Rapid and Quantitative Tests

For an individual, a 7-day temporal gap that is “taken out of the equation as if it is non-existent” is not only irresponsible but also dangerous. It gives a perceived “all-clear” to an individual who may have been exposed and who might have contracted the virus in the last 7-days prior to the test. In a hypothetical societal setting of 100,000 people being tested at the same time using the same “7-day temporal gap” device, this translates to 100,000 people “not cleared to resume life” because their last 7 days were “unaccounted for from a testing standpoint.” That’s a lot of uncertainty considering a Pandemic can originate from just one infected person. A declaration of negative results for an individual that contracted the virus within the last seven days when antibodies are undetectable almost gives the certainty that the tested individual will not self-isolate and take other precautions such as distancing from family members – running the risk of spreading the virus than when a more accurate diagnosis was performed.

Re-testing is one way to mitigate the risk associated with device sensitivity. Retesting can close the gap if taken 7 days after the first test was taken to account for the “missing days.”

Another way to address this issue is to use devices that are sensitive enough to shorten the 7 day period. Quantum Dot technology amplifies signals from specimens 100 times that a 48-hour detection is possible. Shortening the gap from 7 days to 48 hours is a significant upgrade on a personal level and an astronomical improvement on a societal setting.
Mathematically, people should at least have a series of 2 tests. The first one is to test for exposure within the sensitivity range of the testing device and the second one to account for the shortcomings of the sensitivity range.</>

More information always translate to better decision-makings. Quantitative IgM and IgG can provide doctors and scientists additional tools to better manage both the infected and the uninfected population. A “simple positive” may mean that traces of bio-markers are present in specimens but isn’t conclusive of whether someone is “sick and contagious” or “was sick but is now cured and not contagious (anymore)”. Technologies that can generate quantitative data already exists. The importance of Quantitative Data during the immunization stage of the pandemic.

In a paper written by Hongyan Hou, Ting Wang, Bo Zhang, Ying Luo, Lie Mao, Feng Wang, Shiji Wu & Ziyong Sun titled, “Detection of IgM and IgG antibodies in patients with coronavirus disease 2019”, the authors indicated, “Therefore, we speculate that the quantitative results of antibody detection are associated with the severity of COVID-19 and have potential value for use in predicting the disease prognosis.”…meaning, they are speculating that actual quantities of IgM and IgG antibodies and possibly their ratios may determine other factors than merely just positive or negative diagnosis. Noteworthy also is their observation, “The positive rates of IgM and/or IgG detection were not significantly different among the mild, severe and critical groups. However, quantitative analyses of antibody levels over the disease course revealed that SARS-CoV-2-specific IgM levels were higher and neutralising IgG levels were lower in patients in the critical group, as compared with the other groups, which might be because of high disease activity and/or a compromised immune response in these patients. In contrast, in the mild group patients, IgG was maintained at a high level, while IgM levels gradually decreased when most of the patients were in the recovery state of infection. Furthermore, the level of IgM antibody was higher in the group of deceased cases than that in the group of recovered cases, whereas the IgG level was not significantly different between these groups. The IgM level showed heterogeneity within the group of deceased cases, and some patients had very high IgM levels which might be in the active status of disease or very low IgM levels due to the long disease course . The increased IgM level in the deceased case group might be related to the higher disease severity in these patients and indicate a poor prognosis. Alternately, cytokine storm, severe immune dysfunction and other commobidities might be the important risk factors in these cases.” 5,18,21,24

NanoHarmonics is deploying a quantitative IgM IgG diagnostic device based on Quantum Dot technology through strategic alliances with the goal of proving that quantitative solutions will be able to accelerate solutions to the pandemic in ways that qualitative testing devices can’t. Currently, we are working with a group of medical doctors to map out issues inclusive of but not limited to: (a) creating a working model for the deployment of diagnostic devices to medical clinics by defining all the essential components of the supply chain from patient registration, integration with the doctor’s EMR system, reporting and billing (for both the insured and the uninsured); (b) completing quantitative clinical trials for regulatory compliance; (c’) creating a working model that will be applicable to monitored organizations particularly to mitigate risk and/or infection therein during pandemics; (d) integration with technologies that shall assist in infection monitoring and contact tracing in the event that an infection is ascertained; (e) exploration of potential alliances with organizations who shall be responsible for the immunization process to determine ways and means to utilize quantitative screening to make immunization more effective, etc.

(5) Chen N, Zhou M, Dong X et al. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet 2020; 395: 507–513. 
(18) Wang D, Hu B, Hu C et al. Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus-infected pneumonia in Wuhan, China. JAMA 2020; 323: 1061. (21) Xu Z, Shi L, Wang Y et al. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med 2020; 8: 420–422. (24) Zumla A, Hui DS, Azhar EI, Memish ZA, Maeurer M. Reducing mortality from 2019-nCoV: host-directed therapies should be an option. Lancet 2020; 395: e35–e36.