New COVID-19 saliva-based test: How good is it compared with the current nasopharyngeal or throat swab test?

Hung, Kai Feng; Sun, Yi; Chen, Binghong; Lo, Jeng‐Fan; Cheng, Chao; Chen, Cho-Yi; Wu, Cheng Hsien; Kao, Shou Yen

doi:10.1097/jcma.0000000000000396

Cited by 58 publications

(61 citation statements)

References 26 publications

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“…The FDA has moved rapidly to authorize hundreds of molecular tests for Emergency Use during the COVID-19 pandemic and has dramatically expanded access to testing (32). However, the number of tests authorized for alternative specimen types such as oral fluid or saliva which can provide easy, high-throughput access to regular testing, has remained small (33), despite these specimen types being shown to be highly effective (15, 34, 35, 36, 37). And in fact there still remains no test authorized for use in asymptomatic screening using saliva or oral fluid.…”

Section: Discussionmentioning

confidence: 99%

Post-Disease Divergence in SARS-CoV-2 RNA Detection between Nasopharyngeal, Anterior Nares and Saliva/Oral Fluid Specimens - Significant Implications for Policy & Public Health

Turner¹,

Vandenberg²,

Vi³

et al. 2021

Preprint

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BackgroundPatients have been shown to shed SARS-CoV-2 viral RNA in nasopharyngeal (NP) specimens for over 100 days after resolution of clinical disease (1, 2). How this relates to anterior nares and oral fluid specimens has not previously been investigated.MethodsWe prospectively collected oral fluid, anterior nares, NP swab and serum specimens from 1,326 individuals at 2 “drive-through” testing locations. The Curative SARS-CoV-2 Assay (Curative Assay)(3) on oral fluid and anterior nares specimens was compared to the EURORealTime SARS-CoV-2 Assay (EuroRT Assay)(4) on anterior nares and NP specimens. Viral culture and IgG serology were used to assess infectious potential and stage of disease.Additionally we investigated differences in viral RNA detection between specimen types, both early (< 21 days) and late (> 21 days) in SARS-CoV-2 infection, by using an employee surveillance program with daily SARS-CoV-2 testing to precisely determine infection date, even without symptoms. We prospectively collected oral fluid, anterior nares and NP swab specimens from 165 subjects with early infections and 22 subjects with late infections. Specimens were tested using the Curative Assay with the “high-sensitivity” Hologic Aptima SARS-CoV-2 Assay (Hologic Assay)(5) on an NP swab used as the comparator. Late infection specimens were also tested with EuroRT and Zymo Quick SARS-CoV-2 rRT-PCR Kit (Zymo) (6) Assays.ResultsThe “drive-through” study showed similar sensitivities of oral fluid and anterior nares specimens on the Curative Assay to anterior nares specimens tested with the EuroRT Assay. However NP specimens tested with the same EuroRT assay produced 20-30% more positives. Incorporating viral culture and serology data to exclude NP RT-PCR positives that are not infectious or late in the course of disease showed a Positive Percent Agreement (PPA) for of 98.2% and 96.2% and Negative Percent Agreement (NPA) of 97.6% and 98.1% for anterior nares and oral fluid specimens, respectively.Within 21 days of infection, the Curative Assay showed a PPA and NPA of 100% and 100%, respectively for oral fluid; of 100% and 99% respectively for anterior nares; and of 98.2% and 99.0%, respectively in nasopharyngeal specimens compared to an NP specimen on the Hologic Assay. 29 positives were asymptomatic and showed 100% PPA and 100% NPA for all specimen types. After 21 days from infection onset, significant divergence between NP and other specimen types occurred on all 4 assays. Out of 22 paired sample sets, 18, 13, 8 and 4 NP specimens were positive on the Curative, Zymo, Hologic and EuroRT assays, respectively, compared to only 3, 2, 0 and 1 positive anterior nares specimens. Only one oral fluid sample was positive in both the Curative and Zymo assays.ConclusionsWe used a unique population to show significant divergence between NP specimens and anterior nares or oral fluid specimens >21 days from SARS-CoV-2 infection, which appears to be biological variation and is independent of assay used. This has significant public health implications for the use of NP specimens in community testing programs and policy implications for evaluation of novel specimen types and tests where the use of NP swabs as a comparator may say more about the study population than the assay or specimen type to be evaluated and may unnecessarily limit access to testing.

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Section: Discussionmentioning

confidence: 99%

Post-Disease Divergence in SARS-CoV-2 RNA Detection between Nasopharyngeal, Anterior Nares and Saliva/Oral Fluid Specimens - Significant Implications for Policy & Public Health

Turner¹,

Vandenberg²,

Vi³

et al. 2021

Preprint

View full text Add to dashboard Cite

show abstract

“…( 4 ) Unfortunately, they noted that “many patients did not undergo sputum bacteriologic or fungal assessment on admission because, in some hospitals, medical resources were overwhelmed.” There may also be difficulty in collecting sputum samples from COVID-19 patients as they are not always attainable from patients who do not have a productive cough and furthermore, induction of cough may promote viral spread. ( 5 ) Zhou et al , in an analysis of 191 hospitalised adult COVID-19 patients in Wuhan, found that sepsis was the most frequently-observed complication in both non-survivors and survivors of the disease. ( 6 ) The authors noted that sepsis could have resulted from viral infection in these patients and hence, specific data confirming bacterial involvement in COVID-19 were still needed.…”

Section: Emergence Of Reports Of Bacterial Infections Related To Covid-19mentioning

confidence: 99%

The interface between COVID-19 and bacterial healthcare-associated infections

O'Toole

2021

Clinical Microbiology and Infection

129

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Background A wide range of bacterial infections occur in COVID-19 patients, particularly, in those with severe coronaviral disease. Some of these are community acquired co-infections. Objective To review recent data which indicate the occurrence of hospital-onset bacterial infections, including with antibiotic-resistant isolates, in COVID-19 patients. Sources Using PubMed, the literature was searched using terms including: “COVID-19”; “SARS-CoV-2”; “bacterial infection”; “healthcare-associated infection”; “antibiotic resistance”; “antimicrobial resistance”; “multi-drug resistance”; “ Streptococcus ”; “ Staphylococcus ”; “ Pseudomonas ”; “ Escherichia ”; “ Klebsiella ”; “ Enterococcus ”; “ Acinetobacter ”; “ Haemophilus ”; “MRSA”; “VRE”; “ESBL”; “NDM-CRE”; “CR-Ab”; “VRSA”; “MDR”. Content There is a growing number of reports of bacterial infections acquired by patients with severe COVID-19 after hospital admission. Antibiotic-resistant pathogens found to cause healthcare-associated infections (HAIs) in COVID-19 patients include Methicillin-Resistant Staphylococcus aureus (MRSA), New Delhi Metallo-β-lactamase-producing Carbapenem-Resistant Enterobacterales (NDM-CRE), Carbapenem-Resistant Acinetobacter baumannii (CR-Ab), Extended-Spectrum β-Lactamase (ESBL) Klebsiella pneumoniae , and Vancomycin-Resistant Enterococci (VRE). COVID-19 has impacted bacterial HAIs in a number of ways with an increase in the incidence of NDM-CRE and CR-Ab reported at some hospital sites compared to before the pandemic. Recommended guidelines for antimicrobial stewardship in COVID-19 patient treatment are discussed regarding minimisation of empiric broad-spectrum antibiotic use. Other studies have reported a decrease in MRSA and VRE cases that has been attributed to enhanced infection prevention and control (IPC) practices introduced to minimise intra-hospital spread of COVID-19. Implications Poorer outcomes have been observed in hospitalised COVID-19 patients with an antibiotic-resistant infection. While heightened IPC measures have been accompanied by a reduction in some HAIs at specific sites, in other situations, COVID-19 has been associated with an increase in bacterial HAI incidence. Further research is needed to define the cost-benefit relationship of maintaining COVID-19-related IPC protocols beyond the pandemic to reduce the burden of HAIs. In addition, the longer-term impact of high usage of certain broad-spectrum antibiotics during the COVID-19 pandemic requires evaluation.

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“…Suggested solution ratios Suggested volume of the solution American Dental Association [35] Hydrogen Peroxide 1.5% 15 ml American Dental Association [35] Povidone-iodine 0.2% 9 ml Mady et al [36] 0.4% Challacombe et al [37] 0.5% Yoon et al [39] Chlorhexidine 0.12% from the oral cavity, thus aerosol is not mixed with the saliva of the patient. Which has a high viral load as mentioned before in this review.…”

Section: Active Agentmentioning

confidence: 99%

“…The RT-PCR can be performed using Applied Biosystems TaqPath Combo Kit on the ThermoFisher Applied Biosystems QuantStudio 5 Real-Time PCR System or the Applied Biosystems ViiA7 Real-Time PCR System. 39 How should we perform the saliva testing? : The saliva collection method and types of collection devices are critical issues in this detection technique.…”

Section: Covid-19 Detection With Salivamentioning

confidence: 99%

Saliva: Both a Threat and an Opportunity in Covid-19 Pandemic

Sadıkoğlu

Caymaz

2021

Pak J Med Sci

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Covid-19 pandemic, continues all over the world with the increasing number of confirmed cases and performed tests day by day. It has been shown that collecting nasopharyngeal samples, as the most commonly prefered method to perform RT-PCR, has disadvantages like causing discomfort and bleeding in patients. Sample collecting procedure also renders healthcare professionals by exposing them to the risk of transmission of the virus related to the direct contact with patients. These disadvantages make this procedure undesirable for the researchers and forces them to search for an alternative technique. At this point, saliva appears as an opportunity, regarding its high viral load. On the other hand, this high viral load poses a threat, especially for professions such as dental practitioners, with too much aerosol exposure. Since dentistry is a branch of health that constantly needs direct operations, it is necessary to be protected from the virus as much as possible while caring for the patient. A literature review was done using electronic databases “PubMed,” “Google Scholar,” and “Cochrane Database,” on January 2021. Studies have proposed many different preventive measures in this regard. Therefore, the purpose of this review is to draw attention to the saliva by bringing together the recent research and also to provide information and a perspective to dental clinicians about both prevention and a potential diagnostic technique. doi: https://doi.org/10.12669/pjms.37.4.4263 How to cite this:Sadikoglu IS, Caymaz MG. Saliva: Both a Threat and an Opportunity in Covid-19 Pandemic. Pak J Med Sci. 2021;37(4):---------. doi: https://doi.org/10.12669/pjms.37.4.4263 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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New COVID-19 saliva-based test: How good is it compared with the current nasopharyngeal or throat swab test?

Cited by 58 publications

References 26 publications

Post-Disease Divergence in SARS-CoV-2 RNA Detection between Nasopharyngeal, Anterior Nares and Saliva/Oral Fluid Specimens - Significant Implications for Policy & Public Health

Post-Disease Divergence in SARS-CoV-2 RNA Detection between Nasopharyngeal, Anterior Nares and Saliva/Oral Fluid Specimens - Significant Implications for Policy & Public Health

The interface between COVID-19 and bacterial healthcare-associated infections

Saliva: Both a Threat and an Opportunity in Covid-19 Pandemic

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