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RT- LAMP COVID-19 KIT THAI DUONG

RT-LAMP COVID-19 Kit THAI DUONG is based on Reverse transcription Loop-mediated isothermal amplification (RT-LAMP) technique, for the specific detection of SARS-CoV-2 virus. The assay contains all reagents necessary for the rapid and sensitive detection of a specific region of nucleocapsid gene (N) of SARS-CoV-2. Positive specimens are visually detected by observing the colour change from violet to sky blue.

Target gene  : N gene.

Running time : 30 minutes .

Sample type  : Nasopharyngeal swab/Oropharyngeal swab .

Reporting  : Visible to the naked eye; a colour change from violet to sky blue indicates the presence of SARS-CoV-2 RNA.
 .

PRODUCT

Performance  : 10 copies/reaction.

ADVANTAGES

ADAPTED TO LOW - RESOURCE AREAS

RAPID DETECTION

RT-LAMP COVID-19 Kit THAI DUONG is suitable for COVID-19 diagnosis at the point-of-care in low-resource settings such as local and field hospitals. The assay requires only a thermostatic bath and amplification products are detected by the naked eye.
 

The optimized assay requires only 30 minutes of incubation to achieve highly sensitive detection.

EXTENSIVE VALIDATION

HIGH ACCURACY

The assay has been validated on a panel consisting of 300 clinical samples, showing a sensitivity of 100% and a specificity of 99.65%. 

LoD = 10 genome equivalent copies/reaction. No cross-reaction with other respiratory viruses. 

PROCEDURE

INSTRUCTIONS FOR USE

<Mixing of Reagents and Samples> (Operate on ice)

Distribute 15 µL of each Master Mix
into each tube (well)

Add 15-20 μL (one drop) of mineral oil into the lid of reaction tube, close the lid carefully. seal the reaction tubes with parafilm 
 Wrap parafilm around tube cap
wrap parafilm around tube cap
wrap parafilm around tube cap

Spin down for 5 seconds

Mix the tubes by pipetting up and down 5 times

Add 10 μL of sample or control (NTC, PTC)
into each reaction tube

Read the results immediately

Incubate the reaction tubes at 65 ± 1℃ for 30 minutes

NTC: Water
PTC: Positive Control RNA

-  Be careful not to cause air-bubbles. 
- The colour of the mixture after sample addition should remain violet



This step is not required when using a PCR instrument
Do not seal tubes with parafilm when using a PCR instrument

DO NOT open reaction tubes after amplification

RESULT ANALYSIS

- An assay is considered valid if PTC will have turned sky blue while NTC should remain violet or blue-violet (see picture below).

- A sample is considered positive if at least one of duplicates will have turned sky blue.
- A sample is considered negative if the color of both duplicates are violet or blue-violet.
Caution: Reaction tubes must be put in a zip bag and disposed of in a biohazard box.

*The kit is stable for 12 months when stored at -23 to -18 oC in a standard freezer (without frost free cycles). See lot specific expiry date.
** GEC: genome equivalent copies.

DETAIL

CLINICAL EVALUATION

A clinical evaluation study was performed to evaluate the performance of the RT-LAMP COVID-19 Kit. The assay has been validated on a panel consisting of 300 clinical samples.  

All 15 positive specimens were found to be positive by the RT-LAMP COVID-19 Kit Thai Duong, showing a sensitivity of 100%. Results showed an overall concordance of 99,67% between the two assays.
Of note, the sample positive with RT-LAMP COVID-19 Kit Thai Duong and negative with Roche real-time RT-PCR was also tested positive with 2019-nCoV CDC Assays.

DETAIL

CERTIFICATE

EXPERT

Dr. Le Quang Hoa
Head of Laboratory of Gene Technology, school of Biotechnology anh Food Technology.
Hanoi University of Science and Technology.

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PLEASE FILL YOUR CONTACT

Address: 92 Vinhhung street, Hoangmai distrist, Hanoi City, Vietnam Country
Ms. Van: vannh@thaiduong.com.vn/+ 84916451269
Mr. Son: sonvdd@thaiduong.com.vn/+084943335511

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