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TEST CODE

3092

CPT CODE

86769

SPECIMEN PREPARATION

• Separate serum or plasma from cells within 2 hours of collection. Transfer 2 mL of serum or plasma to a labeled aliquot transport tube.

SPECIMEN TRANSPORT

• Specimens can be sent room temperature, refrigerated, or frozen.

SPECIMEN TYPE

SERUM (PREFERRED COLLECTION)

• Serum separator tube or SST (tiger-top tube)
• Serum aliquot from a red-top no gel (red-top tube)

PLASMA (ALTERNATIVE COLLECTION)

• Plasma aliquot from an EDTA tube (purple-top tube)
• Plasma aliquot from a Li Hep tube (mint green or green-top tube)

Requested Volume: 2 mL

• Minimum Volume: 0.5 mL (may not allow for repeat testing)

COLLECTION

1. Complete the test requisition form (provided separately).
2. Label tube with patient’s name and date of birth. Failure to provide two patient identifiers will prevent or delay testing.
3. Follow collection protocol based on sample type in kit.
4. Put the sample in the specimen bag with the absorbent sleeve and seal the bag.
5. Insert completed test requisition form into outer pocket of specimen bag.

SPECIMEN STABILITY

• Room temperature — 3 days
• Refrigerated — 7 days
• Frozen — 28 days (only 1 freeze/thaw allowed)

REJECTION CRITERIA

• Specimen types not previously specified will be rejected
• Minimum volume: 0.8 mL serum or plasma

TEST SETUP

Monday – Saturday (days)

TURN AROUND TIME

24 – 48 hours

METHODOLOGY

About Elecsys Anti-SARS-CoV-2 serology test:

Elecsys® Anti-SARS-CoV-2 is an immunoassay for the in-vitro qualitative detection of antibodies (including IgG) to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human serum and plasma. Through a blood sample, the test, which is based on an in-solution double-antigen sandwich format, can detect antibodies to the new coronavirus causing COVID-19, which could signal whether a person has already been infected and potentially developed immunity to the virus. Based on the measurement of a total of 5,272 samples, the Elecsys® Anti-SARS-CoV-2 assay has 99.81% specificity and shows no cross-reactivity to the four human coronaviruses causing common cold. This means it can lower the chance of false positives due to the detection of similar antibodies that may be present in an individual, but are specific for coronaviruses other than SARS-CoV-2. Elecsys® Anti-SARS-CoV-2 detected antibodies with 100% sensitivity in samples taken 14 days after a PCR-confirmed infection. The importance of specificity and sensitivity of a particular test will be dependent on its purpose and disease prevalence within a given population.