Saturday, April 4, 2020

How ABBOTT'S Five Minute COVID-19 Test Device Works?

We have seen it all over the news! President Trump has showcased it in one of his press conferences. And we expect that it will be a game-changer in the fight over COVID-19 pandemic. As one of the best strategies to fight COVID-19 is massive testing of the public. A lesson we learned from various countries like South Korea, Germany, and Singapore.

ID NOW ABBOTT
Abbott ID NOW Testing Device

Why it is important?


With the spread of the COVID-19 pandemic, there is a great need for testing millions of people. As testing people will enable health providers to actively act based on the results. With around 80% of COVID-19 patients showing no or mild symptoms. Thus testing plays a major role in having COVID-19 positive patients to be quarantined until they are no longer carriers of the virus.

How ID NOW Works? 


First things first, the device name is ID NOW™  Formerly Alere™. That is a fast molecular testing device produced by Abbot Laboratories. It will give positive results in as little as 5 minutes. however, negative results will need as much as 13 minutes to show up.

The Test Kit has a chemical that rips open the virus allowing the genetic material of the COVID-19 to be read by the ID NOW device. Even f there is a small quantity of the virus ID NOW will replicate the virus's genetic material to be detected. So mainly the ID NOW will read the RNA of the virus, not the antibodies produced by the patient's immune system. So it is similar to PCR tests in this manner.

Now here is the good part, the ID NOW device is not only used to test for COVID-19. Actually, it was produced before the pandemic to test patients for Influenza A & B, Strep A, and respiratory syncytial virus (RSV) testing.

For those who already have the device already they will need to buy an additional 40$ additional cartridge. This cartridge is specifically designed to test patients for the SARS-COV-2 virus. It also means that the ID NOW device will not become obsolete after the pandemic is over as test centers can make use of it's testing capabilities for Flu, strep, and RSV in addition to COVID-19 testing. Also, this means that the already existing 18,000 devices that are spread around the USA health center, hospitals and clinics.

Before we start with the known compromise between quality and quantity let us go a little deeper into how does the ID NOW works in comparison with conventional testing devices. Conventional devices will replicate the virus's RNA by repeatedly cycling temperature from normal to medium then to high and back down to normal. Where the ID NOW is able to replicate COVID-19 RNA in normal temperature conditions. Thus allowing it to provide the results in a 5-15 minutes span.



Where is it best to use? 


The ID NOW cutting advantage is its small size that is just a few pounds. Allowing the ID NOW to be fitted in small clinics and even in doctors' offices.  That, in turn, will allow healthcare personnel to better deal with patients as they are able to get the results in a few moments.

Since the ID NOW is a lightweight small device it is considered a portable device, where it can be used seemingly anywhere it is needed. For large hospitals with the ability to accommodate large testing machines, Abbott’s m2000 RealTime system got U.S. Food and Drug Administration approval for use in hospitals and molecular laboratories to diagnose the infection. That system can churn through more tests on a daily basis, up to 1 million a week, but it takes longer to get the results.

5 - 15 Minutes what does that mean?


Well, put simply, if a patient has high COVID-19 concentration in the samples taken from the nose or the back of the throat. Then the device can detect that the patient is COVID-19 positive in 5 minutes. However, if the concentration of the virus is less, then the results can take up to 15 minutes to verify.

Test Accuracy VS Speed


What makes it able to do the test so fast compared to conventional testing equipment?


It is one thing to have a fast testing device, but it is another thing to have accurate results. Usually the faster the test the lower the accuracy is. We will need to know how accurate this device is in comparison to its speed. As at the end of the day, we need reliable data that can have health care providers know coronavirus infected people to be separated from the non-infected ones. 

Are we Sacrificing Quality for the sake of Speed? 


There are no specific numbers stating the accuracy of the ID NOW testing device. Although, we are inclined to observe for the few coming days to get feedback from users of the ID NOW with regards to test accuracy and margins of error. However, we have the below image, provided on the Abbott website, comparing the speed of ID NOW with normal PCR tests. So we feel that it is only fair that the ID NOW is as accurate as normal PCR tests.


Competitors have Faster Devices!


Well, we heard and saw devices that can give test results in as low as 2 minutes. So isn't it more logical to have these devices to be used for testing? 

It is a fact that there are some devices that claim to give faster test results. However, those devices are not looking for COVID-19 RNA, but it looks for antigens that are produced by the immune system of the infected patient. Usually, such tests are not accurate as many early-stage patients may not have antigens in their bodies fighting the virus to be detected by the testing device. Besides, these devices need blood samples to be withdrawn from the patient, meaning a greater chance of cross-contamination. 

Test Accuracy


So far there have been no numbers on the accuracy that are concise enough for us to be able to Juge. "Highly accurate" and more than 90% accurate is not enough. Having false positive or false negatives with a 10% margin of error is not acceptable. But it seems that many tests performed have the same margin of error problem.

That is usually attributed to how early is the patient tested. In other words, a patient that is infected today is likely to test negative if she was tested for the virus. But after a few days, the same patient will test positive. 

Production Quantities 


It is not clear how many of these devices there will be and when are they going to be available. Many reports vary from as little as 5500 devices to as much as 500,000 devices. We will need an official report to be released from Abbot laboratories related to production capacity.

Though Abbott laboratories announce that they will be producing around 5 million tests in April. But these tests are combines for normal testing and fast testing.

What was already announced from Abbot Laboratories' official website is that they are pledging to provide 50,000 tests/day. But without mention of the number of devices. Also according to Abbots's official website:

"This comes on the heels of our announcement last week of the availability of the Abbott RealTime SARS-CoV-2 EUA test under FDA EUA, which runs on m2000 RealTime molecular system for centralized lab environments. Combined with ID NOW, Abbott expects to produce about 5 million tests in April."

Consumables


Each Assay kit contains all necessary components for testing to include: 24 tests, swabs for sample collection, pipettes, positive and negative controls.

Price Tag


There are no clear pricing criteria for the ID NOW testing device. We are looking forward to having some of the devices to be distributed for free to some of the most affected areas, Just like Tesla motors did when producing the Medtronic Ventilators PB980.

Our expectations are that the ID NOW price might range between 10,000-20,000 USD. But we don't have any confirmed price of these small devices.

Technical Specs


  • Color Touch Screen 3.5”
  • Communications 10/100 Mbps Ethernet Port for Data Transfer
  • 3 x USB Ports for data export,
  • barcode reader and printer 
  • Data storage 999 patient test results 
  • 99 QC test results 
  • Memory allows search and retrieval Archive or export via USB
  • Power Supply 12V DC from external AC/DC 
  • supplied plug pack DC Voltage fluctuation: ±10% DC Current consumption: 12V DC, 3.0 Amps
  • Dimensions 8.15” W x 5.71” H x 7.64” D 207 mm W x 145 mm H x 194 mm D 
  • Weight 3.0 kg (6.7 pounds)
  • Operating Environment Indoor Use 15ºC to 30ºC (50ºF to 86ºF) 
  • Humidity 10% to 80% RH (non-condensing) 0m (1.01 bar) to 2000m (0.763 bar) IP20
  • Storage 15ºC to 30ºC (50ºF to 86ºF) 10% to 80% RH (non-condensing) 0m (1.01 bar) to 2000m (0.763 bar)
  • ID NOW Instrument User Manual 1.3.2 
  • 12V Power Supply 
  • Rated input voltage: 100-240VAC 
  • Rated input frequency: 50/60Hz 
  • Rated input current: 1.2 Amps 
  •  As per instrument Output voltage: 12V Output current: 3.5 Amps


ID NOW Training


It is very useful not only to have the ID NOW device to be available widely across the USA and even across the Globe. Training healthcare personnel on how to use the ID NOW plays a crucial part in fighting the COVID-19 pandemic. 

Thanks to Abbott they have provided video material of various aspects to dealing with device usage. Divided into eight training modules. Where each module explains a specific part of using the ID NOW. We have the videos, most of them are from 3-10 minutes and have valuable information on best user practices. The longest of all modules is the first one as it is almost 15 minutes long and teaches the user how to unpack and prepare the ID NOW.  

The first 4 modules are the most important ones in addition to the 8th module. As they contain the core material needed to effectively operate and use the ID NOW testing device.  

  

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