scholarly journals Assessment of the analytical sensitivity of ten lateral flow devices against the SARS-CoV-2 omicron variant

2021 ◽  
Author(s):  
Joshua Deerain ◽  
Julian Druce ◽  
Thomas Tran ◽  
Mitchell Batty ◽  
Yano Yoga ◽  
...  
Keyword(s):  
Public Health ◽  
Point Of Care ◽  
Diagnostic Testing ◽  
Rapid Assessment ◽  
Protein A ◽  
Analytical Sensitivity ◽  
Structural Protein ◽  
Public Health Response ◽  
Recent Emergence ◽  
Antigen Tests

Timely and accurate diagnostic testing is a critical component of the public health response to COVID-19. Antigen tests are used widely in many countries to provide rapid, economical and accessible point-of-care testing (1). The vast majority of antigen tests detect nucleocapsid (N) protein, a structural protein that displays less variation than the spike (S) protein across different SARS-CoV-2 lineages. Although antigen tests are less sensitive than RT-PCR tests, their ability to quickly detect individuals with high viral loads provides clinical and public health utility in many countries, including Australia, where antigen tests have recently been approved for self-testing (2). As new variants arise, including the recent emergence of the SARS-CoV-2 omicron variant, it is essential to rapidly assess the performance of diagnostic assays. Here, in order to assess and compare the ability of antigen tests to detect delta and omicron variants, we performed a rapid assessment of ten commercially available antigen tests.

Cross-contamination in molecular laboratories: A challenge to COVID-19 testing in Bangladesh

2021 ◽  
Vol 2 (5) ◽  
Author(s):  
Mohammad Jahidur Rahman Khan ◽  
◽  
Selim Reza ◽  
Farzana Mim ◽  
Md Abdullah Rumman ◽  
...  
Keyword(s):  
Public Health ◽  
Large Scale ◽  
Diagnostic Testing ◽  
Diagnostic Errors ◽  
Laboratory Diagnosis ◽  
Cross Contamination ◽  
Rt Pcr ◽  
Public Health Response ◽  
Surveillance Programs ◽  
The Government

Rapid and accurate laboratory diagnosis of SARS-CoV-2 infection is crucial for the management of COVID-19 patients and control of the spread of the virus. At the start of the COVID-19 pandemic, Bangladesh had only one government molecular laboratory where real-time RT-PCR will be performed to diagnose SARS-CoV-2 infection. With the increasing number of suspected cases requiring confirmation diagnostic testing, there was a requirement to quickly expand capacity for large-scale testing. The government of Bangladesh established over 100 molecular laboratories within one year to test COVID-19. To fulfil the requirement for expanded testing, the government was compelled to recruit laboratory employees with inadequate experience, technical knowledge, and skills in molecular assays, particularly in processing specimens, interpreting results, recognizing errors, and troubleshooting. As a result, the risk of diagnostic errors, such as cross-contamination, is increased, as is that the risk of false-positive results, which might risk the patient’s health and undermine the efficacy of public health policies, public health response, surveillance programs, and restrictive measures aimed toward containing the outbreak. This review article aims to explain different sources of crosscontamination in the COVID-19 RT-PCR laboratories and the way to forestall them in efficient and practical ways.

scholarly journals Early introductions and community transmission of SARS-CoV-2 variant B.1.1.7 in the United States

2021 ◽  
Author(s):  
Tara Alpert ◽  
Erica Lasek-Nesselquist ◽  
Anderson F. Brito ◽  
Andrew L. Valesano ◽  
Jessica Rothman ◽  
...  
Keyword(s):  
Public Health ◽  
United States ◽  
New York ◽  
Diagnostic Testing ◽  
The United States ◽  
International Travel ◽  
Health Concern ◽  
Public Health Response ◽  
Community Transmission ◽  
The Uk

SummaryThe emergence and spread of SARS-CoV-2 lineage B.1.1.7, first detected in the United Kingdom, has become a national public health concern in the United States because of its increased transmissibility. Over 500 COVID-19 cases associated with this variant have been detected since December 2020, but its local establishment and pathways of spread are relatively unknown. Using travel, genomic, and diagnostic testing data, we highlight the primary ports of entry for B.1.1.7 in the US and locations of possible underreporting of B.1.1.7 cases. New York, which receives the most international travel from the UK, is likely one of the key hubs for introductions and domestic spread. Finally, we provide evidence for increased community transmission in several states. Thus, genomic surveillance for B.1.1.7 and other variants urgently needs to be enhanced to better inform the public health response.

scholarly journals Performance evaluation of the point-of-care SAMBA II SARS-CoV-2 Test for detection of SARS-CoV-2

2020 ◽  
Author(s):  
Sonny M Assennato ◽  
Allyson V Ritchie ◽  
Cesar Nadala ◽  
Neha Goel ◽  
Hongyi Zhang ◽  
...  
Keyword(s):  
Public Health ◽  
Infection Control ◽  
Sensitivity And Specificity ◽  
Patient Management ◽  
Limit Of Detection ◽  
Point Of Care ◽  
Clinical Samples ◽  
Analytical Sensitivity ◽  
Point Of Care Testing ◽  
Clinical Sensitivity

AbstractNucleic acid amplification for the detection of SARS-CoV-2 RNA in respiratory samples is the standard method for diagnosis. These tests are centralised and therefore turnaround times can be 2-5 days. Point-of-care testing with rapid turnaround times would allow more effective triage in settings where patient management and infection control decisions need to be made rapidly.Inclusivity and specificity of the SAMBA II SARS-CoV-2 assay was determined by in silico analyses of the primers and probes. Analytical and clinical sensitivity and specificity of the SAMBA II SARS-CoV-2 Test was evaluated for analytical sensitivity and specificity. Clinical performance was evaluated in residual clinical samples compared to the Public Health England reference tests.The limit of detection of the SAMBA II SARS-CoV-2 Test is 250 cp/mL and is specific for detection of 2 regions of the SARS-CoV-2 genome. The clinical sensitivity was evaluated in 172 clinical samples provided by the Clinical Microbiology and Public Health Laboratory, Addenbrooke’s Hospital, Cambridge (CMPHL), which showed a sensitivity of 98.9% (95% CI 94.03-99.97%), specificity of 100% (95% CI 95.55-100%), PPV of 100% and NPV of 98.78% (92.02-99.82%) compared to testing by CMPHLSAMBA detected 3 positive samples that were initially negative by PHE Test. The data shows that the SAMBA II SARS-CoV-2 Test performs equivalently to the centralised testing methods with a much quicker turnaround time. Point of care testing, such as SAMBA, should enable rapid patient management and effective implementation of infection control measures.

scholarly journals Rapid, sensitive and specific SARS coronavirus-2 detection: a multi-center comparison between standard qRT-PCR and CRISPR based DETECTR.

2020 ◽  
Author(s):  
Eelke Brandsma ◽  
Han JMP Verhagen ◽  
Thijs J.W. van de Laar ◽  
Eric C.J. Claas ◽  
Marion Cornelissen ◽  
...  
Keyword(s):  
Point Of Care ◽  
Diagnostic Testing ◽  
Added Value ◽  
N Gene ◽  
Analytical Sensitivity ◽  
Qrt Pcr ◽  
Negative Results ◽  
Point Of Care Test ◽  
Ribonucleoprotein Complexes ◽  
Large Patient

Recent advances in CRISPR-based diagnostics suggest that DETECTR, a combination of isothermal reverse transcriptase loop mediated amplification (RT-LAMP) and subsequent Cas12 bystander nuclease activation by amplicon targeting ribonucleoprotein complexes, could be a faster and cheaper alternative to qRT-PCR without sacrificing sensitivity/specificity. Here we compare qRT-PCR with DETECTR to diagnose COVID-19 on 378 patient samples and report a 95% reproducibility. Patient sample dilution assays suggest a higher analytical sensitivity of DETECTR compared to qRT-PCR, however, this was not confirmed in a large patient cohort. The data showed that both techniques are equally sensitive in detecting SARS-CoV-2 providing an added value of DETECTR to the currently used qRT-PCR platforms. For DETECTR, different gRNAs can be used simultaneously to obviate negative results due to mutations in N-gene. Lateral flow strips, suitable as a point of care test (POCT), showed a 100% correlation to the high-throughput DETECTR assay. Importantly, DETECTR was 100% specific for SARS-CoV-2 and did not detect other human coronaviruses. As there is no need for specialized equipment, DETECTR could be rapidly implemented as a complementary technically independent approach to qRT-PCR thereby increasing the testing capacity of medical microbiological laboratories and relieving the existent PCR-platforms for routine non- SARS-CoV-2 diagnostic testing.

Building a Public-Private Partnership to Enhance Laboratory Preparedness and Response in the United States

2020 ◽  
pp. 1-4 ◽  
Author(s):  
Reynolds M. Salerno ◽  
Jasmine Chaitram ◽  
Joanne D. Andreadis
Keyword(s):  
Public Health ◽  
Clinical Laboratory ◽  
Diagnostic Testing ◽  
Health Sector ◽  
High Volume ◽  
The United States ◽  
Public Health Emergency ◽  
Public Health Response ◽  
The Public ◽  
Communication And Coordination

ABSTRACT The public health community has recognized that it cannot handle responses to all possible public health emergencies on its own. The public health sector has deep scientific expertise and excels at initial identification, complex characterization, and test development. The private sector has many resources and capabilities that can complement and augment the public health response. This is especially true in the clinical laboratory sector. Many commercial laboratories are designed for high-volume, high-throughput diagnostic testing in a way that public health laboratories are not. Significant steps have been taken since 2017 to improve the communication and coordination between public health and the private clinical laboratory community, especially during a response to a public health emergency. This paper describes the strong foundation that has been built for an improved clinical and public health laboratory response to the next public health emergency.

scholarly journals Towards effective diagnostic assays for COVID-19: a review

2020 ◽  
Vol 73 (7) ◽  
pp. 370-377 ◽  
Author(s):  
Marietjie Venter ◽  
Karin Richter
Keyword(s):  
Point Of Care ◽  
Case Definition ◽  
Molecular Diagnostic ◽  
Public Health Response ◽  
Serological Tests ◽  
Diagnostic Assays ◽  
Laboratory Capacity ◽  
Health Response ◽  
The Usa ◽  
Antigen Tests

Countries globally are affected by the COVID-19 pandemic, with nearly two million cases and 120 000 deaths occurring within 4 months of the discovery of the severe acute respiratory syndrome coronavirus-2 in December 2019 in China. Accurate diagnoses of cases is key in managing the pandemic by identification, isolation and treatment of patients and defining the epidemiology of the virus. By mid-January 2020, a scientist from China published the full genome of the virus, which facilitated the development of accurate molecular diagnostic assays. By the end of January 2020, the WHO, in collaboration with laboratories in Asia, Europe and the USA, published several real-time reverse transcriptase PCR (rtRT-PCR) protocols that allowed identification of cases and development of commercial assays. Clinical investigations facilitated development of accurate case definition and guidance for laboratories on the optimum specimens and procedures for diagnoses. Currently, laboratory-based rtRT-PCR is the recommended test for diagnoses of acute cases to ensure patients can be identified and isolated and to facilitate the public health response. However, due to delays in diagnoses, severe shortage of tests and laboratory capacity, point-of-care molecular or antigen tests are becoming more attractive. Although serological tests are not suitable for diagnoses of acute cases, they are important to define epidemiological questions, including attack rate in the population, and to identify immune individuals. This review aimed to summarise the current available information for diagnoses of cases and to aid laboratories and healthcare workers to select the best assays and procedures.

scholarly journals Performance Evaluation of the SAMBA II SARS-CoV-2 Test for Point-of-Care Detection of SARS-CoV-2

2020 ◽  
Vol 59 (1) ◽  
pp. e01262-20 ◽  
Author(s):  
Sonny M. Assennato ◽  
Allyson V. Ritchie ◽  
Cesar Nadala ◽  
Neha Goel ◽  
Cuijuan Tie ◽  
...  
Keyword(s):  
Public Health ◽  
Infection Control ◽  
Patient Management ◽  
Clinical Performance ◽  
Point Of Care ◽  
Turnaround Time ◽  
Control Measures ◽  
Nucleic Acid Amplification ◽  
Analytical Sensitivity ◽  
Percent Agreement

ABSTRACTNucleic acid amplification for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA in respiratory samples is the standard method for diagnosis. The majority of this testing is centralized and therefore has turnaround times of several days. Point-of-care (POC) testing with rapid turnaround times would allow more effective triage in settings where patient management and infection control decisions need to be made rapidly. The inclusivity and specificity of the Simple AMplification-Based Assay (SAMBA) II SARS-CoV-2 test were determined by both in silico analyses of the primers and probes and wet testing. The SAMBA II SARS-CoV-2 test was evaluated for performance characteristics. Clinical performance was evaluated in residual combined throat/nose swabs and compared to that of the Public Health England real-time PCR assay targeting the RdRp gene. The SAMBA II SARS-CoV-2 test has an analytical sensitivity of 250 copies/ml for detecting two regions of the genome (open reading frame 1ab [ORF1ab] and nucleocapsid protein [N]). The clinical performance was evaluated in 172 residual combined nose/throat swabs provided by the Clinical Microbiology and Public Health Laboratory, Addenbrooke’s Hospital, Cambridge (CMPHL), which showed an estimated positive percent agreement of 98.9% (95% confidence interval [CI], 93.83 to 99.97) and negative percent agreement of 96.4% (95% CI, 89.92 to 99.26) compared to testing by the CMPHL. The data show that the SAMBA II SARS-CoV-2 test performs equivalently to the centralized testing methods, but with a shorter turnaround time of 86 to 101 min. Point-of-care tests such as SAMBA should enable rapid patient management and effective implementation of infection control measures.

scholarly journals COVID-19 Antigen Rapid Test as Screening Strategy at the Points-of-Entry: Experience in Lazio Region, Central Italy, August-October 2020

2020 ◽  
Author(s):  
Francesca Colavita ◽  
Francesco Vairo ◽  
Silvia Meschi ◽  
Beatrice Valli ◽  
Eleonora Lalle ◽  
...  
Keyword(s):  
Public Health ◽  
Point Of Care ◽  
Central Italy ◽  
Rapid Test ◽  
Lower Sensitivity ◽  
Molecular Testing ◽  
Early Screening ◽  
Public Health Response ◽  
Lazio Region ◽  
The Public

AbstractCOVID-19 pandemic is becoming one of the most dramatic health, social and economic global challenges in recent history. Testing is one of the main components of the public health response to contain the virus spreading. There is an urgent need to expand testing capacity and antigen rapid tests (Ag RDT) represent good candidates for point-of-care and mass surveillance testing to rapidly identify people with SARS-CoV-2 infection, counterbalancing lower sensitivity as compared to the gold standard molecular tests with timeliness of results and possibility of recurred testing. Here, we report preliminary data of the testing algorithm implemented at the points-of-entry (airports and port) in Lazio Region (Central Italy) on travelers arriving between 17th of August to 15th of October, 2020, using the STANDARD F COVID-19 Antigen Fluorescence ImmunoAssay. Our findings show that the probability of molecular confirmation of Ag RDT positive results is directly dependent from the semi-quantitative results of this Ag RDT, and that the molecularly confirmed samples actually harbor infectious virus. These results support the public health strategies based on early screening campaigns in settings where molecular testing is not feasible or easily accessible, using rapid and simple point of care tests, able to rapidly identify those subjects who are at highest risk of spreading SARS-CoV-2 infection.

scholarly journals Evaluation of the Abbott BinaxNOW COVID-19 Test Ag Card for rapid detection of SARS-CoV-2 infection by a local public health district with a rural population

PLoS ONE ◽  
2021 ◽  
Vol 16 (12) ◽  
pp. e0260862
Author(s):  
Rachel E. Pollreis ◽  
Clay Roscoe ◽  
Rachel J. Phinney ◽  
Surabhi S. Malesha ◽  
Matthew C. Burns ◽  
...  
Keyword(s):  
Public Health ◽  
Rural Communities ◽  
Predictive Value ◽  
Diagnostic Testing ◽  
High Specificity ◽  
The United States ◽  
Health District ◽  
Rt Pcr ◽  
Local Public Health ◽  
Antigen Tests

SARS-CoV-2 RT-PCR, the gold standard for diagnostic testing, may not be readily available or logistically applicable for routine COVID-19 testing in many rural communities in the United States. In this validation study, we compared the BinaxNOW™ COVID-19 Test Ag Card with SARS-CoV-2 RT-PCR in 214 participants who sought COVID-19 testing from a local public health district in Idaho, USA. The median age of participants was 35 and 82.7% were symptomatic. Thirty-seven participants (17.3%) had positive RT-PCR results. Results between the two tests were 94.4% concordant. The sensitivity of the BinaxNOW™ COVID-19 Test Ag Card was 67.6% (95% CI: 50.2–81.9%), and the specificity was 100.0% (95% CI: 97.9–100.0%). The positive predictive value (PPV) for the BinaxNOW™ COVID-19 Test Ag Card was 100.0% (95% CI: 86.2–100.0%), and the negative predictive value (NPV) was 93.6% (95% CI: 89.1–96.6%). Although the sensitivity of BinaxNOW™ COVID-19 Test Ag Card was lower than RT-PCR, rapid results and high specificity support its use for early detection of COVID-19, especially in settings where SARS-CoV-2 RT-PCR testing is not readily available. Rapid antigen tests, such as the BinaxNOW™ COVID-19 Test Ag Card, may be a more convenient tool in quickly identifying and preventing COVID-19 transmission, especially in rural settings.

scholarly journals Partnerships Involved in Public Health Testing for Zika Virus in Florida, 2016

2019 ◽  
Vol 134 (2_suppl) ◽  
pp. 43S-52S ◽  
Author(s):  
Lea Heberlein-Larson ◽  
Leah D. Gillis ◽  
Andrea Morrison ◽  
Blake Scott ◽  
Mary Cook ◽  
...  
Keyword(s):  
Public Health ◽  
Zika Virus ◽  
Diagnostic Testing ◽  
Lessons Learned ◽  
Public Health Response ◽  
Peak Period ◽  
Adverse Health Outcomes ◽  
Commercial Laboratory ◽  
Laboratory Capacity ◽  
Control And Prevention

The emergence of Zika virus in the Americas in 2015 and its association with birth defects and other adverse health outcomes triggered an unprecedented public health response and a demand for testing. In 2016, when Florida exceeded state public health laboratory capacity for diagnostic testing, the state formed partnerships with federal and commercial laboratories. Eighty-two percent of the testing (n = 33 802 of 41 008 specimens) by the laboratory partners, including Florida’s Bureau of Public Health Laboratories (BPHL; n = 13 074), a commercial laboratory (n = 19 214), and the Centers for Disease Control and Prevention (CDC; n = 1514), occurred from July through November 2016, encompassing the peak period of local transmission. These partnerships allowed BPHL to maintain acceptable test turnaround times of 1 to 4 days for nucleic acid testing and 3 to 7 days for serologic testing. Lessons learned from this response to inform future outbreaks included the need for early planning to establish outside partnerships, adding specimen triage strategies to surge plans, and integrating state and CDC information systems.

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