FastProofTM 30 min – TTR SARS-CoV-2 RT-LAMP Kit
(Cat. No. ZE-P14)
(IVD: For In Vitro Diagnostic Use Only)
Thai FDA approved (number T6400110)
Product Description
FastProof™ 30 min-TTR SARS-CoV-2 RT-LAMP Kit used Colorimetric RT-LAMP (Reverse-Transcription Loop-Mediated Isothermal Amplification) technique, targeting N gene of SARS-CoV-2 and human RNase P gene as an internal control, allows fast, sensitive and specific detection of SARS-CoV-2 RNA under the controllable cost with 30 min Time-to-Test Results (TTR).
Intended Use
FastProof™ 30 min-TTR SARS-CoV-2 RT-LAMP Kit is a qualitative in vitro diagnostic test for the detection of nucleic acids from SARS-CoV-2 in nasopharyngeal and oropharyngeal (throat) swab from individuals who are suspected of COVID-19.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during infection. Positive results are indicative of SARS-CoV-2 RNA.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
Reagents Supplied
Components Included within the kit
| Components | Volume (µL) |
| Color LAMP-TTR (ZE-P15) | 1,200 |
| N primers mix-TTR (ZE-16) | 300 |
| RNase P primers mix-TTR (ZE-P17) | 300 |
| Positive control-TTR (ZE-P18) | 60 |
| Negative control-TTR (ZE-P19) | 60 |
Instruction Manual
1. Thawing of solutions. Take the Color LAMP-TTR, Primers mix-TTR, positive control-TTR, and negative control-TTR (RNase-free water) out from -20oC. Thaw all tubes at room temperature and place all tubes on cold rack at 4oC or on ice.
2. Preparation of RT-LAMP supermix for LAMP reactions
(Carry out in a biosafety cabinet, a laminar flow cabinet, or a clean closed-system cabinet such as a PCR cabinet workstation)
- 2.1 Mix 10 μL the Color LAMP-TTR (ZE-P15) with 5 μL of Primers mix-TTR. Pipette up and down gently several times to mix the solution.
- 2.2 Aliquot 15 μL of the RT-LAMP supermix into each of the PCR tubes.
- 2.3 Add 5 μL of extracted RNA to one of the reaction PCR tubes in the following order: Negative control-TTR, clinical specimen(s), and Positive control-TTR. Cover each well, spin down the reaction PCR tubes. For 5 seconds.
*This step of adding RNase-free water into the supermix (negative control) should be performed prior to adding RNA extracted from the tested samples and the RNA positive control.
Note: To prevent cross contamination, finish aliquoting the RT-LAMP supermix into the reaction tubes and preparing the negative control-TTR prior to touching the RNA templates for testing. Also, the work area for the preparation of the RT-LAMP supermix (always clean) and the work area for all activities involved with the tested RNA should be separated. - 2.4 Incubate the reaction PCR tubes at 65oC for 30 minutes in a thermal cycler or heating block.
Result Interpretation
- If the reaction solution turns yellow or orange, interprete as positive result or detected.
- If the reaction solution remains pink, interprete as negative result or not detected.
Zenostic 