Is nucleic acid amplification point-of-care testing for chlamydia and gonorrhoea cost-effective?

Abstract Background Group A streptococcal (GAS) pharyngitis is common in the United States (US). Each year, approximately 12 million people seek medical care for pharyngitis, accounting for ~2% of ambulatory care visits. The gold standard method for diagnosing GAS is culture. However, because culture is time intensive, rapid antigen detection tests (RADTs), with or without culture confirmation, are commonly used. Although RADTs provide results quickly, test sensitivity has been shown to be sub-optimal, which can lead to inappropriate treatment decisions. Recently, highly sensitive point-of-care nucleic acid amplification tests (POC NAAT), such as the cobas® Liat® System, have emerged. The objective of this study was to evaluate the cost-effectiveness (CE) and budget impact (BI) of adopting POC NAAT compared with RADT+culture confirmation to diagnose GAS pharyngitis from the US third-party payer perspective. Methods A decision-tree economic model was developed in Microsoft Excel to quantify costs and clinical outcomes associated with POC NAAT and RADT+culture over a one-year period. All model inputs were derived from published literature and public databases. Model outputs included costs and clinical effects measured as quality-adjusted life days (QALDs) lost. One-way and probabilistic sensitivity analyses were performed to assess the impact of uncertainty on results. Results CE analysis showed that POC NAAT would cost $44 per patient compared with $78 with RADT+ culture. POC NAAT was associated with fewer QALDs lost relative to RADT+ culture. Therefore, POC NAAT may be considered the “dominant” strategy (i.e., lower costs and higher effectiveness). Findings were robust in sensitivity analyses. BI analysis showed that adopting POC NAAT for diagnosis of GAS could yield cost-savings of 0.3% vs. current budget over 3 years. This is due to savings associated with testing, GAS-related complications, antibiotic treatment and treatment-associated complication costs. Conclusion Results suggest that adopting POC NAAT to diagnose GAS would be considered cost-effective and yield cost-savings for US payers relative to RADT+culture. Access to POC NAAT would be important to optimize appropriate GAS diagnosis and treatment decisions. Disclosures All authors: No reported disclosures.

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Paper-based point-of-care testing for cost-effective diagnosis of acute dengue infections

Journal of Clinical Virology ◽

10.1016/j.jcv.2016.08.100 ◽

2016 ◽

Vol 82 ◽

pp. S51

Author(s):

F. Bedin ◽

E. Voilin ◽

L. Boulet ◽

G. Theillet ◽

A. Perrin ◽

...

Keyword(s):

Point Of Care ◽

Cost Effective ◽

Point Of Care Testing ◽

Effective Diagnosis

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Quality Management for Point-Of-Care Testing of Pathogen Nucleic Acids: Chinese Expert Consensus

Frontiers in Cellular and Infection Microbiology ◽

10.3389/fcimb.2021.755508 ◽

2021 ◽

Vol 11 ◽

Author(s):

Xi Mo ◽

Xueliang Wang ◽

Zhaoqin Zhu ◽

Yuetian Yu ◽

Dong Chang ◽

...

Keyword(s):

Public Health ◽

Nucleic Acid ◽

Quality Management ◽

Clinical Laboratory ◽

Point Of Care ◽

Conventional Polymerase Chain Reaction ◽

Laboratory Medicine ◽

Expert Consensus ◽

Nucleic Acid Detection ◽

Point Of Care Testing

COVID-19 continues to circulate globally in 2021, while under the precise policy implementation of China’s public health system, the epidemic was quickly controlled, and society and the economy have recovered. During the pandemic response, nucleic acid detection of SARS-CoV-2 has played an indispensable role in the first line of defence. In the cases of emergency operations or patients presenting at fever clinics, nucleic acid detection is required to be performed and reported quickly. Therefore, nucleic acid point-of-care testing (POCT) technology for SARS-CoV-2 identification has emerged, and has been widely carried out at all levels of medical institutions. SARS-CoV-2 POCT has served as a complementary test to conventional polymerase chain reaction (PCR) batch tests, thus forming an experimental diagnosis platform that not only guarantees medical safety but also improves quality services. However, in view of the complexity of molecular diagnosis and the biosafety requirements involved, pathogen nucleic acid POCT is different from traditional blood-based physical and chemical index detection. No guidelines currently exist for POCT quality management, and there have been inconsistencies documented in practical operation. Therefore, Shanghai Society of Molecular Diagnostics, Shanghai Society of Laboratory Medicine, Clinical Microbiology Division of Shanghai Society of Microbiology and Shanghai Center for Clinical Laboratory have cooperated with experts in laboratory medicine to generate the present expert consensus. Based on the current spectrum of major infectious diseases in China, the whole-process operation management of pathogen POCT, including its application scenarios, biosafety management, personnel qualification, performance verification, quality control, and result reporting, are described here. This expert consensus will aid in promoting the rational application and robust development of this technology in public health defence and hospital infection management.

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Point-of-Care Diagnostic Tools for Surveillance of SARS-CoV-2 Infections

Frontiers in Public Health ◽

10.3389/fpubh.2021.766871 ◽

2021 ◽

Vol 9 ◽

Author(s):

Dhanasekaran Sakthivel ◽

David Delgado-Diaz ◽

Laura McArthur ◽

William Hopper ◽

Jack S. Richards ◽

...

Keyword(s):

Large Scale ◽

Clinical Symptoms ◽

Point Of Care ◽

Cost Effective ◽

Nucleic Acid Amplification ◽

Diagnostic Tools ◽

Rt Pcr ◽

Serological Tests ◽

Polymerase Chain ◽

Effective Public Health

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is a recently emerged and highly contagious virus that causes coronavirus disease 2019 (COVID-19). As of August 24, 2021, there were more than 212 million confirmed COVID-19 cases and nearly 4.4 million deaths reported globally. Early diagnosis and isolation of infected individuals remains one of the most effective public health interventions to control SARS-CoV-2 spread and for effective clinical management of COVID-19 cases. Currently, SARS-CoV-2 infection is diagnosed presumptively based on clinical symptoms and confirmed by detecting the viral RNA in respiratory samples using reverse transcription polymerase chain reaction (RT-PCR). Standard RT-PCR protocols are time consuming, expensive, and technically demanding, which makes them a poor choice for large scale and point-of-care screening in resource-poor settings. Recently developed isothermal nucleic acid amplification tests (iNAAT), antigen and/or serological tests are cost-effective to scale COVID-19 testing at the point-of-care (PoC) and for surveillance activities. This review discusses the development of rapid PoC molecular tools for the detection and surveillance of SARS-CoV-2 infections.

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Evaluation of the Visby Medical COVID-19 Point of Care Nucleic Acid Amplification Test

Clinical Biochemistry ◽

10.1016/j.clinbiochem.2021.11.007 ◽

2021 ◽

Author(s):

Brooke M. Katzman ◽

Amy M. Wockenfus ◽

Brandon R. Kelley ◽

Brad S. Karon ◽

Leslie J. Donato

Keyword(s):

Nucleic Acid ◽

Point Of Care ◽

Nucleic Acid Amplification Test ◽

Nucleic Acid Amplification

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Rapid direct nucleic acid amplification test without RNA extraction for SARS-CoV-2 using a portable PCR thermocycler

10.1101/2020.04.17.042366 ◽

2020 ◽

Cited By ~ 9

Author(s):

Soon Keong Wee ◽

Suppiah Paramalingam Sivalingam ◽

Eric Peng Huat Yap

Keyword(s):

Nucleic Acid ◽

Reverse Transcription ◽

Rna Extraction ◽

Cost Effective ◽

Turnaround Time ◽

Nucleic Acid Amplification ◽

Detection Methods ◽

N Gene ◽

Direct Pcr ◽

Viral Lysis

There is an ongoing worldwide coronavirus disease 2019 (Covid-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). At present, confirmatory diagnosis is by reverse transcription polymerase chain reaction (RT-PCR), typically taking several hours and requiring a molecular laboratory to perform. There is an urgent need for rapid, simplified and cost-effective detection methods. We have developed and analytically validated a protocol for direct rapid extraction-free PCR (DIRECT-PCR) detection of SARS-CoV-2 without the need for nucleic acid purification. As few as 6 RNA copies per reaction of viral nucleocapsid (N) gene from respiratory samples such as sputum and nasal exudate can be detected directly using our one-step inhibitor-resistant assay. The performance of this assay was validated on a commercially available portable PCR thermocycler. Viral lysis, reverse transcription, amplification and detection are achieved in a single-tube homogeneous reaction within 36 minutes. This minimized hands-on time, reduces turnaround-time for sample-to-result and obviates the need for RNA purification reagents. It could enable wider use of Covid-19 testing for diagnosis, screening and research in countries and regions where laboratory capabilities are limiting.

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