According to Fountain Hills resident Ken Gibbs, the road to a proper test kit for something like the coronavirus, now named COVID-19, can be full of twists and turns.

Gibbs helped launch one of the first HIV diagnostic test kits in 1985 and, years later, he was CEO for the U.S. subsidiary for a global clinical laboratory diagnostics kit manufacturer. Recently, state and national leaders have expressed frustration over the fact that test kits for COVID-19 are not yet available for general use, much less a vaccine. Gibbs said it is important for everyone to understand the scientific challenges and processes regarding COVID-19 test kits and why they have not been made immediately ready.

“Developing any diagnostic test kit is much more complicated than baking a nine-tier tower wedding cake, Gibbs said. “No disrespect intended to bakers who have such skills.”

Gibbs explained that COVID-19 was first observed in a cluster of patients in China with pulmonary infections of unknown origin in late December of last year.

“During mid-January, 2020, a novel new coronavirus strain was identified as being associated with the infection,” Gibbs continued. “The U.S. implemented the first phase of preemptive defensive efforts within four weeks from the earliest unspecified widespread infections reports from China.”

Gibbs compared the reaction he’s witnessed from politicians and the media over COVID-19 to similar outcries for HIV diagnostic test kits in the mid-80s.

“Following identification of the virus causing AIDS and 13 months of work by expert research and development scientists at NIH/NCI and leading clinical diagnostics companies, HIV test kits were FDA cleared for testing only the blood supply but initially not for diagnostic purposes,” he continued. “Hindsight revealed the kits were good but not necessarily ready for prime time due to less than optimum sensitivity and specificity. Kit designs improved during subsequent months when widespread performance data became available. Premature release of a diagnostic kit is downright dangerous to the population at large.”

Gibbs said that, among other performance parameters, diagnostic tests must be proven to possess high “sensitivity” (correctly identifying positive specimens as positive) and “specificity” (correctly identifying the COVID-19 from other coronaviruses). As such, a test must be statistically proven to be accurate (positive predictive value and negative predictive value). In other words, it takes time and careful work to do the job well and prevent more widespread issues due to faulty kits.

“The test must be proven to be reproducible when the same sample is tested repeatedly by different technicians,” Gibbs said. “These and other test development parameters must be proven before FDA clears a product for widespread public use. Afterward, manufacturers face an enormous task to scale up, manufacture, package and deliver test kits to laboratories. Subsequently, laboratories must validate kit performance according to specified criteria before they can offer to the public. This process can take days, sometimes weeks.

“A person having a ‘false negative’ test result assumes they have no virus when actually they do have the virus. This individual risks unwittingly infecting others. A person having a ‘false positive’ test result assumes they have the virus when actually they do not have the virus. This individual perhaps unnecessarily self-quarantines, staying home although they have no detectable virus. An individual can have virus that is lower than the limits of detection and consequently test negative but test positive several days later. A test is expected to be valid on the day of the specimen draw only. There is no presumption for this test result for any point following the day of sample collection.”

In other words, shipping test kits before they are ready can go a long way toward making a bad situation even worse, according to Gibbs. His recommendation, as tough as it may be to put into practice at times, is patience.

“I appreciate the urgency for wanting diagnostic tests but this is challenging work and there should be no shortcuts,” Gibbs argued. “Developing a point of care rapid test is more difficult and will take even longer before market availability. The most likely interim therapeutic is likely a repurposed antiviral that is already on the market. A vaccine is a long-term project that cannot be rushed because vaccines provide long-term health protection. Lives depend upon getting this correct.”