Product

PRODUCT

LAMPlexTMRT-qLAMP COVID-19 Detection Assay

What is LAMPlex RT-qLAMP COVID-19 Detection Assay?

LAMPlex™ RT-qLAMP COVID-19 Detection Assay using real-time reverse transcription loop-mediated isothermal amplification method is an in vitro diagnostic medical device for the qualitative detection of 2019-nCoV gene (N gene) from human nasopharyngeal swab, oropharyngeal swab and sputum samples.

Kit Contents

LAMPlex™ RT-qLAMP COVID-19 Detection Assay using real-time reverse transcription loop-mediated isothermal amplification method is an in vitro diagnostic medical device for the qualitative detection of 2019-nCoV gene (N gene) from human nasopharyngeal swab, oropharyngeal swab and sputum samples.

No Product name Volume EA Cap
1 2X RT-LAMP Master Mix 1,250 ㎕ 1 tube 2X RT-LAMP Master Mix
2 RT-LAMP Enzyme Mix 100 ㎕ 1 tube RT-LAMP Enzyme Mix
3 Primer Mix 200 ㎕ 1 tube Primer Mix
4 Positive Control Template 250 ㎕ 1 tube Positive Control Template
5 Nuclease Free Water 1,000 ㎕ 1 tube Nuclease Free Water

Storage and Shelf Life

1) Shelf Life: 6 months
2) Storage: -20 ± 5 °C

Product Information

1. Package
· 100 Tests/Kit

2. Target Gene
· N Gene

3. Applicable Samples
· Nasopharyngeal, Oropharyngeal Swabs, Sputum

4. Limit of Detection (1 x 102 copies/reaction)
· Sensitivity: 100%
· Sensitivity: 100%

5. Clinical Trial Accuracy(110 positive cases, 110 negative cases)
· Positives: 98.2% (108/110)
· Negatives: 99.1% (109/110)

6. Amplification Time
· 15 min

7. Technology
· Loop- mediated isothermal amplification

8. Applicable Instruments
· Almost all available PCR Machines

9. Storage
· -20 ± 5 °C

10. Shelf Life
· 6 months

11. Certificate
· CE, Korea FDA

Clinical Evaluation

Reference Product (EUA Approved)
(+) (-) Total
LAMPlex™ RT-qLAMP COVID-19 Detection Assay, CellSafe (+) 108 1 109
(-) 2 109 111
Total 110 110 220

– Positive Agreement = 98.2% (95% Confidence Interval: 93.6%)
– Negative Agreement = 99.1% (95% Confidence Interval: 95.0%)
– Agreement = 98.6%
– Cohen’s Kappa: 0.97[Almost perfect]
– By GC Labs

No. Specimen EUA Approved Product (RT-PCR) LAMPlex™ (CellSafc)
Ct(E gene) Ct(Rd gene) Ct(N gene) Ct(IC) Ct(N gene)
1 Nasopharyngeal/Oropharyngeal 26.45 27.66 28.7 27.64 18.67
2 Nasopharyngeal/Oropharyngeal 26.43 26.86 28.42 27.64 18.51
3 Nasopharyngeal/Oropharyngeal 14.44 17.04 17.41 N/A 10.72
4 Nasopharyngeal/Oropharyngeal 21.87 22.97 24.49 23.56 16.14
5 Nasopharyngeal/Oropharyngeal 26.95 27.75 57min (45 sec/cycle) 25.01 20 min (30 scc/cyclc)
6 Nasopharyngeal/Oropharyngeal 20.81 22.18 24.12 26 15.11
7 Nasopharyngeal/Oropharyngeal 25.89 26.53 28.3 24.75 17.14
8 Sputum 23.41 24.11 26.97 24.49 19.91
9 Nasopharyngeal/Oropharyngeal 14.24 15.48 48 min (45 sec/cycle) N/A 15 min (30 scc/cyclc)
10 Nasopharyngeal/Oropharyngeal 14.86 15.91 18.35 38.79 11.07
11 Nasopharyngeal/Oropharyngeal N/A N/A N/A 25.88 N/A
12 Nasopharyngeal/Oropharyngeal N/A N/A N/A 25.39 N/A
13 Nasopharyngeal/Oropharyngeal N/A N/A N/A 26.51 N/A
Cat No. CellSafe Other RT-PCR
Technology Loop-mediated Isothermal Amplification
(Detection of Nuclcic Acid)
RT-qPCR
(Detection of Nuclcic Acid)
Amplification Temperature 50 /63°C Ex) 55,94,58,12˚C
Applicable Instruments Almost all available PCR machines including Portables Expensive PCR Machines
Samples Nasopharyngeal, Oropharyngeal Nasopharyngeal, Oropharyngeal
Test Time 1) 50°C: 10 min     2) 63°C:15min About 2 hours
Sensitivity* 100% Different claims by manufacturer
Specificity* 100% Different claims by manufacturer
Storage – 20°C – 20°C

*LOD: Limit of Detection (100 copies/reaction) 

Ordering Information

Cat No. Product name Package Kit Size (mm)/ Weight Box
CSCOLAN- 100 LAMPlex™
RT-qLAMP COVID-19 Detection Assay
100 Tests/Kit 65x45x55/ 100g 10 kits/Box

How to report Adverse Events or Problems

If you face any adverse events or problems with LAMPlexTM RT-qLAMP COVID-19 Detection Assay, please contact us immediately.

Sample Request

If you need a sample for LAMPlex RT-qLAMP COVID-19 Detection Assay, please contact us.

If you need a sample for LAMPlex RT-qLAMP COVID-19 Detection Assay, please contact us.

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