UNIVERSAL COLLECTION TRANSPORT MEDIUM – FOR CLINICAL USE

IAB-UCTM

stabilization of RNA/DNA at 4-25 °C
sterility tested
clinical application: swab
CE marked IVD

IAB-UCTM is a CE marked universal medium for the collection and transport of swabs for in vitro diagnostic testing on the presence of genetic material (i.e. viral RNA, human DNA/RNA) by (RT-)qPCR or other molecular methods.

performance information

Stability of viral RNA in nasal swab sample: stability up to 72 hr, 4-25 °C
Stability of human RNA in nasal swab sample: stability up to 72 hr, 4 °C
Stability of human DNA in nasal swab sample: stability up to 72 hr, 4-25 °C
Freeze/thaw stability
Comparable performance as CE marked, commercially available UTM^®1
IAB-UCTM is not intended to inactivate pathogens

^{¹ is a registered trademark of Copan group}

The figures below show key performance parameters for IAB-UCTM

Stability of viral RNA

platform	RNA extraction and RT-qPCR assays	storage temperature	nasal swab sample		IAB-UCTM	other CE marked UTM^®1
platform	RNA extraction and RT-qPCR assays	storage temperature	nasal swab sample		evaluation on day 0 / 2 / 3
Seegene STARlet (Seegene) and CFX96 (Bio-Rad)	STARMag 96 X 4 Universal Cartridge Kit (Seegene) and AllplexSARS-CoV-2/Flu A/Flu B/RSV Assay (Seegene)	20-25 °C	RSV:	strong positive	+	+
				weak positive	+	+	(day 2)
						-	(day3)
			influenza A:	strong positive	+	+
				weak positive	+	+
			SARS-CoV-2:	strong positive	+	+
				weak positive	+	+
Panther Fusion (Hologic)	SARS-CoV-2/Influenza A/B/RSV assay	20-25 °C	RSV:	strong positive	+	+
			RSV:	weak positive	+	+
			influenza A:	strong positive	+	+
			influenza A:	weak positive	+	+
			SARS-CoV-2:	strong positive	+	+
			SARS-CoV-2:	weak positive	+	+
geneXpert (Cepheid)	Xpert Xpress SARS- CoV-2/Flu/RSV assay	4 °C	RSV:	strong positive	+	+
			RSV:	weak positive	+	+
			influenza A:	strong positive	+	+
			influenza A:	weak positive	+	+
			SARS-CoV-2:	strong positive	+	+
			SARS-CoV-2:	weak positive	+	+
¹is a registered product of Copan group

Table: Evaluation of clinical result for positive swab samples re-evaluated as a 10-fold dilution in IAB-UCTM or other commercially available CE marked UTM®¹ on different platforms and storage conditions: all originally positive samples remained positive at day 0, 2 and 3.

Graphical presentation of viral RNA stability in IAB-UCTM and UTM®¹ of competitor for nasopharyngeal samples stored at 4 °C and evaluated on GeneXpert (Cephied) platform