RINO-PHARYNGAL MOLECULAR SWAB FOR THE RESEARCH OF SARS-COV-2 RNA INFORMATION AND INFORMED CONSENT Dear Madam / Sir, the molecular test to which he voluntarily chose to undergo has the objective of identifying with a molecular technique (from a nasopharyngeal swab) the presence of RNA of the SARS-CoV-2 virus, responsible for the COVID-19 disease (acronym of Co (corona) , Vi (virus), D (disease, which in English means disease) and 19 (the year of identification of the virus). Coronaviruses are a large family of viruses known to cause illnesses ranging from the common cold to more serious illnesses such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). Coronaviruses were identified in the mid-1960s and are known to infect humans and some animals. To date, seven coronaviruses are known to cause disease in humans. They have a rounded morphology and dimensions of 100-150 nm in diameter, their name derives from the fact that under the transmission electron microscope, the virions appear spherical with a “crown” shape. This particular aspect is due to the presence of the spike protein (from the English tip, spike) represented by the glycoprotein (S), formed by two functional subunits (S1 and S2) which, together, form a crown surrounding the virion. It is the S glycoprotein that determines the specificity of the virus for the epithelial cells of the respiratory tract. Additional structural proteins include: the envelope (E), the matrix protein (M) and the nucleocapsid (N). The Coronavirus genome consists of a single large-sized RNA strand; no larger RNA viruses are known. The mode of transmission of SARS-CoV-2, in the light of current knowledge, is by droplets and by contact with the patient's respiratory secretions, contaminated surfaces and equipment. The incubation period seems to vary from 1 to 14 days, that of manifestation of the disease from 3 to 7 days after exposure, but several studies have shown that it can also occur asymptomatically. In symptomatic patients, the most common signs are fever and cough, but it can also present with symptoms such as dyspnoea, muscle aches, sore throat, headache, diarrhea, conjunctivitis, loss of taste or smell. In more complex cases, pneumonia can develop into a condition that requires hospitalization, in the most serious and urgent cases, in intensive care. The people most susceptible to severe forms are the elderly and those with chronic conditions such as diabetes and heart disease. The nasopharyngeal molecular swab is a rapid examination, which can be performed in a few seconds by healthcare personnel, which allows to detect the possible presence of the SARS-Cov-2 virus, the causative agent of COVID-19; the analysis is carried out by amplification of viral nucleic acids with the Real-Time RT-PCR (Reverse Transcription-Polymerase Chain Reaction) method. The test shows if the subject has a Sars-CoV-2 infection, "photographing" the condition at the time of collection; it should be borne in mind that the presence of the virus is not detectable in case of low viral load or if the swab is carried out in the extremely initial phase of contagion. The maneuver to obtain a nasopharyngeal respiratory secretion sample can cause discomfort and rarely bleeding. The tampon is still painless, although for some people it may be annoying, and is carried out by inserting a stick, flocked at the end, into one of the two nostrils until it reaches the posterior wall of the nasopharynx (upper part of the pharynx). The sample taken will be analyzed by the highly specialized laboratory of medical genetics and molecular biology of the Artemisia Lab Network "Laboratory of Clinical Analysis Alessandria Srl", located in Rome, Via Velletri, 10, a health center authorized by the virology laboratory of IRCCS Spallanzani, part of the Coronet network. The result will be sent by email within 24 hours of arrival at the laboratory. This term, however, may vary due to needs related to repetition of the exam, suboptimal results, diagnostic investigations or interpretative doubts. MOD-PCR COV REV1 04.07.2021 PAG. 1 OF 4 The result may be: • not detected / negative: ongoing Sars-Cov-2 (COVID-19) infection is excluded • detected / positive: the ongoing infection with Sars-Cov-2 (COVID-19) is confirmed • indeterminate / invalid: the sample collected may be insufficient and / or unsuitable for the examination Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions, and are also exclusively related to the search for the virus at the time of swab execution. The Clinical Analysis Laboratory Alessandria srl, where the test in question is performed, is authorized for this particular diagnostic activity by the Lazio Region and guarantees the execution of the tests in full compliance with quality standards; however it is necessary to notify that the test has some reliability limits due to its intrinsic characteristics. In particular, according to the data of the scientific literature, we inform you that the search for RNA of the SARS-CoV-2 virus in samples taken by nasopharyngeal swab can give, in some cases, even a false-negative result as well as a result false positive. The molecular analysis on a swab is performed with the aid of CE-IVD kits with a sensitivity and specificity higher than 95%. Despite the high specificity, the analysis is not infallible and there may be cases of false negatives (due to the unsuitability of the sample, to a very low viral load or to spontaneous mutations in the target sequence) and it is therefore recommended that the test be repeated a second time. once, or sometimes even several times, in the presence of symptomatology indicative of COVID-19 and despite an initial negative response to the investigation. Molecular diagnostic tests for SARS-CoV-2 infection are performed at no charge to the SRG. Molecular tests and related reports, complete with personal data (sensitive personal data) will be recorded and sent to the Lazio regional IT platform, COVID body, and will be used for public health purposes. If the test is positive, the personal data and the result will be sent electronically to the SISP (Hygiene and Public Health Service) of the competent ASL, as well as to the regional notification body SERESMI with a special form prepared by the Lazio Region ( Annex 3 of the Order of the President of the Lazio Region of 17/03/2020, n.Z00009). It is reiterated that in case of positivity you must contact your general practitioner and / or pediatrician of free choice informing him of the positivity to the SARS-CoV-2 virus, and you will therefore be asked by the competent Health Authorities to undergo mandatory home isolation and fiduciary domiciliation will also be imposed for cohabitants and close contacts. It will also have to comply with the rules indicated by the Ministry of Health and the Lazio Region for effective prevention of the spread of the coronavirus. The service is carried out in compliance with the indications of the Lazio Region, in compliance with the procedures for containing the infection provided for the carrying out of the swabs of the nasal cavities (circular of the Ministry of Health n ° 2302 OF 27/01/2020) and the procedures for the correct use of PPE by the Operator (regional note prot.n.U0218196 of 11.3.2020). MOD-PCR COV REV1 04.07.2021 PAG. 2 OF 4 INFORMED DECLARATION OF CONSENT FOR MOLECULAR NOSE-Pharyngeal SWAB RT-PCR SARS-CoV-2 The undersigned (PLEASE WRITE ONLY IN BLOCK CAPITALS) SURNAME _________________________________________________ FIRST NAME ___________________________________________ BORN ON _________________ IN _________________________________________________________________ STATE _____________ RESIDENCE ___________________________________________________________________________________________________________ DOMICILE (if different from residence) __________________________________________________________________________ HEALTH CARD / TAX CODE _______________________________________________________________________________________ (not compulsory for foreign) TELEPHONE _______________________________ EMAIL __________________________________________________________________ (PLEASE WRITE ONLY IN BLOCK CAPITALS) TYPE OF DOCUMENT/PASSPORT __________________________________ NUMBER____________________________________ (FILL IN TO INSERT IT IN THE REPORT) In relation to the request for the execution of the rhino-pharyngeal swab for the search for viral RNA SARS-CoV-2, in compliance with the guidelines of the National Bioethics Committee, the custom and the current standard for all clinical practices to carry out the sampling nasopharyngeal DECLARES 1) to have read and understood the significance of the nasopharyngeal molecular swab to detect the presence of the SARS-CoV-2 virus in the biological material collected in the nasopharynx and the protocol to which it will be necessary to undergo in case of a positive result; 2) to have read and understood the information sheet and this informed consent form, as well as the attached information relating to the processing of personal data; 3) to voluntarily undergo the execution of the nasopharyngeal molecular swab; 4) to have read and understood that their personal and personal data will be transmitted to the competent health authorities and that, whatever the outcome of the test, the related data will be entered in the COVID body RECUP regional platform; 5) to assume responsibility, in the event of a positive result of the nasopharyngeal swab, to comply with the mandatory home isolation, as required by the competent health authorities; 6) to communicate the result of the nasopharyngeal swab to your doctor, if positive; 7) that you want to receive the report via e-mail at the above address. Date, _____________________ Signature, ________________________________________________ MOD-PCR COV REV1 04.07.2021 PAG. 3 OF 4 CONSENT OF THE INTERESTED PARTY TO DATA PROCESSING The company is the data controller, pursuant to European Regulation 2016/679, the data collected will be managed in compliance with the provisions of current legislation. To perform the RT-PCR molecular swab, the Lazio Region requires that its data be entered in the regional platform "covid body" and SERESMI, and the positive cases sent to the SISP (hygiene and public health service) competent for residence and / or domicile and that the result is available online and / or sent by email. The undersigned, _________________________________________________________________________________________________ having read the information (also present on the website at the page https://www.artemisialab.it/privacy-policy-2/ on the processing of personal data, aware that the release of personal identification data is necessary for the execution of the test required: 1) [ ] Agrees [ ] Does not consent (MANDATORY IN ORDER TO CARRY OUT THE EXAM) to the processing of their personal data of a particular, "sensitive" nature, for the performance of the requested service as indicated in the information; 2) [ ] Agrees [ ] Does not consent (MANDATORY IN ORDER TO CARRY OUT THE EXAM) to the processing of personal data for ONLINE REPORTING - telephone communication of the report, sending results to the e-mail issued and consultation via the website - through the identification code P.I.D. and / or tax code); [ ] Agrees [ ] Does not consent (MANDATORY IN ORDER TO CARRY OUT THE EXAM) To the use of your data for public health purposes which provide for their insertion in the regional telematic platform "covid body" and in case of positive transmission, including via email, to the SISP (hygiene and public health service) . 3) Date, _______________________ Signature__________________________________________ MOD-PCR COV REV1 04.07.2021 PAG. 4 OF 4 Triage - Questionario Covid-19 SCHEDA DI VALUTAZIONE DA COMPILARE E PORTARE CON SE IL GIORNO DELL’ESAME Data _________________ Cognome e nome ________________________________________________________ Data di nascita _________________________ Nei 14 giorni precedenti all'accesso in ambulatorio SI NO Febbre >37.5°C Tosse Difficoltà respiratoria Difficoltà a riconoscere odori o sapori Contatti con casi accertati di COVID-19 Contatti con persone in isolamento fiduciario per COVID-19 Contatti con persone con febbre e sintomi respiratori SE SI AD UNA DI QUESTE DOMANDE o TEMPERATURA FEBBRILE NON RECARSI IN AMBULATORIO Nel caso di febbre, tosse o sintomi respiratori, si deve concordare un nuovo appuntamento. _______________________________________________________________________________________ Triage – Covid-19 Questionnarie EVALUATION FORM TO FILL IN AND TAKE WITH YOU ON THE DAY OF THE EXAM Date _________________ Surname and first name _________________________________________________________________ Date of birth _________________________Nei 14 In the 14 days prior to accessing the clinic YES NO Fever >37.5°C Cough Breathing difficulty Difficulty recognizing smells or tastes Contact with confirmed cases of COVID-19 Contact with people in fiduciary isolation for COVID-19 Contact with people with fever and respiratory symptoms IF YES TO ONE OF THESE QUESTIONS or FEBRUARY TEMPERATURE DO NOT GO TO THE AMBULATORY In the event of fever, cough or respiratory symptoms, a new appointment must be arranged.
