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From todays broker note:
.."In order for it to prospectively capture a good slice of the multi-billion US$
opportunity for sales of rapid SARS-CoV-2 antigen tests to governments, agencies,
healthcare providers, international retailers etc., Avacta understands that it is now
ultimately only limited by manufacturing capacity and so has further expanded its
production relationships with Abingdon Health."

.."ultimately only limited by manufacturing capacity".
So not limited by approvals then.

Hi Milcait,

At the bottom of your link is a box containing '5 references'.

The fourth reference provides the link "SalivaDirect: Simple and sensitive molecular diagnostic test for SARS-CoV-2 surveillance"

https://www.medrxiv.org/content/10.1101/2020.08.03.20167791v1

"Current bottlenecks for improving accessibility and scalability of SARS-CoV-2 testing include diagnostic assay costs, complexity, and supply chain shortages. To resolve these issues, we developed SalivaDirect. The critical component of our approach is to use saliva instead of respiratory swabs, which enables non-invasive frequent sampling and reduces the need for trained healthcare professionals during collection. Furthermore, we simplified our diagnostic test by (1) not requiring nucleic acid preservatives at sample collection, (2) replacing nucleic acid extraction with a simple proteinase K and heat treatment step, and (3) testing specimens with a dualplex quantitative reverse transcription PCR (RT-qPCR) assay. We validated SalivaDirect with reagents and instruments from multiple vendors to minimize the risk for supply chain issues. Regardless of our tested combination of reagents and instruments from different vendors, we found that SalivaDirect is highly sensitive with a limit of detection of 6-12 SARS-CoV-2 copies/µL."

The next link is provided in the text... https://covidtrackerct.com/about-salivadirect/

"SalivaDirect was issued an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) on August 15, 2020. It is the first EUA issued by the FDA for a protocol. Thus, there is not a SalivaDirect kit to buy, only a protocol that we can provide for free to conduct cheap saliva testing."

"SalivaDirect is a new method for testing people suspected of SARS-CoV-2 infection. While it still relies on a similar molecular process as earlier tests (called RT-qPCR), we made it simpler to drive down costs and place less stress on the supply chains."

++++

Seems to me this might be of interest to some of the poorer countries.

They would still require a PCR instrument and trained staff, but running costs might be lower.

BinaxNOWTM COVID-19 Ag CARD
Source: Instructions for Use
Rx only (so not OTC)

INTENDED USE
The BinaxNOWTM COVID-19 Ag Card is a lateral flow immunoassay intended for the qualitative
detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasal swabs from
individuals suspected of COVID-19 by their healthcare provider within the first seven days of
symptom onset. Testing is limited to laboratories certified under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to
perform moderate, high or waived complexity tests. This test is authorized for use at the Point of
Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate
of Compliance, or Certificate of Accreditation.
The BinaxNOWTM COVID-19 Ag Card does not differentiate between SARS-CoV and SARS-CoV2.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is
generally detectable in nasal swabs during the acute phase of infection. Positive results indicate
the presence of viral antigens, but clinical correlation with patient history and other diagnostic
information is necessary to determine infection status. Positive results do not rule out bacterial
infection or co-infection with other viruses. The agent detected may not be the definite cause of
disease. Laboratories within the United States and its territories are required to report all positive
results to the appropriate public health authorities.
Negative results from patients with symptom onset beyond seven days, should be treated as
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 patient management decisions, including infection control
decisions. Negative results should be considered in the context of a patient’s recent exposures,
history and the presence of clinical signs and symptoms consistent with COVID-19.
The BinaxNOWTM COVID-19 Ag Card is intended for use by medical professionals or trained
operators who are proficient in performing rapid lateral flow tests.
++++
If the FDA can approve this, we will have no trouble with the spit stick.

BinaxNOWTM COVID-19 Ag CARD
Instructions for Use
Rx only (so not OTC)

INTENDED USE
The BinaxNOWTM COVID-19 Ag Card is a lateral flow immunoassay intended for the qualitative
detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasal swabs from
individuals suspected of COVID-19 by their healthcare provider within the first seven days of
symptom onset. Testing is limited to laboratories certified under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to
perform moderate, high or waived complexity tests. This test is authorized for use at the Point of
Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate
of Compliance, or Certificate of Accreditation.
The BinaxNOWTM COVID-19 Ag Card does not differentiate between SARS-CoV and SARS-CoV2.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is
generally detectable in nasal swabs during the acute phase of infection. Positive results indicate
the presence of viral antigens, but clinical correlation with patient history and other diagnostic
information is necessary to determine infection status. Positive results do not rule out bacterial
infection or co-infection with other viruses. The agent detected may not be the definite cause of
disease. Laboratories within the United States and its territories are required to report all positive
results to the appropriate public health authorities.
Negative results from patients with symptom onset beyond seven days, should be treated as
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 patient management decisions, including infection control
decisions. Negative results should be considered in the context of a patient’s recent exposures,
history and the presence of clinical signs and symptoms consistent with COVID-19.
The BinaxNOWTM COVID-19 Ag Card is intended for use by medical professionals or trained
operators who are proficient in performing rapid lateral flow tests. BinaxNOWTM COVID-19 Ag
Card is only for use under the Food and Drug Administration’s Emergency Use Authorization.
++++
This isn't the get out of jail free card America is waiting for.

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