Dräger COVID-19 Antigen Test Clinical Performance Study

Dräger Antigen Test SARS-CoV-2 Clinical Performance Study

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04698993

Enrollment

388

Registered

2021-01-07

Start date

2021-02-12

Completion date

2021-03-22

Last updated

2021-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

antigen test

Brief summary

The study is designed to demonstrate suitability of the Dräger Antigen Test for SARS-CoV-2 detection in clinical nasal specimens. Real-time polymerase chain reaction (RT-PCR) on specimens collected by pharyngeal swabs serves as a reference method.

Detailed description

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. The study is designed to demonstrate suitability of the Dräger Antigen Test for SARS-CoV-2 detection in clinical nasal specimens. Real-time polymerase chain reaction (RT-PCR) on specimens collected by pharyngeal swabs serves as a reference method. The goal of the study is to compare Dräger test results to the corresponding PCR data for overall sensitivity and specificity. Specimens are collected from patients showing COVID-19 symptoms as well as asymptomatic participants. Participants are recruited across all genders and eligible age groups. 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 Dräger test result is read after 15 min to 20 min.

Interventions

DIAGNOSTIC_TESTDräger Antigen Test SARS-CoV-2

Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Participants must require SARS-CoV-2 testing for the following reasons: * 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 * Known or suspected exposure to SARS-CoV-2 (contact persons etc.), or * Member of a group of high risk of exposure such as healthcare workers etc., or * 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.

Exclusion criteria

* Patients younger than 18 years old are excluded from the study. * Pregnant or breastfeeding patients are excluded from the study. * Patients unable to provide written informed consent are excluded. * Patients with bleeding disorder are excluded from the study as a precaution. * 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 14 days prior to testing. * Asymptomatic participants are excluded, if they experienced any symptoms in the 14 days prior to testing.

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity	Through study completion, an average of 1 1/2 month	Sensitivity (true positive rate) of antigen test in symptomatic participants compared with reference standard PCR test (at a threshold of \>=10\^6 RNA copies/ml for positive PCR results)
Specificity	Through study completion, an average of 1 1/2 month	Specificity (true negative rate) of antigen test in symptomatic participants compared with reference standard PCR test (at a threshold of \>=10\^6 RNA copies/ml for positive PCR results)

Secondary

Measure	Time frame	Description
Sensitivity in Relation to the Cycle Threshold Value of the Reference RT-PCR (in the Symptomatic Group)	Through study completion, an average of 1 1/2 month	Description of relationship between cycle threshold value of the reference RT-PCR and Dräger test performance. Presented is the sensitivity(true positive rate) in the symptomatic group at a cycle threshold of \<22
Sensitivity in Relation to the Time Since Symptom Onset (in the Symptomatic Group)	Through study completion, an average of 1 1/2 month	Description of relationship between days since symptom onset and Dräger test performance. Presented is the sensitivity(true positive rate) in the symptomatic group at days since symptom onset \<5
Specificity in Asymptomatic Participants	Through study completion, an average of 1 1/2 month	Specificity of the antigen test in at least 100 asymptomatic participants
Frequency of Nosebleed or Unbearable Pain During or Immediately After Specimen Collection	Through study completion, an average of 1 1/2 month	Record of occurrence of lasting nosebleed or unbearable pain during or immediately after specimen collection

Countries

Germany

Participant flow

Participants by arm

Arm	Count
Symptomatic Collection of specimens from symptomatic COVID-19 positive participants Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test	275
Asymptomatic Collection of specimens from asymptomatic participants who had known or suspected exposure to SARS-CoV-2 Dräger Antigen Test SARS-CoV-2: Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test	113
Total	388

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	incomplete documentation of kit assessment prior to testing	1	0
Overall Study	PCR results not accessible	2	7

Baseline characteristics

Characteristic	Asymptomatic	Total	Symptomatic
Age, Continuous	32.5 years	34.0 years	34.6 years
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment Germany	113 participants	388 participants	275 participants
Sex: Female, Male Female	66 Participants	211 Participants	145 Participants
Sex: Female, Male Male	47 Participants	177 Participants	130 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 275	0 / 113
other Total, other adverse events	0 / 275	0 / 113
serious Total, serious adverse events	0 / 275	0 / 113

Outcome results

Primary

Sensitivity

Sensitivity (true positive rate) of antigen test in symptomatic participants compared with reference standard PCR test (at a threshold of \>=10\^6 RNA copies/ml for positive PCR results)