Consumer Product Testing Work Spans Disease Diagnostics, Pharmaceuticals, Drug Detection, and More
As a contract research organization (CRO) with a history of important breakthroughs in disease diagnostics, pharmaceutical science, and medical research, we are often tasked with addressing challenges at the forefront of scientific research – including consumer product testing.
Because no two challenges are the same, our role is to adapt and seek solutions based on our customer’s varied needs. In some cases, this includes developing the processes and procedures to assess whether their consumer product claims stand up to scientific rigor.
While some of the testing and evaluation we conduct assesses consumer product sustainability or longevity, our focus is most often on product efficacy, or understanding how effective a product is at achieving its stated purpose. Following an unbiased and independent assessment of product performance, our customers can know whether their product works as intended and will have the scientific research data to prove it, while consumers can feel confident knowing that the product they use is working to its intended purpose.
Experts in their various fields, the majority of our researchers leading our consumer product testing programs and working in our testing laboratories have a Ph.D. in a life science field, while others have education in related fields. These include aerobiologists, microbiologists, cell biologists, virologists, and others. Their work partnering with our customers and reporting research results offers those customers insights into the research design and findings that other CROs do not.
While our consumer product testing and evaluation work spans many disciplines, MRIGlobal’s commitment to providing world-class expertise, service, and laboratories is consistent and unmatched. Following is a sampling of six recent consumer product testing and evaluation programs we have led.
Improving COVID-19 Diagnostics – Evaluating Rapid Test Performance
Polymerase chain reaction (PCR) is the gold standard for many diagnostic assays due to its extreme sensitivity and specificity. However, PCR tests generally require skilled personnel and specialized equipment to perform the tests, and are more expensive than rapid test alternatives. Conversely, lateral flow immunoassay antigen tests are rapid, relatively inexpensive, and can be performed by untrained personnel at the point of care or even in the home – similar to the function of an at-home pregnancy test, these are the at-home tests for COVID-19 we’ve all become far too familiar with these past few years.
When a sample is added to a lateral flow assay, it will first flow through the device’s conjugate pad. The conjugate pad contains antibodies specific for the target antigen (in this case, SARS-CoV2 nucleocapsid protein) – the antibodies in the conjugate pad are labeled with a visualization tag, such as gold nanoparticles. If the target antigen is present in the sample, the labeled antibodies will bind to that target. As the sample continues to flow through the membrane, it encounters a line of immobilized antibodies which are also specific for the target antigen (the test line). If target antigen is present in the sample, it accumulates at the test line, and the test line becomes visible as a colored line due to the associated accumulation of the labeled antibodies, which are also bound to the target antigen. The appearance of a colored test line indicates the presence of the target and thus a positive test for the consumer. As the sample continues to flow through the membrane, a second line will appear as a control, indicating the test was performed successfully. Unfortunately, rapid antigen tests are generally less sensitive than PCR, which can result in false-negative or weak positive results.
Antigen tests have not traditionally matched the sensitivity reported by PCR tests in part because they lack the target amplification that occurs during PCR. It has been shown that PCR-level sensitivity can be approached by an antigen test using signal amplification technologies such as enhanced electrochemiluminescence. The sensitivity of rapid lateral flow antigen tests can also be enhanced by using a fluorescent antibody label coupled with an appropriately designed reader, eliminating subjectivity that can occur with a visually interpreted test and providing a more definitive test result. The drawback in using fluorescent reporters is that they cannot be visualized by the human eye and therefore require a reader with a light source for excitation and a camera for measuring the fluorescence emission intensity of the test and control lines. In addition to potentially offering greater sensitivity, the use of a reader provides an opportunity to seamlessly compile results into an electronic database for reporting and surveillance purposes, critical for understanding the trajectory of a disease and influencing pandemic response decisions.
Because of their ease-of-use for consumers and their benefits to public health, there is a critical need to increase the sensitivity of rapid antigen tests and ensure consumers can accurately read their results.
MRIGlobal scientists performed comparison testing to support the development of a novel reader for lateral flow immunoassays. To read the entire research report, visit “Halo—A Universal Fluorescence Reader Based Threat Agent Detection Platform—A Proof of Concept Study Using SARS-CoV-2 Assays” at Frontiersin.org.
Lateral flow readers offer a low-cost solution with the ability to read results that humans otherwise cannot and also facilitate reporting due to their cloud connectivity. With the evolution of different virus strains, testing will undoubtedly be necessary for the foreseeable future. Tools that can provide accurate results in a timely manner can be useful in providing critical information in a variety of settings including homes, schools, and clinics. In addition to standard fluorescent samples, such readers can also be adjusted to perform sophisticated delayed luminescence measurements as well as read colorimetric assays, all with an extremely low total cost. By simply swapping the label used for the diagnostic, any assay from any provider can in principle be rendered compatible with the system. They can also be modified for potential multiplex application using different fluorescent reporters and multiple test lines.
Moreover, data from an electronically read, sensitive lateral flow assay can be combined with PCR assay data to make reasonable calls on infectivity and make more informed public health decisions early in the infection cycle. Similarly, sensitive assays such as the one described here can be a good test for use in monitoring individuals during the infectious period. The ease of use of the lateral flow test, coupled with the increased sensitivity of the reader and the objectivity of the test results, provides a strong public health benefit.
Assessment of Antiviral Material Against SARS-CoV-2
The emergent threat of COVID-19 infection and high rate of transmission associated with severe illness and fatalities created a severe threat to healthcare personnel, first responders, and general populations worldwide. This prompted the need for rapid development of effective Personal Protective Equipment (PPE) and disinfection methods. In response, our team tested and evaluated a client’s novel antiviral fabric against SARS-CoV-2.
Testing Removal of SARS-CoV-2 from the Air
Anyone working in enclosed spaces, such as healthcare personnel, first responders, and general populations worldwide are susceptible to the severe threat of COVID-19 infection and high rate of transmission. As a result, the pandemic has brought about a need for rapid development of effective methods to remove SARS-CoV-2 virus from the air in enclosed environments.
Testing to Support 510(k) Approvals
Much of our recent diagnostic device and assay testing has been to assist customers with their work to move diagnostic devices through the Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) process, enabling temporary market access. Today, those same customers are interested in achieving permanent market access through the FDA’s 510(k) approval process. To do so, we provide them the space, instrumentation, and expertise of our team to facilitate the process and potentially gain market access for their consumer products.
Pharmaceutical Stability Testing
Stability studies are used to generate evidence on how the quality of a drug substance or formulated drug product varies with time under the influence of a variety of environmental factors. These studies help determine the shelf life, purity, and storage needs for pharmaceuticals prior to commercial approval and ensure that the integrity of the active ingredient is safe for distribution. Our Pharmaceutical Sciences group has supported shelf-life stability testing for over 50 years and our world-class team of highly experienced scientists make use of modern facilities, equipment, and instrumentation to fully support ICH compliant stability testing.
High-quality active pharmaceutical ingredients (APIs) are core to the manufacturing of safe and effective drugs. MRIGlobal’s Pharmaceutical Sciences portfolio encompasses a broad range of flexible capabilities in the API market. We have extensive experience in analytical method development, validation (preclinical through commercial), characterization/release testing and stability testing. With our stability testing for API synthesis, we are able to observe the product in a variety of conditions and over varying lengths of time to monitor any change in the quality of the API.
Drug Detection Kit Testing
A variety of alcohol, drugs, tranquilizers, and antidepressants can be used in an effort to commit sexual assault crimes. Drug detection kits are supposed to help alert people whether their drink has been spiked, but they don’t always work as advertised. To better understand their efficacy, we evaluated six commercially available colorimetric kits, testing them against GHB, ketamine, diazepam, alprazolam (commercially marketed as Xanax), and flunitrazepam (commercially marketed as Rohypnol). These are some of the drugs most commonly used in relation to these crimes.
GETTING STARTED AT MRIGLOBAL
Contact MRIGlobal to further understand our work in consumer product testing. Whether disease diagnostics, pharmaceutical stability, medical countermeasures, or other research to ensure product safety or efficacy, our teams of experts are ready for the challenge.
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