WHAT YOU NEED TO KNOW:
- Coronavirus test kits from Abbott, according to a recent analysis, failed to detect traces of the virus of at least 48%.
- Abbott clarified that the device has minimal false-negative rating results as presented to the FDA.
- In a clinical setting, the analysis of Abbott’s ID NOW system is found to be “unacceptable” though it has not been peer-reviewed.
According to a study about to be published by New York University (NYU), the rapid tests supplied by Abbott could miss almost half of COVID-19 strains.
A review of Abbott’s ID NOW system showed that the results are considered not acceptable under medical standards. To date, the kit has not yet undergone peer-review and has not been approved for a medical journal.
A spokeswoman for Abbott said that it was unclear whether the researchers handled the samples properly or not, noting that the company’s false-negative rate it submitted with the Food and Drug Administration (FDA) has only a result of .02 percent.
In a statement published by The Hill, Abbott spokesperson, Darcy Ross, said based on their coordination with test kit users, the device is working as intended.
She added: “ID NOW is an important tool that delivers information where it’s needed most — taking the fight to the frontlines so that public health officials and healthcare providers can make critical decisions.”
The researchers explained the NYU labs tested kits that had results come out too late, and they were looking for methods that can provide COVID-19 diagnosis quicker.
According to Abbott, the ID NOW test can give positive results from 5 to 13 minutes and 13 minutes for negative.
The test kit also has its built-in point of care test feature, and it means that the samples don’t have to be necessarily sent to the main lab.
The White House utilizes the kit on administration officials, and other individuals who might interact with President Donald Trump. The president recommended the kit’s use after it was authorized in March by the FDA for emergency use.
Trump also recommended some of the testing machines to the Capitol for lawmakers’ use.
According to the study, Abbott’s test seemed to neglect one-third of samples gathered with nasopharyngeal swabs from the back of the nose, which turned out to be tested positive from rival Cepheid’s result.
The analysis further said that if using samples with dry nasal swabs as per the company’s recommendation, Abbott’s kit missed over 48 percent of the infection.
The accuracy of the ID NOW system has been questioned before, and the study echoed a similar concern. Other groups of researchers in April concluded that the test had a false negatives rating of high, making Abbott advise labs to not keep samples in “viral transport media” before testing to prevent sample dilution.
The researchers further noted on their analysis that due to the urgency to expand coronavirus testing capacity, the FDA gave some leeway on its examination procedures.
Source: The Hill