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FlashDetect LyocartE SARS-CoV-2 Assay, All-in-One PCR Cartridge, 24 Tests

Vendor: Coyote Bioscience

SKU: 6018007102-CE

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FlashDetect LyocartE SARS-CoV-2 Assay - FlashDetect LyocartE SARS-CoV-2 Assay is a ready-to-use All-in-One PCR cartridge for the FlashDetect molecular point-of-care systems: simultaneous real-time PCR detection of SARS-CoV-2 from nasal, nasopharyngeal or oropharyngeal swab with the sample preparation, amplification and result interpretation automated inside the sealed cartridge.

Results in 20-30 mins
LoD as low as 100 copies/mL
Includes internal control
Pre-loaded with lyophilized reagents
Contamination-free
Room temperature storage and transportation

Specifications

Method	Real-time PCR (All-in-One cartridge)
Product Name	FlashDetect™ LyocartD SARS-CoV-2 Assay: Method; FlashDetect™ LyocartE SARS-CoV-2 Assay: Real-Time PCR All-in-one cartridge integrates sample prep and PCR amplification
Gene Targets	ORF1ab, N, RNP IC gene
LoD	100 copies/mL
Clinical Sensitivity	100.00% (100/100, 95% CI: 96.38% to 100.00%); 100.00% (267/267, 95% CI: 98.63% to 100.00%)
Clinical Specificity	99.33% (298/300, 95% CI: 97.61% to 99.92%): Detection Time; 99.38% (319/321, 95% CI: 97.77% to 99.92%): 15 mins - 25 mins
Sample Type	Nasal, Nasopharyngeal or Oropharyngeal Swabs
Detection time	Within 36 mins
Cartridge format	LyocartE - with integrated nucleic-acid extraction
Compatible instruments	FlashDetect Nano, Flash10
Tests per kit	24
Storage temperature	2-28 °C (ready-to-use lyophilized reagent)
Registration	CE IVD
Manufacturer	Coyote Bioscience Co., Ltd. (Beijing, China)

Cartridge versions

Code	Version
6018007102-CE	SPEC. A - direct swab (sample buffer in the sample chamber)
6018007105-CE	SPEC. B - sampling via VTM/UTM (no sample buffer)

SPEC. A cartridges carry the sample buffer in the sample chamber for direct swab loading; SPEC. B cartridges have no sample buffer and are loaded from a swab eluted in viral/universal transport medium (VTM/UTM).

Workflow

FlashDetect LyocartE SARS-CoV-2 Assay workflow

Ordering

Code	Price-list description	Version
6018007102-CE	FlashDetect SARS-CoV-2 Assay Spec A 24t	SPEC. A
6018007105-CE	FlashDetect SARS-CoV-2 Assay Spec B 24t	SPEC. B

Documents

Specifications

Applications Respiratory Tract Infections - molecular point-of-care detection of SARS-CoV-2
Assay time Within 36 mins
Compatible with FlashDetect Nano, Flash10
Country of origin China
Format Single-use sealed cartridge
Instruments FlashDetect NanoFlash10
Method Real-time PCR
Pack size 24 tests/kit
Regulations CE IVD
Sensitivity LoD 200 copies/mL
Specialized sample types Nasal, nasopharyngeal or oropharyngeal swab
Storage conditions 2-28 °C
Sub category Respiratory Tract Infections
Technology All-in-One lyophilized cartridge, integrated nucleic-acid extraction (LyocartE)

links and documants

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Datasheet url Click here
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