Page 28 - Brochure Hibergene

Instructions for Use
12. Interferents
The impact of the following potentially inhibitory substances at the concentrations listed below was assessed by testing multiple replicates of COVID-19 positive and negative simulated swab samples in the presence of the substances.
Potential inhibitor
Concentration
Whole Blood
0.1%
Mucin
50μg/ml
Genomic DNA
10ng/μl
The data indicates that whole blood at the concentration listed above may be inhibitory to the HG COVID-19 assay. Care should be taken to avoid testing samples contaminated with whole blood.
13. Equivalency Studies – Transport Media
An equivalence study was carried out using the following transport media and swab combinations:
􏰀 3ml Copan UTM + Copan Flocked Swab (Copan, Cat. No. 306C)
􏰀 3ml Puritan UniTranz + Flocked Swab PurFlock Ultra (Puritan Medical
Products Cat. No. UT-306)
􏰀 2ml Virocult + mini foam swab (Medical Wire, MW950SENT)
Positive and negative samples were prepared. Negative samples consisted of the transport media listed above. Positive samples were generated by spiking the transport media with SARS-CoV-2 (Strain USA-WA1/2020, Zeptometrix Cat. # 0810587CFHI) to a final concentration of 30 TCID50/ml. All samples were tested across multiple validation batches of product using the direct method. No significant difference in amplification time of either the target or the EC was observed, demonstrating the equivalence of the transport media in terms of performance.
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