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Point-of-Care products

Delivering compatible PCR solutions for Point-of-Care

SHARD DIAGNOSTICS™ Point-of-Care multiplex qPCR assays are designed for direct-on-sample testing from matrices such as blood, urine, saliva, and swabs, with no extraction required. Combined with rapid cycling conditions, they deliver gold-standard multiplex qPCR performance in a format compatible with point-of-care workflows, without compromising clinical output.

SHARD DIAGNOSTICS™ kit features

Each kit features lyophilized inhibitor-tolerant reagents that deliver consistent amplification even from challenging or impure samples, effectively eliminating performance variability caused by the sample. The universal chemistry supports all targets using a standardized cycling protocol, allowing multiple assays to run on the same 96-well plate. Quantified positive controls are included to standardise run performance across machines and provide quality control measures. The kits may be compatible with cartridge-based systems, contact us for more information.

Solutions not just kits

Universal cycling, common fluorophores and automation compatible for fast integration.

Complete kits

Quantified controls included as standard. Optional collection tubes provided.

Advanced performance

Extraction-free for RNA and DNA with high level multiplexing in as little as 30 minutes.

Available globally

All reagents are lyophilized for field use or device integration with ambient shipping.

Launch Program Definitions

The shard-dx™ product launch pathway allows customers to access the technology earlier with exciting rewards.

PRE-LAUNCH >
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ALPHA LAUNCH >
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BETA LAUNCH >
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AVAILABLE (RUO) >
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AVAILABLE (CE-IVD or FDA)
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Custom Point-of-Care kits

AVAILABLE (RUO): Custom qPCR kits

Find out more about custom PCR kits on our dedicated pages.
Format: Lyophilized inhibitor-tolerant qPCR or 1-step RT-qPCR.
Applications: Variant detection (DNA and/or RNA), gene expression, target quantification, target qualitative detection, extraction-free, rapid detection and cartridge-based system integration.
Targets: Singleplex or multiplex.
Detection method: Probe.
Shipping: Ambient.
Positive control inclusion: Yes.
Regulatory status: Research Use Only (RUO).
Sample type: Flexible (DNA, RNA or DNA/RNA combined).
Product code (SKU): SDCA_CUSTOMER LAST NAME_ORDER NUMBER.

PRE-LAUNCH (RUO): Custom amplicon sequencing kit

Find out more about custom PCR kits on our dedicated pages.
Format: Lyophilized inhibitor-tolerant PCR or 1-step RT-PCR.
Applications: Variant detection, gene expression, target qualitative detection and extraction-free.
Targets: Multiplex, long and short read.
Sample type: Flexible (DNA, RNA or DNA/RNA combined).
Shipping: Ambient.
Positive control inclusion: Yes.
Development status: Pre-launch. Ongoing research and development with established lyophilized inhibitor tolerant shard-dx™ platforms.
Regulatory status: Research Use Only (RUO).
Pre-launch program: Join the shard-dx™ pre-launch program to generate cutting-edge kits alongside us. Find out more on the launch programs definition section on each custom page and product page.
Product code (SKU): SDCA_CUSTOMER LAST NAME_ORDER NUMBER.

Point-Of-Care Compatible Kits (qPCR)

BETA LAUNCH: RNR1 SNP genoptying (direct: saliva/swab) kit

Product name: LyoMorph-Q RNR1 direct-SNP kit
Product code (SKU): SD_HMB_00028
Format: qPCR - lyophilized and inhibitor-tolerant
Potential use cases / info: The shard-dx™ RNR1 kit does not require saliva or swab material to be diluted but does require the use of shard-dx™ collection tubes. Detection of RNR1 SNPs may play a role in detecting potential toxicity to some antibiotics for individuals, possibly prenatal/infant stages with sepsis at the point-of-care setting. Detection of the SNPs may be useful to determine parents hereditary risk of toxicity to some antibiotics as a screening tool. This test may be performed in a lab or is compatible with point-of-care by producing results in a rapid time frame (<60 minutes) without sample pre-processing in 2 pipetting steps.
Development status: Beta launch. Multiplex optimisation in finalisation.
Targets (Reaction 1):
- RNR1 [m.1555A>G] (FAM)
- RNR1 [m.1494C>T] (FAM)
- RNR1 [m.1095T>C] (HEX)
- RNase P [internal control] (ATTO 647)
Total typical qPCR run time (machine-dependant): 42 minutes
Limit of Detection - copies (95%): 200 copies - approximately 0.2 cells
Detection method: Probe
Sample type: direct saliva or direct swab collected in shard-dx™ prescribed tubes
Reactions: 96 / 1000
Shipping: Ambient
Number of mastermixes: 1
Number of reactions required per sample: 1
Positive control inclusion: Yes
Regulatory status: Research Use Only (RUO)
Beta-launch program: Join the shard-dx™ beta launch program to generate cutting-edge kits alongside us. Find out more on the launch programs definition section on each custom page and product page.

Didn't find your target or configuration? Try Custom.

Custom: Express PCR kits

Low scale (96 reactions) to high scale lyophilized inhibitor tolerant qPCR and 1-step RT-qPCR kits for your target.

Custom: OEM/White-label kits

License from us to gain an edge over the competition with industry-leading performance. Available in your branding.

Custom: Clinically focused applications

Your clinical application combined with our technology, completely custom with the option for extensive performance testing.

Custom: Academic collaborations

Collaborate with shard-dx™ to gain access to our innovative technology and support for rapid progression together.

Request a quote or consultation

Information

Products

Custom Kits

Contact Us

Location:

BioCity Nottingham, Pennyfoot Street, Nottingham, England, NG1 1GF

Email:

info@shard-dx.com

UK. Registered No 15798577

SHARD DIAGNOSTICS™ and shard-dx™ are trademarks of SHARD DIAGNOSTICS LTD. All rights reserved.