FAQ: How are results interpreted in the Luna SARS-CoV-2 RT-qPCR Multiplex Assay Kit?

Sample

2019-nCoV N1 (HEX)

2019-nCoV N2 (FAM)

Internal Control (Cy5)

Interpretation

Positive Control

Cq<27

Cq<27

ND

QC passed

Negative Control

ND

ND

ND

QC passed

Test Sample

ND

ND

ND

Invalid Test
(Internal Control Failure)

Cq<40

ND

Cq<40

Inconclusive - Retest

ND

Cq<40

Cq<40

Inconclusive - Retest

Cq<40

Cq<40

Cq<35 or ND*

Positive

ND (or Cq>40)

ND (or Cq>40)

Cq<35

Negative

* It is important to note that when a test sample contains viral RNA yet only a few or no somatic cells, it is possible to observe positive N1 and N2 amplification signals (Cq < 40) and negative RNase P signal (Cq > 35) due to target competition. This sample should be considered as Positive.