COVID-19 RT-qPCR Detection Kit Plus

Catalog numberQP019T-0100

Size100 Reactions

StorageStable for up to 1 year at -20 °C

CategoriesIVD Products

$600 Inquire

Note: COVID-19 / SARS-CoV-2 / RT-qPCR / N1 Gene / TFDA

Description

In view of the joint global efforts of advancing collaborative research in diagnostics, therapeutics, and vaccination in the fight against the COVID-19 (SARS-CoV-2) pandemic, we have specifically developed the LifeDireX COVID-19 RT-qPCR Detection Kit Plus for human respiratory tract specimens.

The COVID-19 RT-qPCR Detection Kit Plus is a multiplex real-time RT-PCR (RT-qPCR) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 for human respiratory tract specimens (such as nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) from individuals suspected of COVID-19 by their healthcare provider. Results are for the identification of SARS-CoV-2 RNA.

The kit is characterized by:

High specificity for the N target markers as recommended by WHO and US CDC.
Data obtained in less than 2 hours.
Compatible with standard RT-qPCR machines.

Kit Contents

Component	Description	Amount Supplied (per 100 rnxs)
2X RT-qPCR MasterMix	Multiplex assay primers/probes for N1 and RP (human) genes with HotStart DNA polymerase, dNTPs, and buffer	1000 μl x 1
RScript Enzyme Mix	RScript reverse transcriptase with RIBOAssure RNase inhibitor	20 μl x 1
Positive Control	Pseudo-virus DNA containing N1 gene	50 μl x 1
Negative Extraction Control	Cancer cell line with RP gene	1 ml x 1
Nuclease-Free Water	DEPC-treated water	1 ml x 1

Application

Gene Expression (mRNA) Analysis
Copy Number Analysis
SNP Genotype Analysis

Storage and Handling Requirements

COVID-19 RT-qPCR Detection Kit Plus is shipped with dry ice and gel packs.
All components of the kit arrive in solution.
All components of the kit must be stored at -20 °C upon arrival.
Do not use kit components after expiration date printed on the box label.
If there is damage to the packaging inside, outside or kit contents have been tempered with, or storage condition failed to meet above -20 °C, do not use.
Dispose of unused reagents and waste in accordance with country, federal, state, and local regulations.
Repeated freezing and thawing may lead to inaccurate results.
The kit is stable for up to 1 year from date of release.

Note: Inaccurate results may be obtained if the kit is not handled according to the instructions provided.

Interpretation of Results

SARA-CoV-2		Interpretation	Action
N1	RP	Interpretation	Action
+	+/-	Positive	Report results to health authority.
-	+	Negative	SARS-CoV-2 not detected. Report results to helath authority.
-	-	Invalid Result	Repeat from extraction step. If the repeated result remains invalid, recommend collection of a new specimen(s) from the patient.

A study was performed to assess the performance of COVID-19 RT-qPCR Detection Kit Plus. A testing of 20 replicates at the tentative Limit of Detection (LoD) concentration was carried out with 50 copies/reaction at 95% detection rate. Samples were spiked SARS-CoV-2 RNA in pooled negative clinical nasopharyngeal swab matrix, then extracted with QIAamp Viral RNA Mini Kit and tested on QuantStudio™ 5 Real-Time PCR System. The synthetic SARS-CoV-2 RNA was obtained from Twist Biosciences (Assay Ready Control 14,EPI_ISL_710528).

Limit of Detection (LoD)

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