Ezplex SARS-CoV-2 G

FDA Emergency Use Authorization (EUA)

CE IVD

Korean MFDS (Ministry of Food and Drug Safety)

The Ezplex SARS-CoV-2 G Kit is real-time RT-PCR in vitro diagnostic test intended for the qualitative detection of nucleic acid from SARS-CoV-2 (RdRp and N genes) in individuals suspected of COVID-19 by their healthcare provider  (nasopharyngeal and oropharyngeal swabs and sputum).
The test can be quickly and accurately completed through PCR with extracted RNA, and the results can be conveniently viewed using Genetree Viewer assay software.
• For in vitro diagnostic use. For use under an Emergency Use Authorization (EUA) only.
• This product has not been FDA cleared or approved; but has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
• This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.

• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Features and Benefits

Fast Results

Produces test results within 2.5 hours post extraction.


Real-time PCR

Detection and identification of target genes (RdRP, N) specific for COVID-19 in a single tube.


Specimen Pooling Capability

Five times as many tests can be conducted within the same time period. (FDA EUA and CE IVD)


Sensitivity

Reference material was repeatedly tested through serial dilution to show high analytical sensitivity. FDA SARS-CoV-2 Reference Panel detection limit of 1200 NDU*/mL.

•NAAT Detectable Units/mL

Accessibility

Test results can be easily analyzed with dedicated user-friendly Genetree Viewer software.


Product Specifications

Sample Type
- Nasopharyngeal and Oropharyngeal Swabs
- Sputum

Extraction Platforms
- QIAamp DSP® Virus Spin Kit (Qiagen GmbH)

- Nextractor NX-48 (Genolution) - CE IVD only


PCR Platform

- CFX96 Dx Real-Time PCR Instrument (Bio-Rad)
- ABI 7500 Real-Time PCR Instrument (ThermoFisher Scientific)

Targets
- COVID-19 (N gene)
- COVID-19 (RdRp gene)

Intended Use

The Ezplex SARS-CoV-2 G Kit is a real-time RT-PCR in vitro diagnostic test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal swabs, and sputum specimens collected from individuals suspected of COVID-19 by their healthcare provider. Testing in the U.S. is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
This test is also for the qualitative detection of nucleic acid from the SARS-CoV-2 in pooled specimens containing up to five individual nasopharyngeal or oropharyngeal swabs where each specimen is collected by a healthcare provider using individual vials containing transport media from individuals suspected of COVID-19 by their health care provider. Negative results from pooled testing should not be treated as definitive. If a patient’s clinical signs and symptoms are inconsistent with a negative result or if results are necessary for patient management, then the patient should be considered for individual testing. Specimens included in pools with a positive, inconclusive, or invalid result must be tested individually prior to reporting a result. Specimens with low viral loads may not be detected in specimen pools due to the decreased sensitivity of pooled testing.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient 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 results to the appropriate public health authorities.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The Ezplex SARS-CoV-2 G Kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Ezplex SARS-CoV-2 G Kit is only for use in the United States under the Food and Drug Administration’s Emergency Use Authorization.

Kit components 

100 tests

NO.
Kit Component
Volume
Lid Remarks
1RQ Mixture
1 vial, 1,000uL
RQ
2
P+P
1 vial, 500uL
P+P
3
Positive Control
1 vial, 50uL
PC
4
Negative Control
1 vial, 50uL
NC
5
Internal Control
1 vial, 20uL
IC

Storage

Kit should be stored under -20℃ with opened/unopened status. Shelf life is 12 months from date of manufacture.

Work Flow