COVID-19 + FluA & B testing kit

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Product Description

To address the annual Influenza season coinciding with the continued threat of COVID-19, there is a need for diagnostics that can detect COVID-19 and/or Influenza, and differentiate between them to help direct patient management.

The C/Tech SARS-CoV-2 and Influenza+ detection kit was designed for use in research laboratories. The kit can also be deployed at clinics or hospitals, centralized laboratories or contracted testing providers. It is based on the Real-time PCR (RT-PCR) technology developed by Hai Kang Life Corporation (HKLife), targeting genes in the genomes of SARS-CoV-2 and Influenza viruses, and utilizing fluorescence probes for detection. HKLife’s detection test is CE-IVD approved.

Features

  • Taqman Reverse Transcription PCR
  • Genes in SARS-CoV-2, Influenza A and Influenza B as target
  • Human RNase P as internal control
  • Manufactured in ISO 13485 compliant facility

Benefits

  • Highly sensitive – Detect as low as 40 viral copies/µL
  • Highly specific – No cross-reactivity with 38 human respiratory pathogens
  • Fast TAT – Sample to result in less than 3 hours
  • Ease of use – Pre-mixed reaction reagents

Specifications

  • 100 reactions per kit
  • Acceptable samples collected from throat swabs and nasal swabs
  • Required real-time PCR machine: Applied Biosystems Real Time PCR System 7500 or BioRad CFX96TM fluorescent quantitative PCR system
  • Limit of detection for throat swab samples: 40 viral copies/µL
  • Reagents stable under dark for 12 months at -20°C

Key Components

  • 2 x 710 μl RT-qPCR Mastermix
  • 1 x 80 μl RT-qPCR Enzyme Mix
  • 1 x 250 μl Positive Control
  • 1 x 1 ml Nuclease-free Water

Product Catalog Number

C02-01-1183-100

Performance Characteristics

1. Limit of Detection (LoD): 40 copies/μL (Throat Swabs)

The contrived sample condition was nucleic acids extracted from pooled oropharyngeal (OP) swab samples and spiked with synthetic SARS-CoV-2, influenza A or influenza B control sequences (Twist Biosciences). The pooled OP swab matrix was first confirmed negative using C/Tech SARS-CoV-2 and Influenza+ detection kit, and then a total of five dilutions of viral sequences were prepared using the nucleic acid extracted from the negative matrix. Three replicates per concentration were tested.

The five dilutions tested were 160, 80, 40, 20, 10 copies/reaction for the three target sequences and provisional LoDs of 20-40 copies/reaction were obtained. Final LoDs of 40, 20 and 40 copies/reaction were confirmed for SARS-CoV-2, Influenza A and Influenza B, respectively, by testing in replicates of 20 (Table 1).

Table 1. Sensitivity of C/Tech SARS-CoV-2 and Influenza+

Target level
(Copies/reaction)

Valid tested replicates

SARS-CoV-2

RNase P
(internal control)

n

Mean Ct

Detection rate (%)

n

Mean Ct

Detection rate (%)

40 (SARS-CoV-2)

20

20

34.17

100

20

27.48

100

20 (SARS-CoV-2)

20

17

34.92

85

20

27.42

100

Target level

(Copies/reaction)

Valid tested replicates

Influenza A

RNase P

(internal control)

40 (FluA)

20

20

33.65

100

20

27.48

100

20 (FluA)

20

19

34.62

95

20

27.42

100

Target level

(Copies/reaction)

Valid tested replicates

Influenza B

RNase P

(internal control)

40 (FluB)

20

20

31.84

100

20

27.48

100

20 (FluB)

20

18

32.46

90

20

27.42

100

2. Analytical Specificity

Cross-reactivity against a list of pathogens potentially found in the respiratory tract (Table 2). All 38 target templates tested negative using the SARS-CoV-2 or Influenza primers/probes set.

Table 2. List of pathogens tested in specificity validation of primers and probes

Virus

229E

SARS

H1N1*

RHV

RSV (A,B)

OC43

SARS-CoV-2*

H3N2*

MPV (A,B)

Adv (1,2; DNA)

HKU1

MERS

FluB*

EV (A-D)

HPIV (1-4)

NL63

Bacteria

H. influenzae

S. pyogenes

C. pneumoniae

S. epidermis

M. tuberculosis

P. aeruginosa

L. pneumophila

M. pneumoniae

S. salivarius

B. pertussis

S. pneumoniae

Fungi

C. albicans

P. jirovecii (PJP)


229E, Human coronavirus 229E; OC43, Human coronavirus OC43; HKU1, Human coronavirus HKU1; NL63, Human coronavirus NL63; SARS, Severe acute respiratory syndrome-associated virus;
SARS-CoV-2, Severe acute respiratory syndrome-associated virus 2; MERS, Middle-East respiratory syndrome-associated virus; H1N1, Influenza A virus subtype H1N1; H3N2, Influenza A virus subtype H3N2; FluB, Influenza B virus; RHV, Rhinovirus; MPV, Metapneumovirus; EV, Enterovirus; RSV, Respiratory syncytial virus; HPIV, Human parainfluenza virus; Adv, Adenovirus

*SARS-CoV-2 tested against Influenza primer/probe set; H1N1, H3N2, FluB tested against SARS-CoV-2 primer/probe set

All data are available upon request

If you are interested in jointly combatting Covid-19 and reducing possibilities of misdiagnosis and avoid mistreatment,
Please don’t hesitate to reach out to us!

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