Evaluation of the INDICAID™ COVID-19 Rapid Antigen Test in Symptomatic Populations and Asymptomatic Community Testing
Conditions: Covid19
Sponsor: University of California, Los Angeles

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Clinical Performance of INDICAID COVID-19 Rapid Antigen Test 
 
Sponsor: 
Phase Diagnostics, Inc  
(PHASE) 
 
10527 Garden Grove Boulevard 
Garden Grove, CA 92843 
 
 
 
 
 
EFFECTIVE DATE: November 6, 2020 
 
For Investigational Use Only: 
The performance characteristics of this product have not been established. 
 
 
 
 
 
STATEMENT OF INVESTIGATOR 
 
In signing this page, the Principle Investigator (PI) agrees to accept this protocol and conduct this 
study in compliance with the protocol, applicable regulations, and institutional policy; maintain 
confidentiality of protocol and investigational materials; and discontinue the study at Phase’s 
request. 
 
 
 
Investigator’s Signature 
 
 
 
 
Date 
 
 
 
Investigator’s Printed Name 
 
 
 
 
Title, Institution 
 
 
 
 
 

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Table of Contents 
 
BACKGROUND / RATIONALE ................................................................................................................................. 5 
PRODUCT DESCRIPTION AND INTENDED USE ........................................................................................................ 5 
PRINCIPLE OF TEST ................................................................................................................................................... 6 
STUDY OVERVIEW ................................................................................................................................................ 6 
STUDY OBJECTIVE ................................................................................................................................................. 6 
ACCEPTANCE CRITERIA ..................................................................................... ERROR! BOOKMARK NOT DEFINED. 
STUDY DESIGN ..................................................................................................................................................... 7 
STUDY DURATION ......................................................................................................................................................... 7 
BIAS MINIMIZATION AND ELIMINATION ........................................................................................................................... 10 
STUDY PROCEDURES ............................................................................................................................................ 7 
INFORMED CONSENT ..................................................................................................................................................... 8 
STUDY PARTICIPANT ENROLLMENT AND ELIGIBILITY CRITERIA ................................................................................................. 8 
INCLUSION CRITERIA ...................................................................................................................................................... 8 
EXCLUSION CRITERIA ...................................................................................................................................................... 9 
SPECIMEN DE-IDENTIFICATION ......................................................................................................................................... 9 
STUDY PARTICIPANT WITHDRAWN OR EXCLUDED AFTER ENROLLMENT .................................................................................... 9 
SPECIMEN COLLECTION .................................................................................................................................................. 9 
INDICAID SPECIMEN COLLECTION AND TESTING PROCEDURE ............................................................................................... 9 
REFERENCE TEST SPECIMEN COLLECTION AND TESTING PROCEDURE ....................................................................................... 9 
STORAGE HANDLING AND SHIPMENT .............................................................................................................................. 10 
INVESTIGATIONAL DEVICE STORAGE AND DISPOSITION ..................................................................................... 10 
RISK / BENEFIT ANALYSIS .................................................................................................................................... 10 
POTENTIAL RISKS ASSOCIATED WITH THE STUDY ................................................................................................................ 10 
REPORTING ADVERSE EVENTS ........................................................................................................................................ 11 
DATA AND RECORDS MANAGEMENT .................................................................................................................. 11 
STUDY DATA AND RECORDS MAINTENANCE ..................................................................................................................... 11 
MONITORING PLAN ............................................................................................................................................ 11 
STATISTICAL METHODS ...................................................................................................................................... 11 
SAMPLE SIZE RATIONALE .................................................................................................. ERROR! BOOKMARK NOT DEFINED. 
STATISTICAL ANALYSIS PLAN .......................................................................................................................................... 12 
ADMINISTRATION .............................................................................................................................................. 12 
SITE QUALIFICATION .................................................................................................................................................... 12 
IRB REVIEW AND APPROVAL ......................................................................................................................................... 12 
TRAINING .................................................................................................................................................................. 12 
PROTOCOL DEVIATIONS ................................................................................................................................................ 12 
REGULATORY RESPONSIBILITIES ....................................................................... ERROR! BOOKMARK NOT DEFINED. 
REFERENCES ....................................................................................................................................................... 13 
REVISION HISTORY ............................................................................................................................................. 13 
 

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STUDY DEFINITIONS 
Abbreviations 
Definition 
AE 
Adverse Event 
BSL 
Biosafety Level 
CDC 
Centers for Disease Control and Prevention 
CI 
Confidence Interval 
COVID-19 
Coronavirus Disease 2019 
EUA 
Emergency Use Authorization 
FDA 
Food and Drug Administration 
FP 
False Positive 
FN 
False Negative 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practice 
ICU 
Intensive Care Unit 
ID 
Identification 
IUO 
Investigational Use Only 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
LFA 
Lateral-Flow Immunoassay 
LoD 
Limit of Detection 
LOS 
Length of Stay 
MERS 
Middle East Respiratory Syndrome 
NPA 
Negative Percent Agreement 
PHEIC 
Public Health Emergency of International Concern 
PHI 
Protected Health Information 
PI 
Principle Investigator 
POC 
Point of Care 
PPA 
Positive Percent Agreement 
RNA 
Ribonucleic Acid 
RT-PCR 
Reverse Transcription Polymerase Chain Reaction 
SARS-CoV 
Severe Acute Respiratory Syndrome Coronavirus 
sFTP 
Secure File Transfer Protocol 
TP 
True Positive 
TN 
True Negative 
UADE 
Unanticipated Adverse Device Effect 
US 
United States 
WHO 
World Health Organization 
 
RESPONSIBILITIES 
This section details the responsibilities of the PI, the Sponsor, and the study monitors. 
Role 
Responsibilities 

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Investigator 
• Obtain IRB approval for protocol prior to study initiation, if 
needed. 
• Conduct study in accordance with signed Statement of 
Investigator, study protocol, GCP, GLP, other applicable country 
specific regulations. 
• Submit proposed protocol amendments or deviations to IRB and 
sponsor and obtain approval. 
• Submit progress reports, final reports, and special reports to IRB, 
when applicable. 
• Supervise the use of the IUO device. 
• Permit country specific regulatory agency and Sponsor’s Clinical 
Affairs Staff to inspect facilities and records or delinked records 
as applicable. 
• Refrain from promoting investigational materials. 
• Retain study records according to Phase Diagnostics and country 
specific regulations. 
Sponsor 
(Phase 
Diagnostic 
Inc.) 
• Provide approved Study Protocol. 
• Verify investigators are qualified by training and experience. 
• Verify IRB approval of protocol has been obtained prior to study 
initiation. 
• Verify Clinical Trial Agreement has been fully executed prior to 
study initiation. 
• Select qualified monitors. 
Provide all testing materials needed for the study.  Provide Study 
Protocol, testing instructions and selection criteria for testing sites, 
operators and participants.  Approve selected testing sites and 
operators.  Data review and analysis. 
• Assign a Monitor to conduct periodic monitoring visits which 
include, but are not limited to: 
o Audit case report forms against source documents as 
appropriate and verify accuracy and completeness. 
o Document and investigate missing data. 
o Review investigator files for completeness and compliance 
with the protocol and other appropriate regulations. 
o Review adverse events/serious adverse events reports 
and comply with country specific reporting legislation, if 
applicable. 
o Prepare written reports of each visit which include but are 
not limited to: visit date; monitor name; site name; PI 
name; findings; and actions taken if any. 
o Provide consolation at Investigator’s request. 
 
 
 

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BACKGROUND / RATIONALE 
Coronaviruses are a large family of viruses that cause illness ranging from the common 
cold to more severe diseases such as MERS and SARS-CoV. A novel coronavirus 
(SARS-CoV-2) was discovered in December 2019 and has resulted in millions of 
confirmed human infections worldwide1. COVID-19, the disease brought on by the virus, 
produces symptoms in infected patients that are similar to the other viral respiratory 
diseases including fever, cough, and shortness of breath2. The median incubation time 
is estimated to be approximately 5 days with symptoms estimated to be present within 
12 days of infection3. As the number of SARS-CoV-2 infections continues to increase, 
there is growing demand for diagnostic tests that can produce rapid, accurate and 
accessible results. 
 
To help address this need, the goal of the project is to develop a low-cost, non-invasive 
rapid point-of-care diagnostic test for the qualitative detection of SARS-CoV-2 in 
respiratory specimens. Current methodology for detecting SARS-CoV-2 is a molecular-
based test that utilizes RT-PCR. This is a laborious process that requires expensive 
equipment and reagents, special training, and can take hours until test results are 
available. The PHASE Diagnostics rapid test is a qualitative lateral-flow immunoassay 
to determine the presence of SARS-CoV-2 in respiratory samples in a single hand-held 
device, with a time-to-result of 15 minutes. 
PRODUCT DESCRIPTION AND INTENDED USE 
 
The INDICAID Rapid Antigen Test Kit includes 25 individually sealed single-use Test 
Devices, 25 Buffer Solution Vials, and 25 sterile Nasal Swabs.  A Quick Reference 
Instruction Sheet is provided with each test kit. 
 
The INDICAID COVID-19 Rapid Antigen Test (INDICAID Rapid Test) is a lateral flow 
immunoassay (LFA) 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 7 days of symptom onset. 
 
 
In the USA, 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. The INDICAID 
Rapid Test)is intended 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 test is intended for use by medical professionals or trained 
personnel specifically instructed and trained in the techniques of in vitro diagnostic 
procedures and proper infection control procedures, and individuals similarly trained in 
point of care settings but who are not laboratory professionals. 
  
 

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Positive results are for the identification of SARS-CoV-2 nucleocapsid antigen. This 
antigen is generally detectable in upper respiratory samples 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 should be treated as presumptive, 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, and confirmed with a molecular assay, if 
necessary, for patient management.  
 
 
PRINCIPLE OF TEST 
The INDICAID Rapid Test is a chromatographic rapid test (approximately 20 minutes) 
that uses a sandwich immunoassay design to directly and qualitatively detect the 
presence or absence of SARS-CoV-2 nucleocapsid protein. The results of the test are 
visually interpreted. 
 
After collecting the swab, the patient’s sample is placed in the Buffer Solution Vial 
containing an extraction buffer. The sample is dispensed into the sample well of the test 
device and migrates through the test strip that contains antibodies conjugated to a 
chromophore (detector particle). This antibody-chromophore conjugate will bind to the 
nucleocapsid protein of the SARS-CoV-2 virus if present in the sample. The sample 
continues to flow through the test strip and is trapped by capture antibodies, which can 
be visually observed by the presence of the test line (“T”). 
STUDY OVERVIEW 
The purpose of this study is to evaluate the clinical performance of the INDICAID Rapid 
Test. This will be established by determining the positive percent agreement (PPA), 
negative percent agreement (NPA), and overall percent agreement (OPA) between the 
results of the test under investigation and an EUA-approved RT-PCR test, using clinical 
samples collected from COVID-19 symptomatic individuals. A minimum of 30 RT-PCR 
SARS-CoV-2 positive and 30 negative patients are required to assess the clinical 
performance. 
STUDY OBJECTIVE 
The objective of this study is to assess the clinical performance of the INDICAID Rapid 
Test device in the hands of the intended user at the point-of-care (POC) setting. 

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SITE REQUIREMENTS 
 
Target sites include point-of-care clinic and testing settings with non-laboratory 
healthcare professionals located in the US. 
 
Study sites agrees to the following: 
• Strictly adhere to the testing procedures outlined in this study protocol.  
• Obtain informed consent for each patient (participant) enrolled.  
• Provide complete and legible data and information. 
• Adhere to applicable rules of human subject protection when collect patient 
specimens (21 CFR Part 50 and 56.103(a). 
• Collect specimens in accordance with the collection method needed for the 
comparator method (RT-PCR test)  
 
STUDY DESIGN 
 
Study Duration 
This study will take place across 2 testing sites for 60 days or until patient enrollment 
targets are met (minimum of 30 RT-PCR SARS-CoV-2 positive and 30 negative 
patients). 
 
Sample Enrichment 
In order to enrich for positive patient samples, we will be enrolling patients who have 
previously been tested with an FDA EUA approved Antigen Test until we obtain the 
required 30 positive and 30 negative specimens (as tested by the comparator RT-PCR 
test). 
 
STUDY MATERIALS 
 
Provided to each site 
• INDICAID COVID-19 Rapid Antigen Test kits labeled “For Investigative Use 
Only”. 
• INDICAID COVID-19 Rapid Antigen Test Quick Reference Guide 
• Contrived samples for testing (10 positive and 10 negative) 
• Clinical study materials, forms, and templates 
 
Materials Needed (at each site) 
• Sample collection kit (comparator FDA EUA RT-PCR test) 

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STUDY PROCEDURES 
 
Informed Consent 
In order to protect the rights, safety, and welfare of subjects, the study is conducted in 
accordance with the 21 CFR 50, Protection of Human Subjects. Prior to study 
enrollment, each subject will be asked to voluntarily provide his or her oral consent after 
being provided the IRB-approved Research Information Sheet. The Investigator or 
designee will explain the nature, purpose, expected duration, and risks of study 
participation. Each potential subject will have the opportunity to ask questions and 
receive answers from personnel conducting the study. All subjects will be provided a 
copy of the Research Information Sheet.  
 
Study Participant Enrollment and Eligibility Criteria 
Study participants must meet the eligibility criteria listed below in order to be enrolled in 
the study. 
 
Inclusion Criteria 
• Study participant has provided verbal informed consent as required by reviewing 
institutional review board (IRB). The Experimental Bill of Rights will also be 
provided for all study participants enrolled in applicable states. 
• Study participant is at least 5 years of age. Participants under 18 years old 
requires parental/legal care provider consent. 
• Study participant reports at least 2 of the following COVID-19 symptoms: 
o Fever or chills 
o Fatigue 
o Sore throat 
o Congestion or runny nose 
o Cough 
o Headache 
o Diarrhea 
o Shortness of breath or difficulty breathing 
o Muscle or body aches 
o New loss of taste or smell 
o Nausea or vomiting 
• On-set of symptoms must be within 7 days. 
• Study participant has been previously tested with an FDA EUA SARS-CoV-2 
Antigen test as part of the clinic site standard of care and with test results known. 
• Study participant agrees to provide the following specimens for this study: 
o Three (3) clinician-collected nasal swabs (two swabs to perform sequential 
INDICAID Rapid Tests and a third to perform the comparator FDA EUA 
RT-PCR test. See below for sample collection instructions) 
 

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Exclusion Criteria 
• The study participant has been previously enrolled to the study 
• Participant is under the age of 5 years 
• Participant does not consent 
• Participant cannot provide the required samples 
• Patient is asymptomatic  
 
Specimen De-Identification 
Study specimens will be identified by a study-specific ID number and will not contain 
any additional protected health information (PHI).  
 
Study Participant Withdrawn or Excluded After Enrollment 
If, after enrollment, a study participant is found to have not met an inclusion criterion, 
the study participant will be withdrawn from the study and any completed test results will 
be excluded from data analyses.  
 
Operator Background 
All study operators are to be non-laboratory, healthcare professional personnel. 
Between the 2 sites a minimum of 5 operators shall be enrolled to perform the testing.    
 
Order of Specimen Collection 
Specimen collection for testing with the INDICAID Rapid Test and the comparator RT-
PCR test will take place after standard of care and will be randomly assigned. 
 
INDICAID Specimen Collection and Testing Procedure 
• INDICAID Rapid Test specimens will be collected and tested according to the 
INDICAID COVID-19 Rapid Antigen Test Quick Reference Guide.  
• Each operator shall test a minimum of 3 positives and 3 negatives 
• Operator ID, Patient ID, Date of Collection and test results (presence or absence 
of Control Line and Test Line and positive or negative results interpretation) are 
to be recorded on the Data Collection Form provided.  
• INDICAID Rapid Test results will not be disclosed to the patient. COVID-19 
disease state will be based on the Standard of Care procedures at the clinical 
site. 
 
Comparator Test Specimen Collection and Testing Procedure 
• Comparator FDA EUA RT-PCR test specimens will be collected and shipped to a 
CLIA certified laboratory, Warrior Diagnostics, Loveland Colorado (or equivalent 
site and method to be approved by Phase Diagnostics) according to the sites’ 
Standard of Care procedures for RT-PCR Testing.  
• Operator ID, Patient ID, Date of Collection and results from the laboratory testing 
service provider are to be recorded on the Data Collection Form.  

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• Comparator test results will not be disclosed to the patient. COVID-19 disease 
state will be based on the Standard of Care procedures at the clinical site. 
 
Bias Minimization and Elimination 
To minimize bias in specimen analysis by the INDICAID Rapid test, the following 
practices will be employed: 
• Each site will be identified with a numerical ID code 
• Patients eligible for the study will be screened by a separate clinic personnel not 
involved in collecting patient samples or performing the INDICAID Rapid Test. 
• Operators collecting the patient samples and performing the INDICAID Rapid 
Test shall be blinded to the result of any prior rapid antigen test or comparator 
RT-PCR test. 
 
Storage Handling and Shipment 
The specimens to be tested on the INDICAID Rapid test shall be tested immediately 
upon sample collection at the testing site with no storage of the sample. Specimens 
collected to be tested using the RT-PCR test shall be stored in the following manner: 
 
Temperature Storage 
Time Stored 
2-8°C 
Samples shipped overnight on ice packs 
within 24 hours of collection  
 
Shipping of biological samples should be done to IATA standards using the appropriate 
packing materials. 
 
INVESTIGATIONAL DEVICE STORAGE AND DISPOSITION 
Each site will be responsible for documenting the receipt, maintain proper storage and 
proper use of the INDICAID Rapid Test kits as prescribed.  Any discarded test device 
shall be documented and remaining test devices returned to Phase Diagnostics.  
RISK / BENEFIT ANALYSIS 
 
Potential Risks Associated with the Study 
 There is potential risk of exposure to the Coronavirus Disease 2019 and other 
pathogen to the site operator.  The selected site ensures that associated risks are 
mitigated by employing appropriate state and local safety measures. Refer to the CDC 
Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from 
Persons for Covid-19, https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-
clinical-specimens.html 
 

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Reporting Adverse Events 
No adverse events (AEs) are anticipated for this study. The study is performed entirely 
in vitro.  The INDICAID Rapid Test is for investigative use only and labeled accordingly.  
Test results obtained with the INDICAID Rapid Test are not reported to the appropriate 
health authorities or used as a diagnosis or determine a treatment method. 
 
If an AE or unanticipated adverse device effect (UADE) occurs during a study, the PI 
shall report the occurrence to Phase Diagnostics Clinical Affairs within 24 hours of the 
PI first learning of the event. Phase Diagnostics Clinical Affairs will evaluate the AE of 
the UADE as soon as it is received. Phase Diagnostics will report the AE or UADE 
according to local and country specific reporting requirements, all governing institutional 
review boards (IRBs), and all participating PIs.  
DATA AND RECORDS MANAGEMENT 
 
Study Data and Records Maintenance 
According to 21 CFR 812.140(d), Investigators are required to maintain records for a 
period of two years after the later of the following two dates: (1) the date on which the 
investigation is terminated or completed or (2) the date that the records are no longer 
required for purposes of supporting a premarket approval application, a notice of 
completion of a protocol development protocol, a humanitarian device exemption 
application, a premarket notification submission, or a request for De Novo classification.  
Study binders will be provided to each site to organize the required study records and 
documentation. Each site will be directly responsible for the maintenance and 
organization of the study documentation. During and after the study, all the information 
will be submitted to reviewed by Phase Diagnostics to ensure that any missing 
information is obtained or that any conflicting documentation is resolved.  
MONITORING PLAN 
Contact with the PI and study personnel will be maintained by Phase Diagnostic Clinical 
Affairs representatives primarily the Phase Diagnostic Clinical Study Monitor through 
periodic site visits, telephone calls, and e-mail. The purpose of site visits will be, verify 
adherence to the study protocol, and review all study-related documentation and 
records. A site initiation visit will be conducted to confirm preparedness for protocol 
execution, confirm satisfactory site facilities, review and clarify regulations and protocol 
requirements, and train the site personnel prior to activating the site for enrollment. On-
site and remote interim monitoring visits will be conducted as needed. A close-out visit 
will be conducted to ensure all study data and documentation is complete and accurate. 
STATISTICAL METHODS 
This section describes the overall approach to data analysis. This proposed design 
enables evaluation of variance over various factors. All data analysis will be performed 
in accordance with general principles espoused in CLSI EP124. 
 

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Statistical Analysis Plan 
 
Reference Test RT-PCR 
INDICAID 
COVID-19 
Rapid Antigen 
Test 
 
Infected 
Not Infected 
Total 
Positive 
TP 
FP 
TP+FP 
Negative 
FN 
TN 
FN+TN 
Total 
TP+FN 
FP+TN 
TP+FP+FN+TN 
TP = true positive 
TN = true negative 
FP = false positive    
FN = false negative 
PPA = TP/(TP+FN) 
NPA = TN/(TN+FP) 
OPA = (TP+TN)/Total Samples 
 
The following performance characteristics will be computed: PPA, NPA, OPA and 
accuracy. The 95% confidence interval for these performance characteristics will be 
computed using Wilson-Score method.  
ADMINISTRATION 
Site Qualification 
All sites will be assessed and approved by PHASE staff prior to the start of the study to 
ensure that each site has the proper procedures, equipment, and personnel in place to 
conduct the trial in accordance with the approved protocol and to abide by the principles 
of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and applicable 
United States Food and Drug Administration (FDA) regulations. The sponsor reserves 
the right to disqualify any site for failure to follow the study protocol, and substitute with 
a new site that meets these and other study protocol requirements.  
 
IRB Review and Approval 
Institutional Review Board approval will be obtained for the study protocol. 
 
Training 
Site personnel shall be trained prior to performing any study procedures. Training shall 
include, but is not limited to, the study protocol, personnel responsibilities, specimen 
documentation, data recording and reporting, specimen handling and shipping, and 
transmission of the data to Phase Diagnostics. 
 
Protocol Deviations 
Deviations from the study protocol is not allowed.  Any proposed (planned) deviation will 
be documented by the Site Administrator or PI. PHASE will review and assess the 
proposed deviation prior to approving/rejecting the deviation.  Unplanned deviation will 
be documented and reported to the PI and Phase.  Phases will determine whether or 
not the deviation has affected the validity of any associated results. 

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REFERENCES 
1.  
Johns Hopkins University, Coronavirus Resource Center. 
https://coronavirus.jhu.edu/. Accessed October 3, 2020. 
2.  
Centers for Disease Control and Prevention. Coronavirus disease 2019 (COVID-
2019). https://www.cdc.gov/coronavirus/2019-ncov/symptoms-
testing/symptoms.html. 
3.  
Lauer SA, Grantz KH, Bi Q, et al. The Incubation Period of Coronavirus Disease 
2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and 
Application. Ann Intern Med. 2020;172(9):577-582. doi:10.7326/M20-0504 
4.  
NCCLS. User Protocol for Evaluation of Qualitative Test Performance; Approved 
Guideline. NCCLS Document EP12-A [ISBN 1-56238-468-6]. NCCLS, 940 West 
Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA; 2002. 
 
REVISION HISTORY 
Revision Number Effective Date 
Summary of Changes 
Author 
1.0 
November 6, 2020 
New protocol