May 24, 2022

Medical Trend

Medical News and Medical Resources

New COVID-19 test: Results in 3 minutes as easy as a drunk driving test!

New COVID-19 test: Results in 3 minutes as easy as a drunk driving test!



 

New COVID-19 test: Results in 3 minutes as easy as a drunk driving test!

The U.S. Food and Drug Administration ( FDA ) issued an Emergency Use Authorization (EUA) for the first COVID-19 diagnostic test device (InspectIR, PNY-1000) (Figure 1).

The device collects breath samples without the need for a nasopharyngeal swab, and the entire process takes less than three minutes. The size of the device is close to that of an ordinary suitcase, which is convenient to carry and can be used in hospitals, public places and mobile test sites.

 

New COVID-19 test: Results in 3 minutes as easy as a drunk driving test!
Figure 1 FDA authorized EUA for the first COVID-19 breath detection device (Source: FDA official website)

 

John Redmond, co-founder of InspectIR, said: “There is an increasing demand for large-scale centralized COVID-19 testing in the workplace, and third-party COVID-19 nucleic acid testing is too time-consuming and labor-intensive for the workplace. The PNY-1000 is easy to operate and ideal for workplace use.

As long as Put one or two PNY-1000s in the office.

Before going to work, employees will take the test like a “clock”. The results will be available in 3 minutes, which is almost no waste of time.

There is no need to wait for a period of time to get the results like nucleic acid testing, which not only delays time, but also saves time. And it could lead to the spread of the virus.”

 

1. Background of equipment production company

The manufacturer of the device is InspectIR Systems LLC (“InspectIR”), trade name InspectIR COVID-19 Breathalyzer, model PNY-1000. InspectIR was established in 2018 and registered in Dallas, USA, and completed the seed round of financing on November 26, 2019.

InspectIR, in collaboration with the University of North Texas, is committed to developing a portable non-invasive opioid/cannabis/narcotics breath detection tool based on unique patented technology, creating the first truly qualitative and quantitative narcotics portable tester .

Tim Wing, CEO of InspectIR, said: “For decades, the drug testing market has been based entirely on urine and blood analysis, and InspectIR’s products will provide more detailed qualitative and quantitative results that are not only as accurate as urine and blood test results. Comparable and faster detection, with results in seconds.

Our product will bring detection speed that traditional detection lacks, facilitate rapid law enforcement, and thus disrupt the narcotics testing industry.”

 

2. Equipment principle

InspectIR is not limited to the detection of narcotic drugs, the same technical route is also applicable to the detection of new coronavirus. InspectIR developed the PNY-1000 in 2020, and the subsequent testing and compliance process took nearly two years.

With the FDA officially granting its EUA authorization, this detector can be applied to large-scale centralized COVID-19 detection scenarios (Figure 2).

 

New COVID-19 test: Results in 3 minutes as easy as a drunk driving test!Figure 2 Appearance of PNY-1000 equipment (Source: FDA)

 

According to the InspectIR authorization issued by the FDA, the PNY-1000 is essentially a VOC spectrum detector, a qualitative analysis device for the detection of 5 respiratory volatile organic compounds (Volatile Organic Compounds) associated with SARS-CoV-2 infection . Organic Compounds, VOC) metabolites [1] .

PNY-1000 adopts gas chromatography-mass spectrometry technology, which is regarded as the gold standard in the medical and judicial circles, and can quickly and accurately detect the content of the above five organic compounds from the breath of the tested object, as the criterion for determining whether the COVID-19 is infected. (image 3).

 

New COVID-19 test: Results in 3 minutes as easy as a drunk driving test!Figure 3 Schematic diagram of GC-MS (Source: Wikipedia)

 

In March 2022, eClinical Medicine , a sub-journal of The Lancet , published a research result entitled ” Detection of SARS-CoV-2 infection by exhaled breath spectral analysis: Introducing a ready-to-use point-of-care mass screening method ” ( Figure 4) [2].

In this study, it was found that aldehydes, ketones, and alcohol gases were contained in the breath of people infected with the COVID-19, and these gases did not appear in the breath of patients with other mainstream diseases (even including typical pneumonia), which is specific to the COVID-19 .

This also provides a scientific basis for the development of PNY-1000. PNY-1000 can detect 5 organic compounds known to be strongly associated with new coronavirus infection: acetaldehyde, octanal, acetone, butanone and methanol .

New COVID-19 test: Results in 3 minutes as easy as a drunk driving test!

Figure 4 Research results (Source: eClinical Medicine )

 

 

3. Equipment test results

According to the PNY-1000 test document released by the FDA, the test process of PNY-1000 is: subjects should not eat, drink or use any tobacco products within 15 minutes before the test.

First, the vacuum pump evacuation system evacuated the collected 0.25L breath sample provided by the subject within 10 seconds.

Subsequently, the breath sample interacts with a preconcentrator in the system to collect and concentrate the sample, and is detected by a downstream residual gas analyzer for specific VOCs.

Finally, by running the algorithm to determine the VOC and proportion present in the sample, output the SARS-CoV-2 test result: positive (+), negative (-).

Test results will be displayed on the instrument screen in less than 3 minutes. All positive test results must be subsequently confirmed by a highly sensitive SARS-CoV-2 test [3].

A sample of 2,409 subjects was tested, and it was found that the accuracy rate of positive tests was 91.2%, and the accuracy rate of negative tests was as high as 99.3%. Test samples include Delta, Omicron and other variants.

This set of data proves that for subjects who are not infected with the new coronavirus, the accuracy of the PNY-1000 test is very high, and the possibility of “false positives” is very low; for positive infections, the accuracy of this test method is very high. , and also met the general requirements for rapid testing methods by public health agencies in many countries, including the United States.

Conventional antibody detection methods have been unable to effectively avoid the impact of antigen cross-reaction on the test results, and subjects infected with other epidemics (such as influenza caused by coronavirus) may lead to false positives in the COVID-19 test; and because of the aforementioned volatility Organic matter is only associated with new coronavirus infection, so antigenic cross-reaction can be avoided. As a rapid detection method, the detection accuracy of PNY-1000 for negative subjects is as high as 99.3%, and the probability of false positives is very low.

Although PNY-1000 performed well, the FDA also made it clear that this insufflation detection method still cannot replace the status of nucleic acid detection, and positive results should be additionally carried out by nucleic acid detection for final confirmation .

 

 

 

4. Equipment price and time to market

On April 22, John Redmond said, ” Currently each machine can only process about 20 samples per hour, so a lot of equipment is required for large-scale screening . It may take 10 to 12 weeks for the first equipment to be on the market. The cost is about $10 to $12. “

The FDA said the company said it planned to produce about 100 devices per week, but it was unclear when that level would be reached.

Some COVID-19 breath tests have already been tested in pilot programs or licensed for use in other countries, but the InspectIR Breathalyzer will be the first to be available in the U.S.

 

 


How do experts and scholars evaluate PNY-1000?

Nathaniel Hafer , a molecular biologist at the Massachusetts Institute of Technology School of Medicine, said: “The PNY-1000 is very fast and accurate in detecting COVID-19s, which is impressive. Based on this technology, it is very valuable to expand the types of viruses that can be detected.”

“I think this is a very exciting development for the whole field of breath analysis, and it’s a big step forward,” said Cristina Davis , UC Davis vice chancellor who has been developing coronavirus detection technology. step.”

“We have been considering this type of testing throughout the pandemic and have been waiting for products and technologies to be licensed, but only in the How useful PNY-1000 is will really be determined in practice. PNY-1000 doesn’t give you a definitive diagnosis, it gives you a biochemical pattern associated with the disease.”

“I would still like to see more independent data on the performance of the PNY-1000 device, as well as more details on the compounds it detects,” said Susan Butler-Wu , a clinical microbiologist at the Keck School of Medicine of USC . Infection diagnosis is not well developed, and without more realistic data, I feel it is too early to use it to diagnose patients.”

 

 

New COVID-19 test: Results in 3 minutes as easy as a drunk driving test!

(source:internet, reference only)


Disclaimer of medicaltrend.org