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Thursday, December 17, 2020

Here come the non-Rx OTC Covid-19 in-home assays

Good idea? I guess we'll see.

Aussie vendor. First home kit to get an FDA EUA permit. What about QA concerns? I am not yet privy to any data. Stay tuned to this Bat Channel.
Our test is what’s called a fluorescent immunoassay. So we use a quantum dot nanoparticle, which we developed in conjunction with our friends at Thermo Fisher to create an ultra-bright fluorescent reporter to detect proteins of coronavirus. So ours is an antigen test which uses next-generation immunoassay technology to get improved performance on the existing immunoassay products that are in the market.” —Dr. Sean Parsons, Ellume CEO, during a BBC interview.
Like to see some clarification and independent verification on that.

The Authorized Product
Your product is a non-prescription home use test intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens from mid-turbinate nasal swabs that are self-collected by an individual age 16 years or older, or are collected by an adult from an individual 2 years of age and older. This test is intended for use in individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection.

The SARS-CoV-2 nucleocapsid protein antigen is generally detectable in mid-turbinate nasal swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but the clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results in an asymptomatic individual are presumptive and may need to be confirmed with a molecular assay. Positive results do not rule out a bacterial infection or co-infection with other viruses

Negative results are presumptive and confirmation with a molecular assay, if necessary, for patient management may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or management decisions for the individual, including infection control decisions. Negative results should be considered in the context of an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.

Test results from your product will be automatically reported to relevant public health authorities, via your product’s software application (app), in accordance with local, state, and federal requirements, using appropriate LOINC and SNOMED codes, as defined by the “Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests” provided by the Centers for Disease Control and Prevention (CDC).

Your product is a rapid, lateral flow immunoassay that involves the pre-mixing an    d binding of fluorophore specific to SARS-CoV-2 with viral nucleocapsid protein present in a patient specimen. First, the Processing Fluid is added into the Dropper to release the fluorophore. After collecting a mid-turbinate nasal specimen, the Nasal Swab is locked into the Dropper to release the viral antigens from the specimen, which are then bound by the fluorophore. An aliquot of the sample containing the fluorophore-labelled antigen complexes is dispensed into the Analyzer Sample Port. The deposited liquid wicks into the test strip by capillary action. The sample flows across a membrane and traverses a series of discrete capture zones, consisting of immobilized complementary antibodies to SARS-CoV-2 viral nucleoprotein. Fluorescence signals at the two test zones are detected using a single-use optoelectronics reader system, housed within the Analyzer. The tests and controls are interpreted according to thresholds set within the microprocessor contained in the Analyzer. The computed result is communicated to the app and displayed on the user’s smartphone and if selected are also emailed to the user. The total time for the test is 20 min, 5 min for test set up and 15 min once the analyser is activated.

Your product requires the following internal control materials, or other authorized control materials (refer to Condition L), that are processed along with the specimens. All internal controls listed below must generate expected results in order for a test result to be considered valid…    

III. Waiver of Certain Requirements

[FDA is] waiving the following requirements for your product for the duration of this EUA:

Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling, storage, and distribution of your product, but excluding Subpart H (Acceptance Activities, 21 CFR 820.80 and 21 CFR 820.86), Subpart I (Nonconforming Product, 21 CFR 820.90), and Subpart O (Statistical Techniques, 21 CFR 820.250)

(IV)(N). You must have lot release procedures and the lot release procedures, including the study design and statistical power, must ensure that the tests released for distribution have the clinical and analytical performance claimed in the authorized labeling.

(P) You must evaluate the analytical limit of detection and assess traceability7 of your product with any FDA-recommended reference material(s). After submission to and concurrence with the data by FDA, you will update your labeling to reflect the additional testing. Such labeling updates will be made in consultation with, and require concurrence of, DMD/OHT7- OIR/OPEQ/CDRH...
Fairly reassuring, though a number of technical questions remain at this point.

This company started following me on Twitter. Will have to probe further. Click the image above for the link.

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