ePLEX Respiratory Pathogen Panel 2, by RT PCR

Test Code

Lab1994

Alias/See Also

RP Panel

CPT Codes
0225U

Preferred Specimen

Nasopharyngeal Swab

Minimum Volume

3 mL UTM

Other Acceptable Specimens

None

Instructions

Collection Instructions:

1. Open the UTM Sample collection pouch and remove the tube and swab.
2. Collect the sample from patient.
3. Unscrew and remove the cap from UTM tube making sure not to spill the medium.
4. Insert the swab into the tube breaking the swab shaft where it scored holding the tube away from your face.
5. Discard the broken handle part of the swab shaft into biohazard waste container.
6. Replace cap on the tube and secure tightly.

Transport Container

3 mL Universal Transport Medium (UTM)

Transport Temperature

Room Temperature (15-30 ^OC): up to 12 hours
Refrigerated (2- 8 ^OC) up to 10 days
Freeze at -20° or below: 12 Months

Specimen Stability

Room Temperature (15-30 ^OC): up to 12 hours
Refrigerated (2- 8 ^OC) up to 10 days
Freeze at -20° or below: 12 Months

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Specimen Delay in Transit
Specimen Leaked transit
Improper Specimen Collection
Specimen Missed Labeled

Methodology
GenMark ePlex RT-PCR (Real-time polymerase chain reaction)

Setup Schedule

Daily, all shifts

Reference Range

Not detected

Clinical Significance

Clinical Significance: Respiratory Pathogen Panel 2 (ePlex RP2 Panel) is a multiplexed nucleic acid in vitro diagnostic test intended for use on the ePlex Instrument for the simultaneous qualitative detection and differentiation of nucleic acids from multiple respiratory viral and bacterial organisms, including nucleic acid from Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), in nasopharyngeal swabs (NPS) eluted in viral transport media obtained from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and the targeted respiratory viral and bacterial organisms can be similar.

Pathogen Targets:
Adenovirus                                                         Parainfluenza Virus 1
Coronavirus (29E, HKU1, NL63, OC43)            Parainfluenza Virus 2
SARS-CoV-2                                                      Parainfluenza Virus 3
Human Metapneumovirus                                  Parainfluenza Virus 4
Human Rhinovirus/Enterovirus                         Respiratory Syncytial Virus A
Influenza A                                                         Respiratory Syncytial Virus B
Influenza A H1                                                   Bacterial Target:
Influenza A H1-2009                                          Chlamydia pneumoniae
Influenza A H3                                                   Mycoplasma pneumoniae
Influenza B

Performing Laboratory
Meritus Molecular Diagnostics - Microbiology

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.