Category

Molecular Genetic Pathology & Cytogenetics

Sub Category

Infectious Disease

Synonym/Aliases

Covid-19 Rt-pcr

Abbreviations

Covid PCR

Type

Individual Test

Results

RESULTS READY WITHIN 24 HOURS

Method

REAL TIME REVERSE TRANSCRIPTION PCR (RT-PCR) FOR DETECTION OF SARS-CoV-2 NUCLEIC ACID (RNA).

Temp

REFRIGERATED, 2-8ºC (48-72 HOURS); FROZEN (>72 HOURS)

Setup

DAILY

Components Parameters

- N/A

PRE-ANALYTIC CONSIDERATIONS

Test Ordering Instructions

FILL OUT TEST REQUEST FORM FULLY & LEGIBLY. SARS-CoV-2 CASE INVESTIGATION FORM WILL NEED TO BE FILLED OUT IN ENTIRETY TO FULFILL MOH/ NATIONAL REPORTING REQUIREMENTS.

Patient preparation

- N/A

Sample type

NASOPHARYNGEAL (NP) &/ OR OROPHARYNGEAL (OP) SWAB COLLECTED USING DRAYON, RAYON OR POLYESTER FIBRE SWABS, PLACED IN VIRAL TRANSPORT MEDIA (VTM) & WELL CAPPED. SAMPLES MUST BE LABELED WITH PATIENT NAME, OTHER UNIQUE IDENTIFIER, SAMPLE TYPE(S) & COLLECTION DATE. THEY MUST BE ACCOMPANIED BY A LAB REQUISITION AND A LEGIBLE AND FULLY FILLED COVID-19 CASE INVESTIGATION FORM. SAMPLES ARE TRIPLE PACKAGED AND IMMEDIATELY DELIVERED/ TRANSPORTED WITH FROZEN GEL PACKS.

Container/ preservative

NP &/ OR OP SWAB IN VIRAL TRANSPORT MEDIUM (VTM).

Sample volume

- N/A

Rejection criteria

LABELING ISSUE (UNLABELED/ MISLABELED); MISSING REQUEST FORM; MISMATCH BETWEEN REQUEST FORM & SAMPLE DETAILS; MISSING AGE/ GENDER; WRONG SAMPLE TYPE; INSUFFICIENT SAMPLE.

Other Instructions

CALCIUM AGINATE, COTTON SWABS OR SWABS WITH WOODEN STICKS CAN INHIBIT PCR RESULTING IN FALSE NEGATIVE RESULTS. SAMPLES COLLECTED USING THESE WILL NOT BE ACCEPTED/ PROCESSED. SAMPLES WITHOUT A COMPLETED COVID-19 CASE INVESTIGATION FORM WILL BE PUT ON HOLD AND NOT PROCESSED. INFORMATION CAPTURED ON THE FORM IS MANDATORY WHEN REPORTING TO A) THE NATIONAL COMPILATION CENTRE IN ACCORDANCE WITH CAP 242 (PUBLIC HEALTH) REGULATIONS SINCE COVID-19 IS A NOTIFIABLE ILLNESS B) THE panaBIOS TRUSTED TRAVEL DATABASE WHICH GENERATES TRUSTED TRAVEL (TT) CODES & CERTIFICATES FOR INTERNATIONAL TRAVELERS.

Reference intervals

INTERPRETIVE DATA IS PROVIDED ON THE REPORT.

Clinical Utility

COVID 19 DIAGNOSIS, SCREENING

Test Limitations / Confounders

FALSE NEGATIVE RESULTS MAY ARISE E.G. IF: 1) YOU HAVE BEEN TESTED TOO EARLY IN THE ILLNESS. A REPEAT TEST LATER MAY BE POSITIVE. 2) YOU HAVE BEEN TESTED TOO LATE IN THE ILLNESS (PARTIAL RECOVERY PHASE) 3) THE SAMPLE COLLECTION WAS INADEQUATE THEREFORE THERE IS AN INADEQUATE AMOUNT OF TESTING MATERIAL. 4) THERE ARE MUTATIONS IN TARGET GENES. 5) SAMPLES ARE NOT PROPERLY TRANSPORTED OR STORED. FALSE POSITIVE RESULTS (DETECTION OF SARS-COV-2 WHEN ONE DOES NOT HAVE COVID-19) MAY ARISE IF THERE IS CONTAMINATION DURING SAMPLE COLLECTION – SWAB TOUCHES A CONTAMINATED SURFACE.