COVID-19 Testing and Diagnostics: A Review of Commercialized Technologies for Cost, Convenience and Quality of Tests

Abstract

Population-scale and rapid testing for SARS-CoV-2 continues to be a priority for several parts of the world. We revisit the in vitro technology platforms for COVID-19 testing and diagnostics—molecular tests and rapid antigen tests, serology or antibody tests, and tests for the management of COVID-19 patients. Within each category of tests, we review the commercialized testing platforms, their analyzing systems, specimen collection protocols, testing methodologies, supply chain logistics, and related attributes. Our discussion is essentially focused on test products that have been granted emergency use authorization by the FDA to detect and diagnose COVID-19 infections. Different strategies for scaled-up and faster screening are covered here, such as pooled testing, screening programs, and surveillance testing. The near-term challenges lie in detecting subtle infectivity profiles, mapping the transmission dynamics of new variants, lowering the cost for testing, training a large healthcare workforce, and providing test kits for the masses. Through this review, we try to understand the feasibility of universal access to COVID-19 testing and diagnostics in the near future while being cognizant of the implicit tradeoffs during the development and distribution cycles of new testing platforms.

A Scoping Review of Supply Chain Management Systems for Point of Care Diagnostic Services: Optimising COVID-19 Testing Capacity in Resource-Limited Settings

“…The eligible studies were published between 2011 and 2021. The 31 articles included 15 reviews [ 10 , 12 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 ], 1 website of an international organisation [ 33 ], 2 randomised controlled trials [ 34 , 35 ], 1 cross-sectional study [ 36 ], 1 case study [ 37 ], 1 cohort study [ 38 ] and 10 studies that used mixed method approaches ranging from focus group discussions to interviews to direct observations [ 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 ]. The included articles presented evidence of research conducted in the following countries: Mozambique [ 34 , 36 , 44 ], Zimbabwe [ 49 ], Ghana [ 12 , 21 , 22 , 40 , 45 , 48 ], Malawi [ 42 ], Namibia [ 41 ], India [ 43 ], Sierra Leone [ 37 ], Burkina Faso [ 38 ], The Philippines [ ...…”

“…Evidence on the following POC diagnostic tests were provided: COVID-19 [ 27 , 28 , 33 ]; HIV [ 10 , 12 , 22 , 23 , 24 , 25 , 26 , 34 , 36 , 42 , 49 ]; malaria [ 10 , 12 , 22 , 23 , 34 , 35 , 38 , 40 , 41 , 43 , 44 , 46 , 47 , 48 ]; syphilis [ 10 , 12 , 23 , 32 , 34 , 39 , 42 , 45 ]; tuberculosis [ 30 , 31 ] and others comprising of anaemia [ 34 , 40 ], UTI [ 37 ], diabetes [ 12 , 31 ], blood glucose [ 22 ], preeclampsia urinalysis [ 37 ], urine pregnancy [ 22 ], urine protein [ 22 , 34 ], haemoglobin [ 22 ], dyslipidaemia […”

“…The eligible studies provided evidence on at least one aspect of the SCM system. The aspects of the SCM systems covered were procurement and stockouts [ 10 , 12 , 21 , 24 , 25 , 26 , 33 , 34 , 36 , 41 , 42 , 43 , 44 , 45 , 47 , 49 ], quality assurance [ 10 , 23 , 24 , 27 , 29 , 31 , 32 , 37 , 46 , 48 , 49 ], safe disposal [ 46 ], inventory management [ 10 , 12 , 21 , 25 , 35 , 36 ], selection [ 10 , 22 , 28 , 33 , 46 ], distribution [ 12 , 21 , 22 , 34 , 38 , 41 , 48 ], quantification [ 12 ], storage [ 12 , 21 , …”

Highly Sensitive Immunoresistive Sensor for Point-Of-Care Screening for COVID-19

“…These reported levels are not sensitive enough to detect the target virus in nasal swab samples at an early stage of infection where the viral load can be lower than 100 copies/mL, according to a clinical study [15]. Immunoglobulin tests detecting Immunoglobulin G (IgG) or Immunoglobulin M (IgM) lack specificity, do not respond to early-stage infection, and may produce false positives for the vaccinated population [16][17][18]. Other detection methods are more promising in accuracy and screening time.…”

Advanced CRISPR-Cas Effector Enzyme-Based Diagnostics for Infectious Diseases, Including COVID-19

“…Immunoassays for infectious diseases are widely used to detect pathogen-associated antigens or antibodies against pathogens in patient serum. Although these assays are relatively simple to perform and require a short turnaround time, they are relatively insensitive, making it difficult to evaluate clinical samples containing low concentrations of target molecules [1][2][3]. Moreover, because several days are needed for patients to make sufficient concentrations of antigens or antibodies to be detected by these assays, they are not suitable for early diagnosis.…”