of mtRNase P function synergistically. Here we use purified mtRNase P to demonstrate that mtRNase P recognizes, cleaves, and methylates some, but not all, mitochondrial pre-tRNAs in vitro. Additionally, mtRNase P does not process all mitochondrial pre-tRNAs uniformly, suggesting the possibility that some pre-tRNAs require additional factors to be cleaved in vivo. Consistent with this, we found that addition of the MRPP1 co-factor SAM enhances the ability of mtRNase P to bind and cleave some mitochondrial pre-tRNAs. Furthermore, the presence of MRPP3 can enhance the methylation activity of MRPP1/2. Taken together, our data demonstrate that the subunits of mtRNase P work together to efficiently recognize, process and methylate human mitochondrial pre-tRNAs.

Defining a Strategy for Laboratory Evaluation with Expectant Management of Preeclampsia

2021 ◽  
Author(s):  
Gabriella D. Cozzi ◽  
Christina T. Blanchard ◽  
Aalok R. Sanjanwala ◽  
Margaret R. Page ◽  
Dhong-Jin Kim ◽  
...  
Keyword(s):  
Expectant Management ◽  
Laboratory Evaluation ◽  
Testing Time ◽  
Laboratory Assessment ◽  
Laboratory Abnormality ◽  
Receiver Operating Characteristic Curves ◽  
Testing Strategies ◽  
Kaplan Meier ◽  
Key Points ◽  
Tertiary Center

Objective The objective of this study was to compare the frequency and timing of laboratory abnormalities and evaluate optimal laboratory testing strategies in women with preeclampsia (PE) undergoing expectant management. Study Design Retrospective cohort study of women with inpatient expectant management of PE at ≥23 weeks at a tertiary center from 2015 to 2018 was conducted. Women ineligible for expectant management or with less than two laboratory sets (platelets, aspartate aminotransferase, and serum creatinine) before the decision to deliver were excluded. Women were categorized as per the American College of Obstetricians and Gynecologists' definitions by initial diagnosis: PE without severe features, superimposed preeclampsia (SiPE) without severe features, and their forms with severe features. The frequency and timing of laboratory abnormalities were compared across the four PE categories. Kaplan–Meier curves modeled time to a laboratory abnormality (event) with censoring for delivery and were compared using log-rank tests. Logistic regression analysis modeled the development of a laboratory abnormality as a function of testing time intervals (days) for each PE type. Receiver operating characteristic curves and areas under the curve (AUC) were calculated; optimal cut points were determined using the Liu method. Results Among 636 women who met inclusion criteria, laboratory abnormalities were uncommon (6.3%). The median time to a laboratory abnormality among all women was ≤10 days, time being shortest in women with PE with severe features. Time to laboratory abnormality development did not differ significantly between the four PE groups (p = 0.36). Laboratory assessment intervals were most predictive for PE and SiPE with severe features (AUC = 0.87, AUC = 0.72). Optimal cutoffs were every 4 days for PE without severe features, 2 days for PE with severe features, 8 days for SiPE without severe features, and 3 days for SiPE with severe features. Conclusion Most laboratory abnormalities in PE occur earlier and more frequently in those with severe features. Individual phenotypes should undergo serial evaluation based on this risk stratification. Key Points

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