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Aviso Consentimiento ENG

The document is a consent form for a Covid-19 rapid antigen test. It outlines 10 points for the patient to acknowledge: 1) the test procedure and purpose are explained, 2) all questions are answered, 3) the test has limitations in accuracy, 4) test results and interpretation are explained, 5) information exchanged does not create a doctor-patient relationship, 6) results cannot determine therapy success, 7) the patient releases the company from responsibility for results, 8) personal data processing is authorized, 9) provided information is true, and 10) potential side effects are acknowledged but not dangerous.

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Miguel Hernandez
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0% found this document useful (0 votes)
69 views3 pages

Aviso Consentimiento ENG

The document is a consent form for a Covid-19 rapid antigen test. It outlines 10 points for the patient to acknowledge: 1) the test procedure and purpose are explained, 2) all questions are answered, 3) the test has limitations in accuracy, 4) test results and interpretation are explained, 5) information exchanged does not create a doctor-patient relationship, 6) results cannot determine therapy success, 7) the patient releases the company from responsibility for results, 8) personal data processing is authorized, 9) provided information is true, and 10) potential side effects are acknowledged but not dangerous.

Uploaded by

Miguel Hernandez
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Covid-19 Rapid Testing - Patient Consent Form

Date: ____________________________ Place: _____________________________________________________________

Patient Information

Name: _________________________________________________ Date of Birth: _________________________________

I declare that I have freely and voluntarily requested the in vitro diagnostic rapid test for the qualitative detection of
the SARS-CoV-2 antigen (Ag) in human nasopharyngeal swab samples (hereinafter the "Test").

Therefore, I acknowledge and declare that:

1. Test Application. The Test will be performed by a healthcare professional who has given me complete, sufficient
information in detail, in simple and clear language, about the nature, purpose, procedures, possible benefits and risks
of the Test, as well as of the disease caused by SARS-CoV2, of the meaning of the suspected or confirmed coronavirus
COVID-19 case in terms of its clinical presentation, transmission, measures to contain it, possibility of contracting the
disease and suffering complications or death.

I have been informed that the Test is indicated for people who are within the first seven days of the onset of
symptoms that correspond to a suspected COVID-19 case, and less than a week of symptom onset evolution.

2. Questions regarding the procedure. All questions that I had related to this disease have been answered.

3. Test precision. I acknowledge that the Test is not completely accurate, that there may be a margin of error, as
indicated in the following accuracy assessments:

a. Sensitivity: 93.3% (98.2% for samples with Ct ≤33)


b. Specificity: 99.4%

4. Test interpretation and results. I have been informed of the following specifications regarding Test results and
interpretation:

The Test does not substitute the utility and use of molecular tests (RT-PCR). The Test provides preliminary analysis
results.

A POSITIVE antigen test result can be used to confirm COVID-19 in people with symptoms that correspond to a
suspected case of COVID-19.

A NEGATIVE result does not rule out the SARS-CoV-2 infection and cannot be used as the sole basis for treatment.
Thus, a negative result must be combined with clinical observations, patient history, and epidemiological information.

The Test is not designed to be used as a donor screening test for SARS-CoV-2.

I declare that I have been informed that the Test result is my responsibility, were it carried out without the
symptoms described in paragraph 1, and that a negative result does not rule out the SARS-CoV-2 infection.
Therefore, it cannot be used as the sole basis for treatment or other management decisions.

5. Exchange of information. I accept that the information exchanged between the healthcare professional and myself,
during and after the completion of the Test, does not create a doctor-patient relationship, nor does it create any
relationship that could cause any kind of liability.

6. Test independence. I have been advised that the Test result cannot be used to determine the success or failure of any
therapy.
Covid-19 Rapid Testing - Patient Consent Form

7. Results. The results were communicated to me based on the health protocol that was explained to me, so I hereby
release Grupo Farmacias del Ahorro and any of its subsidiaries from all responsibility and declare that I will not take
any legal action against them.

8. Privacy notice. Comercializadora Farmacéutica de Chiapas, S.A.P.I. de C.V. and affiliate or subsidiary companies
(hereinafter “Farmacias del Ahorro”), with domicile to hear and/or receive notifications at Insurgentes Sur No. 1605,
Piso 16, Módulos 3 y 4, Colonia San José insurgents, Delegación Benito Juárez, C.P. 03900, Mexico City, is the
Responsible Party for the processing of personal data, including sensitive and personal data provided by the Data
Owner.

I may, at all times, exercise my ARCO (access, rectification, cancellation or opposition) rights regarding my personal
data by submitting a form provided for such purpose to the contact details below:

• E-mail: derechosarco@[Link]
• On-site: Insurgentes Sur No. 1605, Piso 16, Módulos 3 y 4, Colonia San José Insurgentes, Delegación Benito Juárez, C.P.
03900, Mexico City.

Under the provision of Articles 8 and 9 of the Federal Law on Protection of Personal Data Held by Private Parties I
hereby authorize, in accordance with the privacy notice, the creation of a record of the Test location, and the use of
my information for epidemiological reporting and monitoring within the framework of the applicable laws, and for
reports in the Single Information System for Epidemiological Surveillance (SUIVE). I authorize my test results to be
disclosed to any government entity as may be required by law.

9. Information. I declare that the information I provided to health professionals contained herein, as well as in the
questionnaires or health forms filled out for or during the Test, is true.

10. Side effects. I acknowledge that various reactions may be triggered at the time of the application of the Test or
subsequently, for example: pain, fear, stress, irritation on the skin where the sample is taken. However, they do not
represent any danger to my life or function.

I agree to inform the hotel where I am staying about a positive Test result so they can provide medical assistance, as
well as take the necessary health measures established by law.

I authorize the healthcare professional to perform the Test by granting my consent in the terms contained herein.
Covid-19 Rapid Testing - Patient Consent Form

For underage children or persons with disabilities:

_____________________________________ _____________________________________
Name of the personal data owner Name of the underage child or person with
disabilities, owner of the personal data.

_____________________________________
Signature of the personal data owner Name and signature of the parent or tutor of the
underage child or person with disabilities

Name: _____________________________________

Signature: _____________________________________

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