Sample Submission Protocol: Fill & Download for Free

There was this place that said it was collecting blood for science and would pay you. The thing is that they were paying three times the average amount, AND that they expected people to travel there for a interview and again, not follow standard protocols of paying for your time and sample submission for testing. Very creepy.

Assume US market and process as it is the largest Medical Device market share in the world currently.FDA classification of the Device.I, II,IIImplantable, Surgical, Monitor, Diagnostic...PMA or 510KStatistical power to validate hypothesis.Your Feasibility data should indicate the sample size you need.Multi-site or single siteMy experience is diagnostic medical imaging equipment. For the last start-up I worked at, we did a 510K with Mayo clinic via a Federal Grant. I think the study size was something like 2500 patients approximately. This device was class I and we were looking to be an option for women with dense breasts as a screening device. I think this worked out to be around $5-6 million dollars.Device CostService CostFacility Cost: Room renting and accommodation for your specific equipmentDrug/Radiotracer/consumable CostPatient Reimbursement: This can be a huge number depending on how invasive it is or if it is a drug.Lawyers FeesCRO/CRA Fees: Very pricey for Multicenter studyRegulatory Consulting FeesBiostatistical writeup and Protocol DevelopmentIRB approval feesIndependent reviewers/readersTraining of all members and contractorsFDA Submission FeesMedical WriterFeasibility Study Protocol and AnalysisMy current company is doing a PMA, I can't disclose numbers, but it is vastly more expensive and much more time consuming. Also non-invasive breast imaging.

There is a protocol that can be done to have a cat tested if Covid19 is suspected. It involves the state veterinarian, the state public health office, etc. Here is the protocol veterinarians are following:1 | P a g e Thursday, April 16, 2020 Veterinary FAQs on Testing Companion Animals for SARS-CoV-2 in North Carolina About SARS-CoV-2 SARS-Cov-2 is a novel coronavirus that causes coronavirus disease 2019 (COVID-19), a respiratory illness that can spread from person to person. Human patients with COVID-19 have experienced mild to severe respiratory illness, including fever, cough and shortness of breath. While much is currently unknown about this organism, no evidence suggests that pets can spread COVID-19 to humans. The Centers for Disease Control (CDC), United States Department of Agriculture (USDA), and American Veterinary Medical Association (AVMA) DO NOT currently recommend routine testing for COVID-19 be performed for domestic animals at this time. How do I order testing for SARS-CoV-2? As there is currently no scientific basis to support widespread testing of animals, SARS-CoV-2 testing is only available by special request and will be approved only on a case-by-case basis. Test requests must be submitted by an USDA accredited veterinarian who is responsible for the animal’s care. The animal(s) should have already been tested and found negative for routine diseases that may cause the observed clinical signs. Veterinarians wishing to request SARS-CoV-2 testing should send the request along with the medical history/record including all previous disease screening results to [email protected]. Who will decide if a test request is approved? The decision on whether to approve testing will be made collaboratively between North Carolina’s State Veterinarian and State Public Health Veterinarian. Animal testing for SARS-CoV-2 will only be approved if both officials agree it is necessary to protect the health of vulnerable human or animal populations. The criteria for approval of animal testing can be found on the following page. Why do I have to get approval to test my patients for SARS-CoV-2? Testing animals for SARS-CoV-2 is not generally recommended and will be approved only under limited circumstances, for the following reasons: • The COVID-19 pandemic is being spread by person-to-person transmission. While limited evidence indicates that domestic animals can be infected, currently no evidence shows that domestic animals can spread SARS-CoV-2 to humans. A positive test in a domestic animal therefore has limited public health significance. • Widespread testing of domestic animals for SARS-CoV-2 would deplete personal protective equipment (PPE) and testing supplies that should be conserved for human healthcare providers to respond to the pandemic. • Since no specific treatment exists for SARS-CoV-2 in animals, testing an animal would generally not change its treatment. Where will the testing be completed? Testing for suspected SARS-CoV-2 will be treated as a novel disease in companion animal and, therefore, requires use of a National Animal Health Network (NAHLN) laboratory approved by the North Carolina State Veterinarian. Any positive samples reported from the testing laboratory will be confirmed through additional testing by USDA’s National Veterinary Services Laboratory (NVSL). Who will pay for SARS-CoV-2 testing? If animal testing is approved, the animal’s owner will incur the financial costs associated with specimen collection, shipping, and testing. Who will collect the animal samples? The attending accredited veterinarian who examines the pet will collect the animal samples. A practitioner who believes testing is warranted should first contact [email protected] for testing approval and guidance on sample submission. Because of the nature of the SARS-CoV-2, animal and public health officials want to avoid the potential exposure of additional individuals in the collection of samples. 2 | P a g e Thursday, April 16, 2020 My client has been diagnosed with a confirmed case of COVID-19. What should I tell him/her to do if the pet does not qualify for testing? Although no pets have been reported sick with COVID-19 in the United States, the current recommendation is: • People sick with COVID-19 limit contact with animals until more information is known about the virus. • When possible, another member of the household should care for the pet. • If possible, the infected person should avoid contact with the pet, including petting, snuggling, being kissed or licked, and sharing food. • If an infected person must care for the pet while sick, he/she should wash their hands before and after interacting with animals. Is there any other testing available for SARS-CoV-2 in pets? There is no other testing for SARS-CoV-2 in pets available in North Carolina at the writing of the document. Should different testing become available, this document will be updated. 3 | P a g e Thursday, April 16, 2020 Criteria and Sample Processing for Companion Animal Testing for SARS-CoV-2 in North Carolina Criteria for Companion Animal Testing for SARS-CoV-2 in North Carolina Companion animals in group residential settings for high-risk people o Clinical signs potentially compatible with coronavirus infection, and o No evidence for alternate diagnosis after a thorough species-appropriate diagnostic workup, and o Animal lives in a group residential setting with a human population at high risk for severe complications from COVID-19 (e.g., a nursing home). Companion animals housed in animal shelters o Atypical pattern of disease suggesting a novel pathogen arises in a mass care situation, such as an animal shelter and common causes of illness have been ruled out by a thorough, species-appropriate diagnostic testing with results provided with the application; and o Clinical signs potentially compatible with coronavirus infection. Sample Processing for Companion Animal Testing for SARS-CoV-2 Required Information to Request Approval o The USDA accredited veterinarian shall request approval prior to sending the samples. Any samples received without prior approval will not be sent for testing. o The USDA accredited veterinarian shall provide the following information: ➢ Animal owner’s name, address, email address, and phone number; ➢ Animal’s name, species, age, sex; ➢ Animal’s location if different from the owner’s address; ➢ Veterinarian’s reason for testing the animal(s); ➢ Findings of physical, radiographic, or sonographic examinations and any relevant lab results; and ➢ Complete patient history. Who will collect the animal samples? The attending accredited veterinarian who examines the pet will collect the animal samples. The veterinarian should collect the sample using appropriate personal protective equipment and sample collection methods. Because of the nature of the SARS-CoV-2, animal and public health officials want to avoid the potential exposure of additional individuals in the collection of samples. What sample types will be collected? Oral, nasal and rectal/fecal swabs should be collected per OIE (World Organization for Animal Health) recommendations and according to established sample collection protocols. Please submit oral, nasal and rectal swabs in separate vials. How should samples be stored? Samples should be stored in viral transport media (e.g., Universal VTM or BHI); dry swabs are not acceptable for testing. Samples may be stored at 2-8°C for up to 72 hours after collection. How should samples be packaged and labelled? Please follow the North Carolina Veterinary Diagnostic Laboratory System (NCVDL) protocols for packaging and labeling submissions. Samples should be shipped using gel ice packs. How should samples be submitted to NVSL? NVSL is not accepting diagnostic samples for testing. If the initial testing shows a positive result, the samples will be sent by the testing laboratory to NVSL for confirmation testing. What is the reporting process? The NCVDLS will receive the results and forward them to the submitting veterinarian.