Dräger Antigen Test SARS-CoV-2 Clinical Performance Study
Phase: NA
Conditions: Covid19
Sponsor: Drägerwerk AG & Co. KGaA

Dräger Antigen Test SARS-CoV-2 
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Clinical Performance of  
Dräger Antigen Test SARS-CoV-2 
Clinical Performance Study Protocol 
NCT04698993

CONFIDENTIAL
Dräger Antigen Test SARS-CoV-2
Clinical Performance Study Protocol SARS-CoV-2-AT_01
PROTOCOL AGREEMENT & SIGNATURES
Principal Investigator
I have read and understood the protocol below. In my capacity as Principal Investigator, my 
duties include making sure of the safety of the study participants enrolled by supervising them 
and providing Dräger (Sponsor) with complete and timely Information. This Information will be 
provided as outlined in this study protocol. All the Information relating to this study will be held 
in strict confidence and these confidentiality requirements apply to all staff at this study site or 
involved with this study. I agree to maintain the procedures required to perform this study in 
accordance with Good Clinical Practice principles and to abide by the terms of this protocol.
Principle Investigator Signature
Date
3«. JW..',/ ( leier
Name and Title (Print)
Sponsor
The signatories agree to fully comply with the Clinical Performance Study Protocol, 
all applicable national regulatory requirements for medical devices/IVD, the international 
Standards of Good Clinical Practice (ICH-GCP) and the ethical principles of Declaration of 
Helsinki.
r\
Name and Title (Print)
Version CPSP-02 
11-FEB-2021
Page 2 of 21

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TABLE OF CONTENT 
PROTOCOL AGREEMENT & Signatures .............................................................................. 2 
PROTOCOL SYNOPSIS ....................................................................................................... 4 
1. 
Introduction ................................................................................................................. 6 
2. 
Study Design .............................................................................................................. 6 
3. 
Study Objectives ......................................................................................................... 7 
3.1 Primary Objectives ....................................................................................................... 7 
3.2 Secondary Objectives .................................................................................................. 7 
4. 
Study procedure ......................................................................................................... 8 
4.1 Study Enrollment Procedures ....................................................................................... 8 
4.2 Inclusion and Exclusion Criteria ................................................................................... 8 
4.3 Testing ......................................................................................................................... 9 
4.4 Collection of results .....................................................................................................10 
4.5 Reporting ....................................................................................................................10 
5. 
Deviations, Adverse events, and safety .....................................................................10 
5.1 Deviations ...................................................................................................................10 
5.2 Adverse events ...........................................................................................................11 
5.3 Criteria for interruption or early termination of the study: .............................................12 
5.4 Documentation requirements ......................................................................................13 
5.5 Notification requirements ............................................................................................13 
6. 
Statistical and Analytical Considerations ....................................................................13 
6.1 Case number estimation .............................................................................................14 
6.2 RT-PCR, cycle thresholds and viral concentration ......................................................15 
6.3 Assessement of primary objective ...............................................................................15 
6.4 Assessment of secondary objectives ..........................................................................16 
7. 
Data Quality Assurance .............................................................................................16 
7.1 Training of study staff ..................................................................................................16 
7.2 Case Report Form (CRF) ............................................................................................16 
7.3 Archiving/Record retention ..........................................................................................17 
7.4 Monitoring ...................................................................................................................17 
7.5 Audits ..........................................................................................................................17 
7.6 Privacy ........................................................................................................................17 
8. 
Ethics and regulatory requirements ............................................................................17 
9. 
Study Team ...............................................................................................................18 
9.1 Site and sponsor representatives ................................................................................18 
9.2 Funding .......................................................................................................................18 
10. 
Publication .................................................................................................................18 
11. 
References ................................................................................................................19 

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PROTOCOL SYNOPSIS 
STUDY TITLE 
Dräger Antigen Test SARS-CoV-2 Clinical Performance Study 
SPONSOR 
Drägerwerk AG & Co. KGaA, Lübeck, Germany 
PROJECT LEAD 
Dr. Rainer Polzius 
NUMBER OF SITE 
20-GER-01 
RATIONALE 
The Dräger Antigen Test SARS-CoV-2 is a rapid lateral flow immunoassay for the 
qualitative detection of SARS-CoV-2 nucleoprotein directly from minimally invasive 
nasal swabs directly at the point of care. The coronavirus SARS-CoV-2 can cause a 
mild to severe respiratory illness, i.e. COVID-19, and has spread globally. Already 
existing rapid tests are mostly based on invasive nasopharyngeal sampling and 
involve cumbersome sample extraction procedures requiring well trained users. Given 
the simple and less invasive sampling methodology of the Dräger rapid test, it is 
worthwhile to execute the proposed study as no harm is expected for the participants 
and a rapid and easy test is to be gained. 
STUDY DESIGN 
Prospective, monocentric, clinical performance evaluation study for an IVD 
PRIMARY 
OBJECTIVE 
Determine general sensitivity and specificity of the Dräger Antigen Test SARS-CoV-2 
in symptomatic participants in comparison to the reference method RT-PCR (at a 
threshold of ≥ 106 RNA copies/mL for positive PCR results) 
SECONDARY 
OBJECTIVE(S) 
• 
Sensitivity and specificity of the test under evaluation in relation to the ct value 
of the reference test 
• 
Sensitivity and specificity of the test under evaluation in relation to the time since 
symptom onset 
• 
Specificity of the test under evaluation in at least 100 asymptomatic participants 
• 
Frequency of nosebleed or unbearable pain during or immediately after 
specimen collection 
 
INTERVENTIONS 
No therapeutical interventions, no randomization 
NUMBER 
OF 
PARTICIPANTS 
approximately 850 
PROCEDURE 
Female and male adults with a pre-existing need for SARS-CoV-2 testing undergo 
screening for study participation suitability at the study site.  
Two separate sets of participants are included: persons with COVID-19 symptoms 
(symptomatic group) and persons who might have been exposed to SARS-CoV-2 but 
show no symptoms (asymptomatic group). Participants are required to meet all 
inclusion criteria and none of the exclusion criteria. All participants are tested with the 
Dräger Antigen Test SARS-CoV-2. 
RT-PCR results for pharyngeal swabs from the same participants serve as reference. 
This test is not initiated on the Sponsor’s behalf; rather the Sponsor asks the 
participants to allow the PI to share pseudonymized PCR results as reference to 
compare to the results generated by the investigational product. All test results are 
collected for performance analysis of the Dräger Antigen Test SARS-CoV-2. 
Criteria for early study termination have been defined to avoid unnecessary strain for 
participants. 

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PARTICIPANT 
SELECTION 
CRITERIA 
 
Inclusion 
Exclusion 
General 
• ≥ 18 y old 
• Written informed consent (ability 
& execution) 
• Pre-existing need for SARS-CoV-
2 testing, i.e. 
o COVID-19 symptoms 
o Known or suspected 
exposure to SARS-CoV-2 
o Screening  
• < 18 y old 
• Pregnant or breast-
feeding women 
• Unable to provide 
informed consent 
• Bleeding disorder 
• Application of nasal 
spray prior to testing 
on the day of testing 
• Involuntarily held in an 
institution 
• Hospitalization/ 
inpatient 
Specific 
Asymptomatic 
• Asymptomatic during the 
previous 14 days 
• COVID-19 symptoms 
during the previous 14 
days 
Symptomatic 
• COVID-19 symptom(s) present 
on the day of testing 
• Symptoms started 0-7 days prior 
to testing day 
• Symptom(s) started 
more than 7 days prior 
to testing day 
 
PRODUCT UNDER 
INVESTIGATION 
Dräger Antigen Test SARS-CoV-2 
The investigational product is comprised of a sample collector and a test cassette. 
The sample collector retrieves the specimen from the anterior nose, while the test 
cassette analyzes the sample for the presence of SARS-CoV-2 nucleoprotein. 
COMPARATOR 
RT-PCR specific for coronavirus SARS-CoV-2 
Pharyngeal swabs are collected using the Cobas PCR Media Uni Swab Sample Kit 
(Roche). Samples are analyzed using the PCR-Kit Cobas SARS-CoV-2 (Roche). For 
scoring the PCR result negative or positive, a cycle threshold (ct) value is used. 
Unless otherwise indicated, this study scores a PCR result with a viral concentration 
of ≥ 106 RNA copies/mL as positive and < 106 copies/mL as negative. For data 
analysis, the corresponding ct value is provided based on PCR system calibration. 
DURATION OF PARTICIPATION AND STUDY DURATION 
SCREENING 
Study staff identifies eligible patients over the course of a month. If needed, this period 
can be extended. 
TREATMENT 
Specimens for the Dräger test and comparator method are collected during the same 
one patient visit.  
FOLLOW-UP 
None needed. 
OVERALL 
DURATION 
January – March 2021, active phase 1 month 
 
 
 
 

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1. INTRODUCTION 
Coronaviruses are a large family of viruses which may cause illness in animals or humans 
(Masters, 2006; Weiss & Leibowitz, 2011). SARS-CoV-2 is an enveloped, single-stranded RNA 
virus of the β genus (Hasöksüz et al., 2020). The virus can cause a mild to severe respiratory 
illness named COVID-19 and has spread globally. 
Several rapid tests have been developed based on immunochemical detection of viral 
nucleoprotein. The advantage of faster time to result compared to PCR testing and therefore 
earlier initiation of contact tracing is a great added benefit of rapid antigen tests (van Beek et 
al., preprint). Most of these tests are executed at the point of care by experienced users and 
allow for detection of an infection with SARS-CoV-2 in patients within the first 5 to 7 days since 
symptom onset. 
Examples of existing rapid antigen tests: 
• 
BinaxNOWTM COVID-19 Ag CARD (Abbott): 
https://www.fda.gov/media/141570/download 
• 
Veritor™ System (Becton, Dickinson): https://www.fda.gov/media/139755/download 
• 
Standard Q Covid-19 Ag Test (SD Biosensor): https://bestbion.com/wp-
content/uploads/2020/07/bestbiondx_GA_standardq_COVID-19-IgM-IgG-
Duo_Ag20200713.pdf 
• 
Biocredit Covid-19 Ag Test (Biocredit): https://www.biovendor.com/file/13419/1-
2%20IFU_COVID-19%20Ag%20RapigenWatermarked.pdf?version=202005131414 
The above-mentioned rapid tests are mostly based on an invasive nasopharyngeal sampling 
procedure and involve cumbersome sample extraction procedures requiring well-trained 
operators.  
The Dräger Antigen Test SARS-CoV-2 is a rapid lateral flow immunoassay for the qualitative 
detection of SARS-CoV-2 nucleoprotein directly from less invasive nasal swabs, to be 
performed at the point of care. The test kit contains all components required to carry out a test 
detecting SARS-CoV-2 nucleoprotein. 
Given the less invasive sampling procedure and the straight-forward, fast testing procedure of 
the Dräger Antigen Test SARS-CoV-2, it is worthwhile to execute the proposed study as there 
is no harm expected for participating patients (see p. 10 for details). This study is designed as 
a non-interventional study, i.e. none of the Dräger test results are used to justify any patient 
management decisions.  
 
2. STUDY DESIGN 
The study is designed as a prospective, monocentric, clinical performance evaluation study. It 
is designed to demonstrate suitability of the Dräger Antigen Test for SARS-CoV-2 
nucleoprotein detection in clinical nasal specimens. Real-time reverse transcriptase 
polymerase chain reaction (RT-PCR, here also short PCR) on specimens collected by 
pharyngeal swabs serves as a reference method for all participants of this study. In fact, 
participants are recruited from people presenting themselves for SARS-CoV-2 testing 
(pharyngeal swab and PCR) at designated testing locations of the study site. Each participant 
must meet all inclusion criteria of the respective group (i.e. symptomatic or asymptomatic). For 
details on the reference method and scoring (cut-off) refer to 4.3 and 6.2 below. 
The goal of the study is to compare Dräger test results to the corresponding PCR data for 
overall sensitivity and specificity. Assuming a 20% PCR positive rate at the study site 
(prevalence), a 90% Dräger test sensitivity as the expected sensitivity, allowing room for 

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dropouts, and ensuring inclusion of at least 100 asymptomatic cases approx. 850 participants 
have to be enrolled (for details see case number estimation in 6).  
Dräger provides approximately 900 Dräger test kits for this study to allow for practice runs and 
error. Should more testing become necessary after review of the half-way point or the endpoint, 
plans are made accordingly. When 425 data pairs of Dräger test and PCR results are available, 
the study reaches its half-way point. All data relevant for overall sensitivity and specificity are 
analyzed, and a brief overview of results serves as a preliminary summary at this point of time. 
Data relevant for secondary objectives are analyzed at the end of the study. 
If people agree to participate, study staff records participants’ information such as symptoms 
and time since symptom onset. For each study participant, the specimen for RT-PCR is 
collected first, then the Dräger test specimen. The participants self-sample the specimens 
using the Dräger sample collector closely supervised and guided by a qualified operator. 
Should the participant be compromised in some way such that self-sampling is not an option, 
the operator may collect the sample. The time of specimen collection for each test is recorded 
in the case report form (CRF) The Dräger test result is read after 15 min to 20 min, while the 
specimen for PCR is stored for further processing at a later time. Ideally, resulting data points 
are normally distributed along the age, gender, number of days with symptoms, and cycle 
threshold (ct) value or viral concentration spectrum. 
 
3. STUDY OBJECTIVES 
3.1 Primary Objectives 
The primary objective of this study is to determine the levels of sensitivity and specificity of the 
Dräger Antigen Test SARS-CoV-2 based on direct nasal samples collected with the dedicated 
sample collector from symptomatic individuals requiring SARS-CoV-2 testing. The Dräger test 
result is compared to the reference method, that is RT-PCR. This study scores a PCR result 
of ≥ 106 RNA copies/mL (viral concentration) as positive (RKI, 2020a). The diagnostic 
laboratory analyzing the PCR samples for this study determines the corresponding cycle 
threshold (ct) value for their system. 
3.2 Secondary Objectives 
In addition to the primary objective the following secondary objectives are investigated: 
Sensitivity and specificity (and CI for CL of 95%) of the Dräger Antigen Test SARS-CoV-2 are 
determined for  
• 
both the symptomatic and asymptomatic groups, 
• 
case groups sorted by ct value, and  
• 
case groups sorted by days since symptom onset. 
Goal is to explore the data and describe the relationship between the respective parameter 
and Dräger test performance. 
The occurrence of lasting nosebleed or unbearable pain during or immediately after specimen 
collection is recorded for each participant. The frequency is monitored throughout the study. 
Its final value is presented in the study report. 

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4. STUDY PROCEDURE 
4.1 Study Enrollment Procedures 
Participants are presented for SARS-CoV-2 testing to medical staff. In order to determine 
whether a participant is eligible for this clinical study, candidates are asked to provide some 
information via questionnaire (see Case Report Form [CRF] for details) and consent to study 
participation. Participants are recruited from both symptomatic and asymptomatic people 
based on criteria detailed below.  
4.2 Inclusion and Exclusion Criteria 
If inclusion criteria are not met, the participant is excluded from the study. 
Inclusion criteria of individuals 
• 
Participants must require SARS-CoV-2 testing for the following reasons: 
o COVID-19 symptoms (Fever, cough and/or sore throat, fatigue/ general feeling 
of weakness, loss of sense of smell and/or taste, shortness of breath, muscle 
stiffness/ body aches, head cold/ running nose, etc.) on the day of testing, or 
o Known or suspected exposure to SARS-CoV-2 (contact persons etc.), or 
o Member of a group of high risk of exposure such as healthcare workers etc., or 
o Require screening for any other reason, e.g. doctor’s orders, hygiene directive 
etc. 
• 
Participant must be of legal age and must be able to understand the procedure and 
letter of consent. 
• 
Patient provides written consent prior to enrollment. 
Exclusion criteria of individuals 
• 
Persons younger than 18 years old are excluded from the study. 
• 
Pregnant or breastfeeding women are excluded from the study. 
• 
Persons unable to provide written informed consent are excluded. 
• 
Persons with bleeding disorder are excluded from the study as a precaution.  
• 
Persons in institutions where they are (involuntarily) held due to an official order or a 
court order are excluded from the study. 
• 
Hospitalized patients/inpatients are excluded. 
• 
Application of nasal spray within 15 min prior to testing. 
• 
Participants with symptoms on the day of testing are excluded, if any of their symptoms 
started more than 7 days prior to testing. 
• 
Asymptomatic participants are excluded, if they experienced any symptoms in the 14 
days prior to testing. 
Inclusion of Dräger test samples/data 
All data is presented and assessed in the study report. Only results with both valid Dräger test 
and valid PCR results are included in the data set for clinical performance assessment. A 
Dräger Antigen Test SARS-CoV-2 result is valid when: 
• 
Pouch intact upon visual inspection, 
• 
Desiccant bag present, 
• 
Kit not expired, 
• 
All components (sample collector, test cassette) present, 
• 
Kit appears undamaged and ampoule is intact (no leaking apparent), 
• 
Indicator ring is colored prior to testing, 
• 
Results were read according to this study protocol. 
 

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4.3 Testing 
Operators are trained in applying the Dräger test according to the instructions for use prior to 
collecting samples for this study. Training is acknowledged in writing. Patients who consent to 
participate in this study do not only provide a specimen for their planned PCR testing, but also 
for testing with the investigational product, the Dräger Antigen Test SARS-CoV-2. 
Specimen collection 
Trained clinic staff collect specimens for the Dräger test and for RT-PCR. For each sample, 
they follow instructions for use provided for this study or the site’s standard operating 
procedure (SOP) for the Dräger test and RT-PCR, respectively. Samples are collected and 
treated as instructed, i.e. the Dräger test is run immediately and read after 15-20 min, while 
the sample for PCR is stored according to SOP until further processing.  
Reading the Dräger Antigen Test SARS- CoV-2 results 
The analytical detection limit of the Dräger Antigen Test SARS-CoV-2 is at 250 pg/test, i.e. 
with ≥ 250 pg of SARS-CoV-2 nucleoprotein present, a test line is visible. The following 
provides guidance on how to score the Däger test results. For additional detail refer to the 
Instructions for Use and the Investigator’s Brochure. 
Test strips are evaluated 15-20 min after starting the test. The viewing window of the test 
cassette holds the test strip (Fig. 1, below). One end of the strip is the designated control line 
area, while the other is the designated test line area. Both areas are indicated with C and T, 
respectively. 
 
Figure 1. Viewing window with test strip and C and T line area labels; C = control line area, T = test line 
area. 
Positive test result 
If red control and test lines are present, the test result is positive. The intensity of the test lines 
can vary, meaning that very weak, partially colored or broken test lines are also scored as 
positive.  
Negative test result 
Test results are read 15 min after starting the test at the earliest and 20 min after starting the 
test at the latest. If – within this defined window of time - a control line is present while no test 
line is visible, the test result is negative. 
Invalid 
If neither a control nor a test line is present within 20 min of starting the test, the result is invalid. 
PCR 
Samples for PCR are processed in the diagnostics laboratory on site following routine 
procedures as described in Corman et al. (2020), Lindner et al. (in press), and Matheussen et 
al. (2020). In brief, the Roche Cobas SARS-CoV-2 assay (Pleasanton, CA United States) is 
performed.  

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RT-PCR specific for SARS-CoV-2 and the Cobas PCR assay specifically are considered a 
suitable reference method because of their e.g. high sensitivity, high specificity, low false-
positive rate (Matheeussen et al. 2020, cobas SARS-CoV-2 IFU). As a quantitative assay it 
delivers information on the viral load for each sample, which allows test performance 
evaluation in relation to viral load in this study. 
4.4 Collection of results 
The study staff records patient and testing information (mostly by checking boxes) in the 
respective CRF: 
• 
Age 
• 
Gender 
• 
Any COVID-19 symptoms? If yes, which and since when? 
After Dräger Test specimen collection, the participants indicate the pain level of sample 
collection (none, light, strong, or unbearable), which is recorded in the CRF. Dräger Test 
results (positive, negative, or invalid) are entered on the corresponding CRF directly after 
testing. They are not shared with the participants and do not inform any steps regarding 
patient/participant management. If feasible, the information is also collected electronically. 
PCR samples are processed within 72 h of sampling. PCR results are processed according to 
the Corona Test Center’s regular procedures. They include the information of patients and 
authorities where applicable. If feasible, the information is also collected electronically.  
4.5 Reporting 
The PI is responsible for making the following reports available to the Sponsor. 
Table 1. Overview 
Report 
Content 
Daily Update 
• 
No. of participants enrolled 
• 
Dräger test results per participant 
• 
Information regarding pain and nosebleed 
• 
PCR result per participant; as many results as are 
available at the time of reporting 1  
Weekly Summary 
• 
Summary of daily data 
• 
Symptoms; days since testing (counts for 0-7 
days and overall) 
• 
Ct value (or viral concentration) 
• 
Consent status per patient 
• 
AE summary 
Half-way Report 
• 
Due after 425 test result pairs were collected 
• 
Content as in Weekly Summary 
Final Report 
Compilation and review of all  
1 – PCR results are provided with a lag time of 1-3 days compared to Dräger test results. 
 
5. DEVIATIONS, ADVERSE EVENTS, AND SAFETY 
5.1 Deviations 
Deviations are defined as divergences from the Clinical Performance Study Protocol and must 
be reported and explained. The CRF is the preferred place to indicate a one-time deviation 
from the standard procedure. Should general (systemic and/or repeating) issues occur and 
have been identified as such, the PI is to inform the Sponsor’s representative immediately. For 
an overview on documentation and notification requirements see below (p. 13). 

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5.2 Adverse events 
The term adverse event (AE) describes events related to study activities for the performance 
evaluation of medical devices. It refers to undesirable, negative events such as injuries or 
diseases observed over the course of the study. General categories are presented and defined 
in Tab. 2 and Tab. 3, respectively, below. 
Table 2. General categories of adverse events as defined by ISO 20916 
Adverse events 
Non-device-related 1 
 - Sampling procedure causes direct 
harm to participant - 
Device-related 
- Device causes direct harm to user or 
another person - 
Non-serious 
Adverse event 
Adverse device effect 
Serious 
Serious adverse event 
Serious Adverse device effect 
Anticipated 
Unanticipated 
1 Note: The Dräger Test kit includes the sampling device, i.e. the sample collector. That means that the sampling – unlike other 
IVD devices that may require a swab or blood draw - is part of the device-related procedure. 
Table 3. Definition of adverse events categories. Definitions apply to studies subject to approval as well 
as studies with exemption from approval. 
AE Category 
Definition 
Adverse Event, AE 
Any untoward medical occurrence, unintended 
disease or injury in participants, operators or 
other persons 
Adverse Device Effect, ADE 
Adverse event related to the use of the Dräger 
test kit resulting from  
- 
insufficient or inadequate 
o 
instructions for use, 
o 
operation, or 
- 
malfunction 
Serious Adverse Event, SAE 
adverse event (study-related, but not necessarily 
device -related) that led to any of the following 
- 
death, 
- 
serious deterioration of health of the 
participant, operator or other persons 
including but not limited to life-threatening 
illness or injury,  
- 
fetal distress, fetal death or congenital 
abnormality or birth defect. 
Serious Adverse Device Effect, SADE 
Adverse device effect that has resulted in any of 
the consequences characteristic of a serious 
adverse event (see above) 
Anticipated Serious Adverse Device Effect, 
ASADE 
Effect which by its nature, incidence, severity or 
outcome has been identified in the risk analysis 
report 1 
Unanticpiated Serious Adverse Device Effect, 
USADE 
Serious adverse device effect which is by its 
nature, incidence, severity or outcome has not 
been identified in the current version of the risk 
analysis report 
1 See Tab. 4 and Risk Analysis Report for details specific for this study. 
Overall, anticipated adverse events have been mitigated based on the current risk assessment 
(see Tab. 4 below).  
Moreover, in an in-house study at Dräger with 46 individuals who were asked to score the 
experience of specimen collection with the Dräger sample collector as pleasant, neutral, non-
pleasant, painful or severely injuring, most participants described it as neutral (Reference 11.5, 
Report on Usability of Sampling Unit). Two participants scored the sampling as non-pleasant, 
while nobody reported it as painful or experienced severe injuries. In 1 out of 46 individuals 
traces of blood were discovered on the sample collector; yet, this individual did not suffer from 
persistent bleeding after the sampling procedure.  

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Despite the fact that the nasal sample collection is less common than e.g. nasopharyngeal 
sampling, the sample collector itself has been used successfully for > 5 years in commercial 
test kits for saliva collection at the buccal mucosa for abusive drugs testing (Dräger DrugCheck 
3000). More than 600000 tests have been sold so far and no complaint has been received with 
respect to safety issues in this time period. Biocompatibility, cytotoxicity, irritation and 
bioburden testing attested the sample collector to be safe to use (Reference 11.6, 
Biocompatibility Synopsis. 
Table 4. Anticipated adverse device effects and their respective mitigation for the Dräger test kit 
Possible 
adverse event 
Fre-
quency 
Severity 
Risk 
Mitigation 
Residual 
risk 
Contaminated 
sample collector 
Rare 
Catastrophic 
(depending on the 
pathogen) 
Infection and 
disease 
Special care is taken 
during production; IFU 
instructs on hygienic use 
None  
Investigator/ 
Operator contact 
with specimen 
(nasal secretions) 
of the patient 
during sampling/ 
Investigator 
contact with 
specimen-buffer 
mix 
Rare 
Catastrophic 
(depending on the 
pathogen) 
Infection and 
disease 
Operator wears PPE. 
Buffer is not harmful. 
Usual cleaning and 
disinfection procedures 
are sufficient. If 
preferred, a zip loc bag 
is provided for use 
during this step. 
None 
Nosebleed < 15 
min 
Rare 
Non-serious 
Injury, pain 
Observe the patient 
closely; if bleeding 
stops, continue the 
investigation. If it does 
not stop after 15 min, 
participant is transferred 
to emergency 
department for 
appropriate treatment 
and removed from the 
study.  See also lasting 
nosebleed below. 
None except 
potential time 
(< day) in the 
ER 
Lasting (> 15 min) 
nosebleed 
requiring 
intervention 
Rare 
Non-serious for 
most patients, 
serious for 
patients with 
bleeding disorder 
Blood loss 
Exclude patients with 
bleeding disorder; study 
staff awareness; 
Stop of participation in 
the study for appropriate 
treatment 
None except 
potential time 
(< day) in the 
ER 
 
Pharyngeal swabs are the sampling method for the comparator. As these specimens are not 
collected exclusively for this study, rather this study uses the results of the current default 
COVID-19 screening at the site, the procedure is not included in this study’s risk assessment.  
5.3 Criteria for interruption or early termination of the study: 
For the individual participant 
If nosebleed occurs in a participant, specimen collection is interrupted until the nosebleed 
stops. If it stops in less than 15 min, the investigation can continue with the second nostril. An 
Adverse Device Effect (ADE) is reported in the CRF. 
If the nosebleed does continue after 15 min of basic measures, the study investigation is 
stopped for this participant, and the participant is transferred to the emergency department to 
respond appropriately to stop the nosebleed. An Anticipated Serious Adverse Device Effect 
(ASADE) is reported in the CRF and the Sponsor is informed immediately. 
If the patient experiences severe pain, discomfort or wants to stop the procedure, the 
investigation is stopped for this patient and an AE or ADE is reported depending on the 
evaluation of the study physician. 

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Participants have the right to withdraw from the study at any time for any reason without penalty 
or prejudice. The investigator also has the right to withdraw patients from the study if he/she 
feels it is in the best interest of the patient or if the patient is uncooperative. 
For the study in general 
(1) The study stops immediately, if and when approval of the study/exemption of approval by 
the Authorities or the Ethics Committee is withdrawn or retracted. 
(2) The study is stopped early, if > 10% of participants experience lasting nosebleed (longer 
than 15 minutes) or unbearable pain. This assessment starts with the first 50 participants 
enrolled. See also 7. Monitoring below. 
(3) The Sponsor reserves the right to discontinue the study at any time in its entirety e.g. if, in 
the sponsor’s opinion, there is a significant safety concern, relevant technical problems 
with the device or an insufficient recruitment despite intensified efforts to screen potential 
participants. See also 7.4 Monitoring below. 
5.4 Documentation requirements 
All unexpected observations and/or adverse events must be reported and documented on the 
CRF by Operator and Principal Investigator (PI) (Tab. 5). 
The PI has the responsibility to document and explain any deviations or adverse events, 
actions taken, and notify the sponsor represented by a designated Project Lead (refer to 9.1 
Site and Sponsor Representatives for details). 
5.5 Notification requirements 
The table below describes the PI’s responsibilities regarding Sponsor notifications. 
Table 5. Event documentation and sponsor notification 
Event 
Document on CRF 
Notify via E-mail 
Notification Timing 
Deviation 
yes 
Sponsor’s Representative 
Within two weeks 
AE, ADE 
yes 
Sponsor’s Representative 
Within two weeks 
SAE, SADE 
yes 
Sponsor’s Representative 
Immediately; at the latest 
within 24 h 
ASADE, USADE 
yes 
Sponsor’s Representative 
Immediately; at the latest 
within 24 h 
 
The Sponsor informs the Competent Authority in case of SAEs via e-mail to 
MPSAE@bfarm.de. 
 
6. STATISTICAL AND ANALYTICAL CONSIDERATIONS 
All cases are included in the overall analysis and evaluation of the study and in the resulting 
report.  
In general, numbers of participants (eligible, enrolled, included in analysis), Dräger test and 
PCR results, invalid tests, dropouts at every level, deviations, AEs etc. are recorded, monitored 
throughout the study, and reported in the final study report. Performance data is presented in 
the context of these counts. Only cases for which both a valid Dräger test and a valid PCR 
result are available are included in the determination of performance parameters such as 
sensitivity and specificity (see below). In addition, the following information is required for a 
case to be included, i.e. a case is excluded should the following information not be 
documented:  

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• 
Participant ID 
• 
Participant provided written informed consent. 
• 
Information regarding any pain sensation 
• 
Information regarding nosebleed 
• 
Information regarding adverse event (on the level of yes or no) 
6.1 Case number estimation 
For the case number estimation for the primary endpoint the following assumptions are made: 
Sensitivity: 
Lindner et al. (in press) collected samples from the anterior nose and observed 27 of 29 SARS-
CoV-2 PCR-positive samples (> 106 copies/mL) to also be rapid antigen test-positive (93.1% 
agreement). The case number estimation for the Dräger Antigen Test SARS-CoV-2 is based 
on a more conservative expectation of 90% sensitivity. This assumption is based on 
preliminary performance data of the test under evaluation and the threshold for PCR set to 106 
copies/mL (refer to 6.2 for details). 
The half width of the confidence interval (W) is pre-determined at 5%, as 90% ± 5% provides 
sufficient test reliability for a daily application in the clinical setting. A test sensitivity of 85% 
would still meet the PEI criterion for antigen tests (sensitivity > 80%; PEI, 2021). 
Specificity: 
Lindner et al. (in press) observed a rapid antigen test specificity of 99.6% (95% CL, CI 97.8-
100.0%) in anterior nasal swabs. As a result, the investigational product is expected to be 99% 
specific. For diagnostic applications, a device should deliver a specificity of 99% with a 
precision of ± 1% in order to be of service, e.g. in the screening of symptomatic patient at times 
of high incidence. It also needs to be taken into account that the intended use of the 
investigational product is for screening; ultimate confirmation of the preliminary result remains 
for more sensitive PCR testing. 
Separate calculations for case numbers for sensitivity and specificity of the test are performed 
following the approach by Hajian-Tilaki (2014). The following formulae are used: 
𝑁𝑁(𝑆𝑆𝑆𝑆) = 𝑧𝑧2 × (𝑆𝑆𝑆𝑆(1 −𝑆𝑆𝑆𝑆))
𝑊𝑊2 × 𝑃𝑃
 
𝑁𝑁(𝑆𝑆𝑆𝑆) = 𝑧𝑧2 × (𝑆𝑆𝑆𝑆(1 −𝑆𝑆𝑆𝑆))
𝑊𝑊2 × (1 −𝑃𝑃) 
with 
• 
N = Case Number 
• 
SN = Sensitivity 
• 
SP = Specificity 
• 
z = z-value corresponding to a confidence level of 95%  
• 
P = Prevalence of disease in the test population. Prevalence is assumed to be at least 
20% based on current data from the prospective study sites indicating an actual 
prevalence among all participants tested for SARS-CoV-2 of 25%. 
• 
W = maximum marginal error (half width of 95% confidence interval) for sensitivity and 
specificity, respectively 
The resulting case number estimation for sensitivity evaluation of the investigational product is 
691. Assuming a 5% dropout rate, 726 participants have to be enrolled. For specificity 
evaluation, 500 participants (allowing for up to 5% dropouts) need to be enrolled. Since the 
prevalence of PCR-negative participants is assumed to be at 80%, more test negative cases 
(580) are expected to be enrolled in the study for the determination of sensitivity alone. As a 

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result, the cases needed for specificity assessment are covered by the case number estimated 
for sensitivity assessment. In explicit, 726 participants are enrolled to sufficiently power overall 
sensitivity and specificity evaluation of the test product. 
Based on the current testing strategy (Federal Ministry of Health, Germany, Dec. 16, 2020) 
and according to communications with the study site (Dec. 2020), more symptomatic than 
asymptomatic persons present themselves for PCR testing at the site. In order to ensure a 
minimum of 100 asymptomatic cases to be included in the performance evaluation of the 
investigational product (PEI, 2021), an additional 105 participants are added to the total case 
number. This allows for a 5% dropout rate among asymptomatic participants, and it ensures 
performance evaluation of the test for asymptomatic people even if most or all cases enrolled 
for overall sensitivity and specificity evaluation belong to the symptomatic group.  
As a result, the total case number estimate for this study adds up to 726 + 105 = 831. 
6.2 RT-PCR, cycle thresholds and viral concentration 
PCR as the gold standard for SARS-CoV-2 detection provides the benchmark for this 
performance evaluation study, i.e. a true representation of the actual SARS-CoV-2 state of the 
participant (positive or negative). Following RKI reasoning (RKI, 2020a), RT-PCR results are 
not only scored as absolute results of positive or negative, but also in the context of detected 
viral load per sample within the PCR positives. The RKI provides a threshold of 106 copies/mL 
beyond which the viral culturability potential seems neglectable (cell culture experiments as in 
vitro test to indicate infectiousness) (RKI, 2020b). Based on the PCR assay and cycler 
combination used for sample analysis, this viral concentration translates into a system-specific 
cycle threshold (ct) value for each sample, when the system is calibrated with reference 
standards (RKI, 2020a). This study uses the system-specific ct value corresponding to 106 
RNA copies/mL to sort the PCR positives into either above or below this threshold.  
Sensitivity and specificity of the Dräger test are determined based on true- and false-positive 
as well as true- and false-negative counts determined by comparing the Dräger test results to 
PCR results scored as follows:  
• 
PCR-negative: negative PCR and positive PCR with viral concentration < 106 
copies/mL, and  
• 
PCR-positive: positive PCR with viral concentration ≥ 106 copies/mL.  
Based on RKI information (RKI, 2020a), this ct cut-off value is expected to be at approximately 
30 cycles and is determined by the diagnostic laboratory analyzing the PCR samples for this 
study. 
6.3 Assessment of primary objective 
Dräger test and PCR results for all participants are recorded. All valid data pairs (valid Dräger 
test result, valid PCR result, complete records as defined on pp. 13) from the symptomatic 
group feed into sensitivity and specificity evaluation of the Dräger test. A contingency table is 
used to present sensitivity, specificity, and associated confidence intervals (CI at a confidence 
level of 95%).  
Table 7. Assessment of results. 
Dräger Antigen Test  
SARS-CoV-2 result 
Reference method RT-PCR result 
Positive 
Negative 
Positive 
True positive (TP)  
False positive (FP)  
Negative 
False negative (FN)  
True negative (TN)  
 

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Key parameters to be determined: 
Sensitivity = 
TP
TP + FN × 100 
Specificity = 
TN
FP + TN × 100 
6.4 Assessment of secondary objectives 
Secondary endpoints are of explorative nature and descriptive statistics are used for evaluation 
(mean, median, minimum, maximum, frequencies, standard deviation, 95% CL confidence 
limits). 
All valid data pairs (valid Dräger test result, valid PCR result, complete records) feed into 
sensitivity and specificity evaluation of the Dräger test. Sensitivity and specificity including 
lower and upper confidence limits for the test under evaluation are calculated for different cut-
offs of the ct value of the PCR test in addition to the predefined ct value for the primary endpoint 
(currently defined by a viral concentration of 106 RNA copies/mL and to be calibrated to ct). 
Prerequisite for inclusion in this explorative evaluation is that the case record is not only 
complete as defined above, but also provides the information required to allow sorting into 
groups according to e.g. ct values. 
Sensitivity and specificity including lower and upper confidence limits for the test under 
evaluation are calculated for participants grouped by  
• 
ct value (as described above), 
• 
time since symptoms onset (using the general cut-off ct value of the PCR test used for 
the primary endpoint evaluation; on symptomatic group only), 
• 
symptom status (symptomatic vs asymptomatic). 
In addition to sensitivity and specificity centric explorative evaluation, the frequency of lasting 
nosebleeds or unbearable pain in participants is tracked. The primary information is captured 
in the CRF. Once the 50 participants have been enrolled the fraction of participants reporting 
such experiences is determined daily.  
 
7. DATA QUALITY ASSURANCE 
7.1 Training of study staff 
Staff receives hands-on training for the Dräger Antigen Test for SARS-CoV-2 prior to collecting 
study specimens. This training is documented on the Operator Training Form (see Appendices 
below).  
Red-green visual impairments disqualify staff as operators for this trial. 
7.2 Case Report Form (CRF) 
For each participant enrolled in the study, a case report form collects all study-relevant 
information. The corresponding patient file is archived at the study site. These two records are 
linked only by participant ID, as the clear name of the patient is not recorded on the case report 
form. 
The operator documents the respective steps of the procedure and other case information in 
the CRF. Operator and Principal Investigator confirm these records are complete. Corrections 
are made such that the original entry stays legible. The new entry is dated and signed, too. 

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7.3 Archiving/Record retention 
Data generated are documented, recorded, reported and archived in conformity with the CPSP 
and national standards. Records (Investigator Site File and Trial Master File) are retained for 
at least 10 years after completion or suspension of the trial. The Sponsor keeps a part of the 
documentation relating to the trial for as long as the product is authorized. 
7.4 Monitoring 
Monitor 
The Sponsor defines a representative as Monitor of the Study prior to study start. The Monitor 
is the primary contact for the clinical study site and all questions related to the study. In addition, 
the Monitor checks in with the site and may request information or documentation pertaining 
to the study as she/he sees fit (prior to and during the trial).  
Selected original documentation and database entries are compared by the Sponsor as a 
cross-check. 
Sponsor 
The Sponsor receives regular updates from the site on study progress, adverse events and 
preliminary data. This information is used to determine the fraction of all participants reporting 
pain or/and nosebleed as a result of specimen collection (or the frequency of pain and 
nosebleeds). When reaching 50 enrolled participants, the counts are tracked daily using the 
PI’s daily updates and any potential Adverse Event notifications. Should at any point of time > 
10% of participants report unbearable pain or lasting nosebleed the study stops.  
The Sponsor’s Decision Board - in its role as the complaint handling entity for clinical studies 
- evaluates, e.g. every SAE that may occur during the study and defines next steps.  
At half-way point of the study the Sponsor’s Decision Board reviews an overview of study-
related information, e.g. device performance, AE summary, enrollment. The goal is to evaluate 
overall study progress and current safety and performance status of the investigational 
product. The board may take the decision to interrupt the study or terminate it early. Refer to 
5.3 for selected scenarios.  
7.5 Audits 
Audits can be scheduled as needed. Currently, no inspections are planned during the course 
of this study. 
7.6 Privacy 
Data collected during this study includes personal information. Patient-related information 
including the clear name is managed, stored and archived only at the study site. The Sponsor 
only receives study-relevant information as collected in the CRF (which is identified by 
participant ID, not the patient name, i.e. pseudonymized).  
Only dedicated study staff enter into and access study data records, i.e. access is restricted to 
authorized personnel, all of which abide current legislation on privacy. 
Should a study participant decide to retract from this study, any existing entries would be 
deleted. Any personal information associated with this study would be destroyed after up to 
ten years, unless defined otherwise by legal or in-house requirements.  
 
8. ETHICS AND REGULATORY REQUIREMENTS 
All parties involved in this trial execute the study according to applicable laws and regulations 
and under consideration of the WMA Declaration of Helsinki.  

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The Ethics Committee of the site reviews the study protocol and accompanying documents. 
Suggestions by the Ethics Committee are taken into account such that the study can be 
approved and conducted. The study cannot be conducted should the Ethics Committee 
disapprove of parts of or the whole study protocol. The committee is also informed about any 
safety issues that might occur during the study as well as the closing of the study. 
 
9. STUDY TEAM 
9.1 Site and sponsor representatives 
Principal Investigator 
Dr. med. Daniel Zickler 
Charité – Universitätsmedizin Berlin 
Augustenburger Platz 1 
13353 Berlin 
Tel.: +49 30 450 514 002 
E-Mail: daniel.zickler@charite.de 
Fax: +49 30 450 514 902 
 
Co-Investigator 
Prof. Dr. Klemens Budde 
Charité – Universitätsmedizin Berlin 
Charitéplatz 1 
10117 Berlin 
Tel.: +49 30 450 514 002 
E-Mail: klemens.budde@charite.de 
Fax: +49 30 450 514 902 
 
Sponsor’s representative  
Dr. Rainer Polzius 
Drägerwerk AG & Co KGaA 
Moislinger Allee 53-55 
23542 Lübeck 
Tel.: +49 451 882 4429 
E-Mail: Rainer.Polzius@draeger.com 
 
Clinical and scientific experience of principal investigator(s) is demonstrated in the attached 
CVs and/or certificates. 
9.2 Funding 
The study is funded by Dräger. 
 
10. 
PUBLICATION  
A Clinical Performance Study Report summarizes the events and outcome of the study. Key 
results are included in the Instructions for Use to be provided to kit users upon purchase or 
request after product release. The PI may publish the outcome of this study as a scientific 
publication after product release. Details are addressed in a separate contract. 
 
 

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11. 
REFERENCES 
11.1 Instructions for Use Dräger Antigen Test SARS-CoV-2 
11.2 Risk Management Report Antigen Test SARS-CoV-2 
11.3 Clinical Study Risk Evaluation 
11.4 ISO 20916:2019 
11.5 Report on Usability of Sampling Unit 
11.6 Biocompatibility Synopsis 
11.7 Instruction for Use Roche Cobas SARS-CoV-2 
11.8 Bibliography of cited journal articles and websites: 
van Beek, J., Igloi, Z., Boelsums, T., Fanoy, E., Gotz, H., Molenkamp, R., van Kampen, J., 
GeurtsvanKessel, C., van der Eijk, A., van de Vijver, D., & Koopmans, M. (preprint). From more 
testing to smart testing: data-guided SARS-CoV-2 testing choices [Preprint]. Infectious 
Diseases (except HIV/AIDS). https://doi.org/10.1101/2020.10.13.20211524 
Corman, V. M., Landt, O., Kaiser, M., Molenkamp, R., Meijer, A., Chu, D. K., Bleicker, T., 
Brünink, S., Schneider, J., Schmidt, M. L., Mulders, D. G., Haagmans, B. L., van der Veer, B., 
van den Brink, S., Wijsman, L., Goderski, G., Romette, J.-L., Ellis, J., Zambon, M., … Drosten, 
C. (2020). Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. 
Eurosurveillance, 25(3). https://doi.org/10.2807/1560-7917.ES.2020.25.3.2000045 
Hajian-Tilaki, K. (2014). Sample size estimation in diagnostic test studies of biomedical 
informatics. 
Journal 
of 
Biomedical 
Informatics, 
48, 
193–204. 
https://doi.org/10.1016/j.jbi.2014.02.013 
Hasöksüz, M., Kiliç, S., & Saraç, F. (2020). Coronaviruses and SARS-COV-2. Turkish Journal 
of Medical Sciences, 50(SI-1), 549–556. https://doi.org/10.3906/sag-2004-127 
Lindner A. K., Nikolai O., Kausch F., Wintel M., Hommes F., Gertler M., Krüger L. J., Gaeddert 
M., Tobian F., Lainati F., Köppel L., Seybold J., Corman V. M., Drosten C., Hofmann J., Sacks 
J. A., Mockenhaupt F. P., Denkinger C. M. (in press) Head-to-head comparison of SARS-CoV-
2 antigen-detecting rapid test with self-collected anterior nasal swab versus professional-
collected 
nasopharyngeal 
swab. 
Eur 
Respir 
J. 
2020 
Dec 
10:2003961. 
doi: 
10.1183/13993003.03961-2020 [Epub ahead of print]. PMID: 33303544; PMCID: 
PMC7736752. 
Masters, P. S. (2006). The Molecular Biology of Coronaviruses. Advances in Virus Research, 
66, 193–292. https://doi.org/10.1016/S0065-3527(06)66005-3 
Matheeussen, V., Corman, V. M., Donoso Mantke, O., McCulloch, E., Lammens, C., 
Goossens, H., Niemeyer, D., Wallace, P. S., Klapper, P., Niesters, H. G., Drosten, C., Ieven, 
M., & on behalf of the RECOVER project and collaborating networks. (2020). International 
external quality assessment for SARS-CoV-2 molecular detection and survey on clinical 
laboratory preparedness during the COVID-19 pandemic, April/May 2020. Eurosurveillance, 
25(27). https://doi.org/10.2807/1560-7917.ES.2020.25.27.2001223 
Paul Ehrlich Institute. (2021). Mindestkriterien für SARS-CoV-2 Antigentests im Sinne von § 
1 Abs. 1 Satz 1 TestVO: Antigenschnelltests. SARS-CoV-2-Testsysteme. 
https://www.pei.de/DE/newsroom/dossier/coronavirus/testsysteme.html, Jan. 15, 2021 
Robert Koch Institute (2020a). Hinweise zur Testung von Patienten auf Infektion mit dem 
neuartigen Coronavirus SARS-CoV-2.  
https://www.rki.de/DE/Content/InfAZ/N/Neuartiges_Coronavirus/Vorl_Testung_nCoV.html; 
status of Dec. 23, 2020 
Robert Koch Institute (2020b). COVID-19: Entlassungskriterien aus der Isolierung. 
https://doi.org/10.25646/6957.4, status of Dec. 29, 2020 

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Weiss, S. R., & Leibowitz, J. L. (2011). Coronavirus Pathogenesis. Advances in Virus 
Research, 81, 85–164. https://doi.org/10.1016/B978-0-12-385885-6.00009-2 
 
 

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