Detection Methods Used Currently by Manufacturers

(Please indicate "current" date if not stated elsewhere)

- CDC
- WHO

Detection Methods Used Currently by Organizations

Imaging tests cannot be used as the only reliable diagnostic tool to detect infection due to its lack of sensitivity. However, it can be useful in medical settings with limited resources where the virus is prevalent.

- Chest Radiograph
- Ultrasound
- Computed Tomography

Radiographics Test / CT Imaging for COVID-19

The use of antibody-testing with a similar sensitivity and specificity to RT-PCR. However, the virus is detected in a later state (10-20 days into the infection). 
- SVN
- ELISA
- LFIA


Biomarkers

Nucleic acid amplification tests (NAAT) are diagnostic methods in molecular biology used to identify viruses in patient specimens by detecting unique viral nucleic acid sequences. These tests work by amplifying specific segments of viral DNA or RNA, enabling the confirmation and identification of the target virus.

NAAT

No single diagnostic test is entirely sufficient for diagnosing an active viral infection before death. The accuracy of these assays depends on their detection sensitivity, the quantity of virions present in the sample, and the timing of the test relative to viral shedding, which can vary. Consequently, a negative test result does not definitively rule out an infection, as viral loads may simply be too low at the time of sampling, often requiring repeated testing over time to ensure detection.

Limitations of Viral Diagnostic Testing

Smith College

University of California, Santa Cruz

Key Features of Diagnostic Testing and Sampling

Specificity measures the ability for the test to produce a correct negative result for people who don't have a given condition.
ex) A test with a 80% sensitivity will return a correct positive result 85% of the time, but a a false negative 15% percent of the time.

Specificity in Testing

Biomedical engineers have put in extensive time and research in testing methods and diagnostics regarding the novel coronavirus. The test results of the population have provided mathematical models to visualize the pandemic, alternatively the private sector has produced a high-volume of nasopharyngeal, throat, and nasal test kits by bioengineering front-runners including: Abbot, Xpert, Lightmix, and Genmark.

Diagnostics and Testing with Biomedical Engineering

Sensitivity is a measure of how often a "true positive" result is produced. A test with a sensitivity of 85% will produce a "true positive" 85% and a false negative 15% of the time.

Sensitivity of Testing

Dcruz, R. J., Currier, A. W., & Sampson, V. B. (2020). Laboratory Testing Methods for Novel Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2). Frontiers in Cell and Developmental Biology, 8. doi:10.3389/fcell.2020.00468

Frontiers in Cell and Developmental Biology

Cheng MP, Papenburg J, Desjardins M, et al. Diagnostic Testing for Severe Acute Respiratory Syndrome-Related Coronavirus 2: A Narrative Review. Ann Intern Med. 2020;172(11):726-734. doi:10.7326/M20-1301

https://pubmed.ncbi.nlm.nih.gov/32282894/

Diagnostic Testing for Severe Acute Respiratory Syndrome-Related Coronavirus 2

- Isothermal Nucleic Acid Amplification
- RPA
- CRISPR
- Cas13a Assay
- Next Generation Sequencing 
- Nanomaterials (nanotrap particles, etc.)
- Wondfo Qualitative Rapid Chromatographic Immunoassay (RCI)

Emerging Methods for Diagnosis of SARS-CoV-2

Machine Learning models can be used to better understand the proteins and complexes that are incvolved with the novel Coronavirus. This includes producing predictions of pandemic regarding hospitalizations, patient outcomes, and simulations.

Machine Learning Analysis 

Sample Collection Methods for Diagnosis

- A reduction of ADAMTS13 levels can potentially predict mortality risk for patients infected with SARS-CoV-2

Potential Diagnostic Methods for COVID-19 Mortality Prediction  

Weekly surveillance testing along with isolation would more effectively limit COVID-19 outbreaks than the slow and expensive (yet precise) qPCR (quantitative polymerase chain reaction) testing method that is currently employed.

Testing Strategy for Controlling COVID-19 Outbreaks

In August, the CDC officially recommended that those without COVID-19 symptoms didn't need to be tested- even if they knew they'd been exposed. This decision received a lot of backlash from public health officials pushing for more testing.  It was later revealed that that the original guidelines had been re-written by those involved with the Department of Health and Human Services and the US COVID task force.

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