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Test Code LAB20555 GONORRHOEAE PCR (COVLAB CEPHEID)

Department

Immunology

Collection Requirements

Genital Swab:

For specific instructions on how to collect vaginal or endocervical samples, please refer to the link(s) below showing printable step by step instructions. The documents can be found on the “Lab Forms and Resources” tab on the Laboratory page in COVNET.

Cepheid-Clinician-Collected-Vaginal-Swab-Specimen-Collection

Cepheid-Patient-Collected-Vaginal-Swab-Specimen-Collection

Cepheid-Endocervical-Specimen-Collection


Note: Self collected vaginal swab specimens must be collected in a clinical care setting with health care providers available.

Urine:


For specific instructions on how to collect urine samples for testing, please refer to the link(s) below showing printable step by step instructions. The documents can be found on the “Lab Forms and Resources” tab on the Laboratory page in COVNET.

Cepheid-Urine-Specimen-Collection-Guide

Throat and Rectum:


For specific instructions on how to collect Rectum or Pharynx samples for testing, please refer to the link(s) below showing printable step by step instructions. The documents can be found on the "Lab Forms and Resources" tab on the Laboratory page in COVNET.

Primary Collection Container

Xpert Media

Alternate Collection Container

Sterile Urine Cup for urine only.

Transport

Swab or Urine collection Refrigerated

Preferred Transport Temperature

Refrigerrated

Processing

If urine is received in a sterile cup, transfer to Cepheid Xpert Urine Specimen Collection Kit using pipette provided in collection kit. (Only if within stability requirements)

Stability

Genital swab collected in Cepheid Xpert Swab Specimen Collection Kit: 60 days refrigerated or Ambient

Urine collected in Cepheid Xpert Urine Specimen Collection Kit: 45 days Refrigerated Urine in steril cup (unpreserved): 8 days Refrigerated

Reference Range

Negative

Methodology

Cepheid PCR (RT-PCR)

Performed

Sunday-Saturday

Reported

As completed

CPT Codes

87491

Unacceptable Conditions

Urine collections not filled to minimum fill line.

Samples sent outside of conditions listed in stability section.

Samples sent in collection container/devices not listed.

Avoid excessive stool when collecting rectal specimens.

Minimum Testing Volume

Urine:
Up to line on collection kit.
Swab:
N/A

Additional Information

• Swab samples collected in Cepheid Xpert Swab Specimen Collection Kit: 60 days refrigerated or Ambient

• First catch female urine specimen must be transferred to the Xpert Urine Transport Reagent tube within 24 hours of primary collection if shipped and/or stored at room temperature.

• First catch male urine specimen must be transferred to the Xpert Urine Transport Reagent tube within 3 days of primary collection if shipped and/or stored at room temperature.

• First catch male and female urine specimen NOT transferred to the Xpert Urine Transport Reagent tube (unpreserved urine specimen) can be shipped and/or stored for up to 8 days at 4 °C.

• First catch female urine specimen that is transferred to the Xpert Urine Transport Reagent tube (preserved female urine specimen) can be shipped and/or stored up to 45 days at 2 °C to 15 °C, or up to 3 days at 2 °C to 30 °C before testing.

• First catch male urine specimen that is transferred to the Xpert Urine Transport Reagent tube (preserved male urine specimen) can be shipped and/or stored up to 45 days at 2 °C to 30 °C before testing.