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FlashDetect LyocartE SARS-CoV-2&Flu A&Flu B Assay, All-in-One PCR Cartridge, 24 Tests

Vendor: Coyote Bioscience

SKU: 6018007202-CE

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FlashDetect LyocartE SARS-CoV-2&Flu A&Flu B Assay - Simultaneous detection of 3 respiratory infections in one cartridge:

Results in 20-30 mins
LoD as low as 100 copies/mL (SARS-CoV-2)
Includes internal control
Pre-loaded with lyophilized reagents
Contamination-free
Room temperature storage and transportation

SARS-CoV-2 (ORF1ab, N gene), Influenza A (M gene) and Influenza B (NS1 gene) .

Specifications

Method	Real-time PCR (All-in-One cartridge)
Product Name	FlashDetect™ LyocartD SARS-CoV-2&Flu A&Flu B Assay: Method; FlashDetect ™ LyocartE SARS-CoV-2&Flu A&Flu B Assay: Real-Time PCR All-in-one cartridge integrates sample prep and PCR amplification
Analytes	SARS-CoV-2 (ORF1ab gene, N gene), Influenza A (Flu A), Influenza B (Flu B), Internal Control (RNase P gene)
LoD	200 copies/mL(SARS-CoV-2); 500 copies/mL(FluA/FluB); 100 copies/mL(SARS-CoV-2); 500 copies/mL(FluA/FluB)
Clinical Sensitivity	SARS-CoV-2: 100.00% (149/149,95% CI: 97.49% to 100.00%) Flu A: 100.00% (49/49, 95% CI: 92.73% to 100.00%) Flu B: 100.00% (50/50, 95% CI: 92.86% to 100.00%); SARS-CoV-2: 100.00% (267/267, 95% CI: 98.63-100.00%) Flu A: 100.00% ( 170/170, 95% CI: 98.25-100.00%) Flu B: 100.00% (193/193, 95% CI: 98.46-100.00%)
Clinical Specificity	SARS-CoV-2: 99.34% (150/151, 95% CI: 96.34% to 99.88%) Flu A: 99.60% (250/ 251, 95% CI: 97.78% to 99.93%) Flu B: 100.00% (250/250, 95% Cl: 98.49% to 100.00%): Detection Time; SARS-CoV-2: 99.75% (807 /809, 95% CI: 99.11-99.97%) Flu A: 100.00% (906/906, 95% CI: 99.67-100.00%) Flu B: 100.00% (883/883, 95% CI:99.66-100.00%): 20 mins - 30 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
6018007202-CE	SPEC. A - direct swab (sample buffer in the sample chamber)
6018007205-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&Flu A&Flu B Assay workflow

Ordering

Code	Price-list description	Version
6018007202-CE	FlashDetect SARS-CoV-2&Flu A&Flu B Assay Spec A 24t	SPEC. A
6018007205-CE	FlashDetect SARS-CoV-2&Flu A&Flu B Assay Spec B 24t	SPEC. B

Documents

Specifications

Applications Respiratory Tract Infections - molecular point-of-care detection of SARS-CoV-2 / Flu A / Flu B
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 (SARS-CoV-2); 500 copies/mL (Flu A/Flu B)
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

Brochure url Click here
Datasheet url Click here
Source url Click here