<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04447495</url>
  </required_header>
  <id_info>
    <org_study_id>20-001</org_study_id>
    <nct_id>NCT04447495</nct_id>
  </id_info>
  <brief_title>Self-sampling for the Study of COVID-19</brief_title>
  <official_title>Self-sampling for the Study of COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical College of Wisconsin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical College of Wisconsin</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the feasibility of self-sampling with the iAMP® COVID-19 Detection&#xD;
      Kit (Atila BioSystems, Mountain View, CA), a new, low-cost SARS-CoV-2 test that does not&#xD;
      require RNA extraction. The investigators will compare the sensitivity and specificity of the&#xD;
      iAMP® assay on self-sampled mid-turbinate, anterior nares, and saliva swabs against the gold&#xD;
      standard, a nucleic acid amplification testing assay on a clinician-collected nasopharyngeal&#xD;
      swab.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      3.1.1 Study population: The investigators will enroll patients within a larger clinical&#xD;
      validation study of the iAMP® test against the gold standard (the CDC-recommended test) until&#xD;
      we have prospectively collected a total of 100 positive cases. Current positivity in the&#xD;
      region is approximately 20%, therefore, approximately 500 samples will be needed. Inclusion&#xD;
      criteria are as follows: Patients older than 18 presenting for COVID-19 testing, able to&#xD;
      tolerate nasopharyngeal swabs, and able to follow instructions for self-collection. Exclusion&#xD;
      criteria are as follows: unable or unwilling to provide informed consent and/or reliable&#xD;
      contact information.&#xD;
&#xD;
      3.1.2 Clinical visit: Symptomatic patients will be approached by a study provider wearing&#xD;
      PPE. The study will be explained and if the patient agrees, they will be consented. Patients&#xD;
      will be allowed to consent for just the two nasopharyngeal swabs or for all five swabs. After&#xD;
      consent, each patient will undergo testing with simultaneous placement of two nasopharyngeal&#xD;
      swabs by a clinician for the large-scale clinical validation. One will be stored dry in a&#xD;
      tube and one will be placed in viral collection medium. Patients who consent to the&#xD;
      self-sampling study will be taken to a private area for collection of three different&#xD;
      samples. After receiving written instructions and watching a short instructional video, the&#xD;
      mid-turbinate sample will be collected by the patient under the supervision of a clinician.&#xD;
      The clinician will then leave and the patient will self-collect samples from the anterior&#xD;
      nares and saliva. All samples will be stored dry. When the patient returns the samples to the&#xD;
      research coordinator, they will be asked about any side effects or adverse events from the&#xD;
      mid-turbinate sample.&#xD;
&#xD;
      3.1.3 Laboratory testing: A dry swab will be collected from two of the three iAMP®&#xD;
      self-sample sites - mid-turbinate and anterior nares - and placed into a vial with the&#xD;
      proprietary buffer (hereafter referred to as Sample Buffer A). For saliva, a sterile&#xD;
      collection cup will be used for the sample collection, and Sample Buffer A will be added&#xD;
      directly to the sterile collection cup. Each of the three samples with the added Sample&#xD;
      Buffer A will incubate at room temperature for 15 minutes. A proprietary multiplex mixture&#xD;
      (master mix) will be prepared in a test tube and 10 microliters of the sample from the vial&#xD;
      (mid turbinate and nares) or cup (saliva) will be added to the test tube. The test tube will&#xD;
      then be placed into the RT-PCR machine and run to completion of the assay. The assay will be&#xD;
      resulted as either positive, negative or invalid (test to be repeated) and the result&#xD;
      compared to the anonymized result of the nasopharyngeal test run with the CDC recommended&#xD;
      NAAT assay.&#xD;
&#xD;
      Instructions for subjects on how to correctly collect the swabs from each site. [Cotton swabs&#xD;
      should be flocked and tapered].&#xD;
&#xD;
      Mid-turbinate:&#xD;
&#xD;
        -  Wash and dry hands thoroughly&#xD;
&#xD;
        -  Take a sterile cotton swab and hold it by the stem in your dominant hand&#xD;
&#xD;
        -  Open the empty iAMP collection vial and hold it in the other hand&#xD;
&#xD;
        -  Tilt your head back so chin is roughly parallel to ground (~70º)&#xD;
&#xD;
        -  Insert the cotton swab to the mark on the stem (one inch, or ~2 cm) and rotate the&#xD;
           cotton swab completely (360º) 3 times.&#xD;
&#xD;
        -  Remove the swab and without touching the cotton tip, repeat the process on the other&#xD;
           side with the same cotton swab&#xD;
&#xD;
        -  Remove the swab from the nose, do not touch the cotton tip, and place the swab, cotton&#xD;
           tip first, into the vial&#xD;
&#xD;
        -  Break off the upper stem of the cotton swab&#xD;
&#xD;
        -  Replace the cap onto the vial, closing it securely&#xD;
&#xD;
        -  Give the closed vial to the research personnel&#xD;
&#xD;
      Anterior nares:&#xD;
&#xD;
        -  Wash and dry hands thoroughly&#xD;
&#xD;
        -  Take a sterile cotton swab and hold it by the stem in your dominant hand&#xD;
&#xD;
        -  Open the empty iAMP® collection vial and hold it in the other hand&#xD;
&#xD;
        -  Insert the cotton swab into one nostril just until the cotton tip is no longer visible&#xD;
           (~0.5 inches, or 1 cm)&#xD;
&#xD;
        -  Rotate it inside the nose completely (360º) 3 times and leave it in place for 10-15&#xD;
           seconds&#xD;
&#xD;
        -  Remove the swab and without touching the cotton tip, repeat the process in the other&#xD;
           nostril, again inserting the cotton swab only until the cotton tip is no longer visible,&#xD;
           rotating it 3 times and leaving it in place for 10-15 seconds&#xD;
&#xD;
        -  Remove the swab, do not touch the cotton tip, and place the swab, cotton tip first, into&#xD;
           the vial&#xD;
&#xD;
        -  Break off the upper stem of the cotton swab&#xD;
&#xD;
        -  Replace the cap onto the vial, closing it securely&#xD;
&#xD;
        -  Give the closed vial to the research personnel&#xD;
&#xD;
      Saliva:&#xD;
&#xD;
        -  Do not eat, drink, smoke or chew gum within 30 minutes of the collection&#xD;
&#xD;
        -  Take a sterile urine cup and spit repeatedly into it until there is 2-3 milliliters of&#xD;
           liquid (excluding bubbles). See image below for example of amount of saliva needed&#xD;
&#xD;
        -  Keep inside of cup sterile by NOT placing anything (fingers, objects, etc) into the cup&#xD;
&#xD;
        -  Once adequate amount of saliva collected, place the cap onto the top of the cup and&#xD;
           close it securely&#xD;
&#xD;
        -  Give closed cup to research personnel&#xD;
&#xD;
      3.1.4 Statistical justification Assuming 20% of specimens tested with the NAAT assay will be&#xD;
      COVID-19 positive, a study of 500 consecutive specimens will yield 100 COVID-19 cases&#xD;
      detected by the NAAT assay. This study will be able to estimate the 95% confidence interval&#xD;
      (CI) for sensitivity and specificity indicated in the table below for true sensitivity and&#xD;
      specificity ranging from 50% to 95%. The precision improves the farther the sensitivity and&#xD;
      specificity differ from 50%.&#xD;
&#xD;
      Table 1: 95% confidence intervals for detecting sensitivity and specificity True Sensitivity&#xD;
      Sensitivity 95% CI True Specificity Specificity 95% CI 50% 39.8% - 60.2% 50% 45.0% - 55.0%&#xD;
      70% 60.0% - 78.8% 70% 65.2% - 74.5% 90% 82.4% - 95.1% 90% 86.6% - 92.8% 95% 88.7% - 98.4% 95%&#xD;
      92.3% - 96.9%&#xD;
&#xD;
      3.1.5 Risks/Safety The only risk of this study is the additional exposure of the laboratory&#xD;
      personnel performing the assay. All laboratorians involved are trained in handling infectious&#xD;
      agents such as COVID-19. All standard precautions will be used for the handling of the&#xD;
      specimens including aliquoting samples in a Biosafety hood and the use of Personal Protective&#xD;
      Equipment. Patient confidentiality will be assured by the anonymizing of patient samples as&#xD;
      previously approved by the MCW IRB.&#xD;
&#xD;
      3.1.6 Analysis. Sensitivity and specificity will be estimated for each iAMP® test as well as&#xD;
      corresponding 95% exact confidence intervals using the NAAT assay as the reference standard.&#xD;
&#xD;
      3.1.7 Potential Clinical Limitations&#xD;
&#xD;
        1. Alternative anatomic sites will have lower sensitivity than nasopharyngeal swabs. It is&#xD;
           possible that the self-collected swabs will have significantly lower sensitivity than&#xD;
           nasopharyngeal swabs. This is unlikely to be the case because viral load with this novel&#xD;
           virus is very high&#xD;
&#xD;
        2. Subjects may refuse to have multiple swabs taken. Patients may refuse to give 5 samples.&#xD;
           Since the self-collected sites are unlikely to cause discomfort we expect that most&#xD;
           participants will agree to study participation. Even if many patients do not agree to&#xD;
           participate there are 700 patients per day presenting with symptoms which a large pool&#xD;
           of potential participants which will make it feasible to reach our goal. The&#xD;
           investigators may need to continue enrollment until there are 100 self-collected&#xD;
           COVID-19 + subjects if some subjects refuse additional tests.&#xD;
&#xD;
      3.2 Specific Aim 2. Evaluate the incidence of adverse events in a self-collected&#xD;
      mid-turbinate sample. According to the instructions for use (IFU), mid-turbinate swabs are&#xD;
      required to be collected under medical supervision,13 which the CDC reinforces. There have&#xD;
      been multiple studies that have demonstrated that mid-turbinate samples are effective for&#xD;
      detection of other respiratory illnesses.14-17 Since mid-turbinate collection may have higher&#xD;
      sensitivity than anterior nares or saliva testing, it is important to demonstrate that it can&#xD;
      be safely collected without clinical supervision. Although some patients may be able to&#xD;
      perform a mid-turbinate collection via a telehealth visit this would be a barrier to wide&#xD;
      scale-up. Thus, the investigators will allow patients to self-collect a mid-turbinate sample&#xD;
      with a collection swab. The swab will have an indicator line signaling the mean length to&#xD;
      reach the mid-turbinate region in adults (approximately 1 inch, or 2 cms). The healthcare&#xD;
      provider will then evaluate the patient for any adverse events related to the patient&#xD;
      self-collection, such as pain and/or bleeding. If the incidence of adverse events is absent&#xD;
      or very low (less than 5%) and the sensitivity of the mid-turbinate sample is superior to the&#xD;
      anterior nares, patients could be allowed to sample their own mid-turbinate region without&#xD;
      medical supervision. The proportion of participants experiencing each type of adverse event&#xD;
      will be estimated along with a corresponding 95% exact confidence interval.&#xD;
&#xD;
      4.0 Summary The Covid-19 pandemic has created a global crisis that is affecting all sectors&#xD;
      of society. To decrease the catastrophic economic and healthcare impacts of this virus, the&#xD;
      availability of safe, inexpensive, and reliable testing will be necessary. This project aims&#xD;
      to study the self-collection of a low-cost, rapid test (iAMP®) in three anatomic areas - the&#xD;
      mid-turbinate, the nares and saliva - that, if validated, can help make widespread testing a&#xD;
      real possibility. The secondary aim is to show that all of these areas can be safely&#xD;
      self-collected without the need for clinician supervision. Decreasing barriers to Covid-19&#xD;
      testing and processing will help to mitigate this crisis and allow for a return to normal&#xD;
      activities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Validate iAMP testing kit</measure>
    <time_frame>1 month</time_frame>
    <description>Validate the iAMP® testing kit for use in the mid-turbinate, anterior nares and with saliva collection and compare the sensitivities and specificities of each site to nasopharyngeal collection.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">126</enrollment>
  <condition>Coronavirus</condition>
  <arm_group>
    <arm_group_label>SARS-CoV-2 positive</arm_group_label>
    <description>We will enroll patients within a larger clinical validation study of the iAMP® test against the gold standard (the CDC-recommended test) until we have prospectively collected a total of 100 positive cases.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Current SARS-CoV-2 positivity in the region is approximately 20%, therefore, approximately 400 negative control samples will be needed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>iAMP test</intervention_name>
    <description>The low-cost Atila BioSystems iAMP® COVID-19 Detection kit consists of a reaction buffer mix, primer mix, three sample buffer components, a positive and negative control, nasopharyngeal swabs, and sample collection vials. Each kit is suitable for 100 tests.</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>SARS-CoV-2 positive</arm_group_label>
  </intervention>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      A dry swab will be collected from two of the three iAMP® self-sample sites - mid-turbinate&#xD;
      and anterior nares.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        SARS-CoV-2 positive and negative participants&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects older than 18 presenting for COVID-19 testing&#xD;
&#xD;
          -  Subject able to tolerate nasopharyngeal swabs&#xD;
&#xD;
          -  Subjects able to follow instructions for self-collection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects younger than 18&#xD;
&#xD;
          -  Subjects unable to tolerate nasopharyngeal swabs&#xD;
&#xD;
          -  Subjects unable to follow instructions&#xD;
&#xD;
          -  Subjects unable or unwilling to provide informed consent and/or reliable contact&#xD;
             information.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juan Felix, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical College of Wisconsin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mooreland Reserve Health Center</name>
      <address>
        <city>New Berlin</city>
        <state>Wisconsin</state>
        <zip>53151</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>December 21, 2021</last_update_submitted>
  <last_update_submitted_qc>December 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical College of Wisconsin</investigator_affiliation>
    <investigator_full_name>Juan C. Felix, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04447495
org study id: 20-001
nct id: NCT04447495
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study will evaluate the feasibility of self-sampling with the iAMP® COVID-19 Detection
      Kit (Atila BioSystems, Mountain View, CA), a new, low-cost SARS-CoV-2 test that does not
      require RNA extraction. The investigators will compare the sensitivity and specificity of the
      iAMP® assay on self-sampled mid-turbinate, anterior nares, and saliva swabs against the gold
      standard, a nucleic acid amplification testing assay on a clinician-collected nasopharyngeal
      swab.
3.1.1 Study population: The investigators will enroll patients within a larger clinical
      validation study of the iAMP® test against the gold standard (the CDC-recommended test) until
      we have prospectively collected a total of 100 positive cases. Current positivity in the
      region is approximately 20%, therefore, approximately 500 samples will be needed. Inclusion
      criteria are as follows: Patients older than 18 presenting for COVID-19 testing, able to
      tolerate nasopharyngeal swabs, and able to follow instructions for self-collection. Exclusion
      criteria are as follows: unable or unwilling to provide informed consent and/or reliable
      contact information.

      3.1.2 Clinical visit: Symptomatic patients will be approached by a study provider wearing
      PPE. The study will be explained and if the patient agrees, they will be consented. Patients
      will be allowed to consent for just the two nasopharyngeal swabs or for all five swabs. After
      consent, each patient will undergo testing with simultaneous placement of two nasopharyngeal
      swabs by a clinician for the large-scale clinical validation. One will be stored dry in a
      tube and one will be placed in viral collection medium. Patients who consent to the
      self-sampling study will be taken to a private area for collection of three different
      samples. After receiving written instructions and watching a short instructional video, the
      mid-turbinate sample will be collected by the patient under the supervision of a clinician.
      The clinician will then leave and the patient will self-collect samples from the anterior
      nares and saliva. All samples will be stored dry. When the patient returns the samples to the
      research coordinator, they will be asked about any side effects or adverse events from the
      mid-turbinate sample.

      3.1.3 Laboratory testing: A dry swab will be collected from two of the three iAMP®
      self-sample sites - mid-turbinate and anterior nares - and placed into a vial with the
      proprietary buffer (hereafter referred to as Sample Buffer A). For saliva, a sterile
      collection cup will be used for the sample collection, and Sample Buffer A will be added
      directly to the sterile collection cup. Each of the three samples with the added Sample
      Buffer A will incubate at room temperature for 15 minutes. A proprietary multiplex mixture
      (master mix) will be prepared in a test tube and 10 microliters of the sample from the vial
      (mid turbinate and nares) or cup (saliva) will be added to the test tube. The test tube will
      then be placed into the RT-PCR machine and run to completion of the assay. The assay will be
      resulted as either positive, negative or invalid (test to be repeated) and the result
      compared to the anonymized result of the nasopharyngeal test run with the CDC recommended
      NAAT assay.

      Instructions for subjects on how to correctly collect the swabs from each site. [Cotton swabs
      should be flocked and tapered].

      Mid-turbinate:

        -  Wash and dry hands thoroughly

        -  Take a sterile cotton swab and hold it by the stem in your dominant hand

        -  Open the empty iAMP collection vial and hold it in the other hand

        -  Tilt your head back so chin is roughly parallel to ground (~70º)

        -  Insert the cotton swab to the mark on the stem (one inch, or ~2 cm) and rotate the
           cotton swab completely (360º) 3 times.

        -  Remove the swab and without touching the cotton tip, repeat the process on the other
           side with the same cotton swab

        -  Remove the swab from the nose, do not touch the cotton tip, and place the swab, cotton
           tip first, into the vial

        -  Break off the upper stem of the cotton swab

        -  Replace the cap onto the vial, closing it securely

        -  Give the closed vial to the research personnel

      Anterior nares:

        -  Wash and dry hands thoroughly

        -  Take a sterile cotton swab and hold it by the stem in your dominant hand

        -  Open the empty iAMP® collection vial and hold it in the other hand

        -  Insert the cotton swab into one nostril just until the cotton tip is no longer visible
           (~0.5 inches, or 1 cm)

        -  Rotate it inside the nose completely (360º) 3 times and leave it in place for 10-15
           seconds

        -  Remove the swab and without touching the cotton tip, repeat the process in the other
           nostril, again inserting the cotton swab only until the cotton tip is no longer visible,
           rotating it 3 times and leaving it in place for 10-15 seconds

        -  Remove the swab, do not touch the cotton tip, and place the swab, cotton tip first, into
           the vial

        -  Break off the upper stem of the cotton swab

        -  Replace the cap onto the vial, closing it securely

        -  Give the closed vial to the research personnel

      Saliva:

        -  Do not eat, drink, smoke or chew gum within 30 minutes of the collection

        -  Take a sterile urine cup and spit repeatedly into it until there is 2-3 milliliters of
           liquid (excluding bubbles). See image below for example of amount of saliva needed

        -  Keep inside of cup sterile by NOT placing anything (fingers, objects, etc) into the cup

        -  Once adequate amount of saliva collected, place the cap onto the top of the cup and
           close it securely

        -  Give closed cup to research personnel

      3.1.4 Statistical justification Assuming 20% of specimens tested with the NAAT assay will be
      COVID-19 positive, a study of 500 consecutive specimens will yield 100 COVID-19 cases
      detected by the NAAT assay. This study will be able to estimate the 95% confidence interval
      (CI) for sensitivity and specificity indicated in the table below for true sensitivity and
      specificity ranging from 50% to 95%. The precision improves the farther the sensitivity and
      specificity differ from 50%.

      Table 1: 95% confidence intervals for detecting sensitivity and specificity True Sensitivity
      Sensitivity 95% CI True Specificity Specificity 95% CI 50% 39.8% - 60.2% 50% 45.0% - 55.0%
      70% 60.0% - 78.8% 70% 65.2% - 74.5% 90% 82.4% - 95.1% 90% 86.6% - 92.8% 95% 88.7% - 98.4% 95%
      92.3% - 96.9%

      3.1.5 Risks/Safety The only risk of this study is the additional exposure of the laboratory
      personnel performing the assay. All laboratorians involved are trained in handling infectious
      agents such as COVID-19. All standard precautions will be used for the handling of the
      specimens including aliquoting samples in a Biosafety hood and the use of Personal Protective
      Equipment. Patient confidentiality will be assured by the anonymizing of patient samples as
      previously approved by the MCW IRB.

      3.1.6 Analysis. Sensitivity and specificity will be estimated for each iAMP® test as well as
      corresponding 95% exact confidence intervals using the NAAT assay as the reference standard.

      3.1.7 Potential Clinical Limitations

        1. Alternative anatomic sites will have lower sensitivity than nasopharyngeal swabs. It is
           possible that the self-collected swabs will have significantly lower sensitivity than
           nasopharyngeal swabs. This is unlikely to be the case because viral load with this novel
           virus is very high

        2. Subjects may refuse to have multiple swabs taken. Patients may refuse to give 5 samples.
           Since the self-collected sites are unlikely to cause discomfort we expect that most
           participants will agree to study participation. Even if many patients do not agree to
           participate there are 700 patients per day presenting with symptoms which a large pool
           of potential participants which will make it feasible to reach our goal. The
           investigators may need to continue enrollment until there are 100 self-collected
           COVID-19 + subjects if some subjects refuse additional tests.

      3.2 Specific Aim 2. Evaluate the incidence of adverse events in a self-collected
      mid-turbinate sample. According to the instructions for use (IFU), mid-turbinate swabs are
      required to be collected under medical supervision,13 which the CDC reinforces. There have
      been multiple studies that have demonstrated that mid-turbinate samples are effective for
      detection of other respiratory illnesses.14-17 Since mid-turbinate collection may have higher
      sensitivity than anterior nares or saliva testing, it is important to demonstrate that it can
      be safely collected without clinical supervision. Although some patients may be able to
      perform a mid-turbinate collection via a telehealth visit this would be a barrier to wide
      scale-up. Thus, the investigators will allow patients to self-collect a mid-turbinate sample
      with a collection swab. The swab will have an indicator line signaling the mean length to
      reach the mid-turbinate region in adults (approximately 1 inch, or 2 cms). The healthcare
      provider will then evaluate the patient for any adverse events related to the patient
      self-collection, such as pain and/or bleeding. If the incidence of adverse events is absent
      or very low (less than 5%) and the sensitivity of the mid-turbinate sample is superior to the
      anterior nares, patients could be allowed to sample their own mid-turbinate region without
      medical supervision. The proportion of participants experiencing each type of adverse event
      will be estimated along with a corresponding 95% exact confidence interval.

      4.0 Summary The Covid-19 pandemic has created a global crisis that is affecting all sectors
      of society. To decrease the catastrophic economic and healthcare impacts of this virus, the
      availability of safe, inexpensive, and reliable testing will be necessary. This project aims
      to study the self-collection of a low-cost, rapid test (iAMP®) in three anatomic areas - the
      mid-turbinate, the nares and saliva - that, if validated, can help make widespread testing a
      real possibility. The secondary aim is to show that all of these areas can be safely
      self-collected without the need for clinician supervision. Decreasing barriers to Covid-19
      testing and processing will help to mitigate this crisis and allow for a return to normal
      activities.
observational model: Case-Control
time perspective: Prospective
measure: Validate iAMP testing kit
time frame: 1 month
description: Validate the iAMP® testing kit for use in the mid-turbinate, anterior nares and with saliva collection and compare the sensitivities and specificities of each site to nasopharyngeal collection.
arm group label: SARS-CoV-2 positive
description: We will enroll patients within a larger clinical validation study of the iAMP® test against the gold standard (the CDC-recommended test) until we have prospectively collected a total of 100 positive cases.
arm group label: Controls
description: Current SARS-CoV-2 positivity in the region is approximately 20%, therefore, approximately 400 negative control samples will be needed.
intervention type: Diagnostic Test
intervention name: iAMP test
description: The low-cost Atila BioSystems iAMP® COVID-19 Detection kit consists of a reaction buffer mix, primer mix, three sample buffer components, a positive and negative control, nasopharyngeal swabs, and sample collection vials. Each kit is suitable for 100 tests.
arm group label: Controls
arm group label: SARS-CoV-2 positive
A dry swab will be collected from two of the three iAMP® self-sample sites - mid-turbinate
      and anterior nares.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Juan Felix, M.D.
role: Principal Investigator
affiliation: Medical College of Wisconsin
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical College of Wisconsin
investigator full name: Juan C. Felix, MD
investigator title: Professor
mesh term: Coronavirus Infections
sharing ipd: No