Covid-19

SARS Kits e test VirSNiP

Kit per RT-PCR e test di mutazione VirSNiP per la sorveglianza dei ceppi

All'inizio del 2020, SARS-CoV-2 si è diffuso dall'Asia in tutto il mondo causando la prima grande pandemia del secolo. TIB Molbiol è stata una delle prime aziende ad arrivare sul mercato con un kit per SARS e offre kit in PCR per COVID-19 dall'inizio di gennaio 2020. Negli ultimi 12 mesi abbiamo consegnato oltre 60 milioni di test. Particolare attenzione va riservata alle diverse varianti di COVID-19 che circolano in tutto il mondo. Queste varianti sono state segnalate per avere una maggiore infettività, morbilità o mortalità. Abbiamo sviluppato una varietà di test VirSNiP che rilevano le mutazioni note. Questi saggi possono essere integrati negli algoritmi di test di routine. Il nostro dipartimento di ricerca e sviluppo analizza costantemente le sequenze di SARS-CoV-2 per essere aggiornato sulle più recenti varianti che possono influenzare le prestazioni dei nostri kit.

Questa pagina contiene una panoramica dei test attualmente disponibili. A causa dello sviluppo dinamico della pandemia, continueremo a implementare nuovi test secondo necessità.

SARS RT-PCR test kits

FAM label Coronavirus detection

53-0775-96	Sarbeco N gene
53-0776-96	Sarbeco E gene
53-0777-96	SARS-CoV-2 RdRP

to be combined with an extraction control Cy5 channel

66-0909-96	EAV spiked target
66-0914-96	UBC human mRNA

90-9999-96	1-step RT polymerase (dry)

ModularDx kits are building blocks for multiplex PCR
One vial contains 96 reactions each 20 µl
Positive control is included
Polymerase and extraction kit not included

Product is dried - storage 4°C to 25°C
Shipping without temperature control
Frost exposure and temperatures up to 45°C tested

IFU for use with Roche 480 instruments
FAM labelled TaqMan assays can be utilised on any qPCR instrument (no instructions provided)

Standard run time approx 1 hour
FastCycling program 45 min run time

40-0776-96	Sarbeco E gene + EAV
90-9999-96	1-step RT polymerase

IFU for use with Roche 480 instruments
FAM and Cy5 label TaqMan assays can be utilized on any qPCR instrument minimum Fam and Cy5 channel (no instructions provided)

40-0770-96	Dual Target SARS + UBC
90-9999-96	1-step RT polymerase

Product tested evaluated with heat-treated gargle solution (no extraction required)

IFU for use with Roche 480 instruments Cyan500, FAM and HEX label TaqMan assays. Can be applied on any qPCR instrument minimum Fam and HEX channels (no instructions provided)

60-0770-96	SARS-Cov-2 N gene

HEX	SARS-Cov-2 N gene
ROX	Sarbeco E gene
Cy5	UBC extraction control

Roche LightCycler® 480 II

50-0776-96	Sarbecovirus SARS-CoV-2
53-0101-96	Influenza A
58-0102-96	Influenza B
61-0110-96	RSV-A/B
64-0134-96	Picornavirus
66-0909-96	EAV extraction control

* IVD registration pending
Distributed by Roche Diagnostics

cobas z 480 Analyzer


53-0101-96	Influenza A
58-0102-96	Influenza B
61-0110-96	RSV-A/B
64-0776-96	SARS-CoV-2*
66-0909-96	EAV extraction control
70-0110-96	RSV-A/B*

SARS testing only (any instrument FAM and Cy5 channel)

50-0776-96	Sarbecovirus SARS-CoV-2
66-0990-96	EAV extraction control

50-0776-96	Sarbecovirus SARS-CoV-2
66-0914-96	UBC human mRNA

and Roche LightCycler^® Multiplex RNA Virus Master Cat.-No. 06 754 155 001 or

90-9999-96

1-step RT polymerase (dry)

Probe-based melting curve assays for testing for common mutations in the SARS genome, enabling screening for emerging strains such as B.1.1.7 (UK variant).

A high melting peak is an indication of the presence of the variant of interest. The 'wild type' sequence shows a peak with lower Tm; other variants are expected to yield even lower melting peaks.

IFU is for use with Roche 480 instruments. Other instrument with a SYBR Green melting curve capabilities can be used; programming should be adapted to a heating rate of approx 0.2°C / sec

TIB MOLBIOL VirSNiP Omicron Variant Assays (RUO)

Spike S371LS373P

Detects Omicron specifically (new mutations) -differentiates BA.1 / BA.2 (RUO)

Spike L452R + S371L S373P

Distinguishes Delta & Omicron in a single test - differentiates BA.1 / BA.2 (RUO)

Spike R346T

Detects Omicron (new mutation) BA.2.75.2, BA.4.6, BQ1.1 (RUO)

Spike E484A-F486S

Updated E484A assay, - detects Omicron by melting shift BA.1 / BA.4/.5 / BA.2.75.2 (RUO)

Spike N460K

Detects Omicron (new mutation) BA.2.75.2, XBB, BQ.1 (RUO)

Spike A67V del69/70

Updated del69/70 assay, - better resolution for BA. 1 deletion 69/70 (RUO)

VirSNiP strain identification integrated in routine testing

Roche 480	Instrument requirements : FAM (melting) / Cy5
50-0776-96	Sarbecovirus SARS-CoV-2
53-0780-96	SARS Spike N501Y (or other VirSNiP assay)
66-0990-96	EAV extraction control

Complete Kit	Instrument requirements : FAM (melting) / HEX / ROX / Cy5
53-0780-96	SARS Spike N501Y
60-0770-96	Dual Target SARS + UBC

FAM	Virus mutation
HEX	SARS-Cov-2 N gene
ROX	Sarbeco E gene
Cy5	UBC human extraction control

Complete Kit	Instrument requirements : FAM (melting) / HEX
53-0780-96	SARS Spike N501Y
40-0770-96	Dual Target SARS + UBC

FAM	Virus mutation
HEX	UBC human extraction control

Winterplex®	Instrument requirements : 500 / FAM (melting) / HEX / ROX / 640 / Cy5
50-0776-96	Sarbecovirus SARS-CoV-2
53-0780-96	SARS Spike N501Y (or other VirSNiP assay)
53-0101-96	Influenza A
58-0102-96	Influenza B
61-0110-96	RSV-A/B
64-0134-96	Picornavirus

66-0990-96	EAV extraction control