EVALUATION RESULTS OF NUCLEIC ACID EXTRACTION KITS
Last updated: 28 December 2020
Nucleic acid amplification tests for the detection of infectious disease pathogens, require good quality nucleic acid material as a prerequisite. The quality of isolated nucleic acid from clinical specimens directly affects quality of the diagnostic test result. Various technologies are currently available to extract/isolate nucleic acids from clinical specimens. For the purpose of laboratory diagnosis of COVID-19, the ribonucleic acid is extracted primarily from respiratory specimens such as nasopharyngeal and oropharyngeal swabs.
Evaluation of nucleic acid extraction kits is crucial in ensuring that the yield of nucleic acid material is of sufficient quantity, quality, purity, and integrity, suitable for the assays to be used, such as Real-Time PCR detection of SARS-CoV-2 virus.
Given that the nucleic acid extraction kit performance evaluation performed here is specifically intended to assess the applicability for SARS-CoV-2 detection by Real-Time PCR, the evaluation involves an estimation of the concordance of SARS-CoV-2 Real-Time PCR results generated from the nucleic acid extraction yield of a reference nucleic acid extraction method and the method/kit under evaluation.
A verification panel, comprising of a set of clinical specimens of known reactivity (known SARS-CoV-2 PCR result) is used, where each specimen is extracted in parallel using the two methods, to facilitate comparative evaluation. Result concordance between the two extraction methods (reference method vs the method under evaluation) is then estimated, using Real-Time PCR assays of established and acceptable performance characteristics.
Read more about the guidelines on the evaluation of in vitro diagnostic medical devices and other related laboratory diagnostic supplies for COVID-19 here.
results
| # | Nucleic Acid Extraction Kit | Manufacturer | Catalog number | Concordance Rate | Date Performed | ||||
|---|---|---|---|---|---|---|---|---|---|
| Sansure Biotech 2019-nCoV | XAbt Multiple Real-time PCR kit | A*Star Fortitude Kit 2.0 | BGI Real-time Fluorescent RT-PCR kit | MirXes Fortitude 2.1 | |||||
| 1 | QIAamp Viral RNA mini kit | Qiagen | 50preps/Cat. No. 52904 250preps/Cat. No. 52906 |
100% | 100% | 100% | 100% | April 18, 2020 | |
| 2 | Purelink Viral RNA/DNA kit | Invitrogen Corp. | 50preps/Cat. No. 12280050 | 100% | 100% | 100% | 100% | April 18, 2020 | |
| 3 | Monarch Total RNA Miniprep kit | New England Biolabs | 50preps/Cat. No. T2010S | 100% | 100% | 100% | 100% | April 18, 2020 | |
| 4 | Genejet Viral RNA/DNA Kit | Thermo Fisher Scientific | 50preps/Cat. No. K0821 | 100% | 100% | 100% | 100% | May 13, 2020 | |
| 5 | NucleoSpin Dx Virus | Macherey-Nagel GmbH & Co. | 50T/Cat. No. 740895.50 | 100% | 100% | 100% | 100% | May 13, 2020 | |
| 6 | NucleoSpin Virus | Macherey-Nagel GmbH & Co. | 10preps/Cat. No. 740983.10 50preps/Cat. No. 740983.50 250preps/Cat. No. 740983.250 |
100% | 100% | 100% | 100% | April 27, 2020 | |
| 7 | GenAmplify Viral RNA Purification kit | Manila HealthTek, Inc., Philippines | 50T/Cat. No. GA-RNA050 | 100% | 100% | 100% | – | May 5, 2020 | |
| 8 | High Pure Viral RNA | Roche Diagnostics | – | 100% | – | – | – | ||
| 9 | GeneAid Viral Nucleic Acid Extraction kit II | Geneaid Biotec Ltd. | 50preps/Cat. No. VR050 | 96.20% | 96.20% | 92.30% | May 19, 2020 | ||
| 10 | Biospin Virus DNA/RNA Extraction kit | Hangzhou Bioer Technology Co. Ltd. | 50T/Cat. no. BSC77SI 100T/Cat. no. BSC77MI |
100% | 100% | 96% | 100% | May 19, 2020 | |
| 11 | RNA/DNA Purification kit (Spin Column) | Guangzhou DaTe Bioengineering Technology, Co. Ltd. | 48T/Cat. no. DTTQ00101 | 100% | 100% | 93% | 100% | May 25, 2020 | |
| 12 | ReliaPrep™ Viral Total Nucleic Acid Purification Kit | Promega Corporation | 250preps/Cat. no. AX4820 | 100% | 100% | 100% | 100% | May 25, 2020 | |
| 13 | DIAKEY REALkey Viral DNA/RNA Prep Kit | Shin Jin Medics Inc | 100preps/Cat. no. DP01 | 100% | 100% | 100% | 100% | April 28, 2020 | |
| 14 | (XABT) XABT Nucleic Acid Extraction Kit | Beijing Applied Biological Technologies Co. Ltd. (XABT) | 48 preps/ Cat. # CN80334 | 100% | – | – | – | April 16, 2020 | |
| 15 | BeaverBeads™ Viral DNA/RNA Kit | Beaver Biomedical Engineering Co. Ltd. | 20 preps/ Cat no. 70406-20 | – | – | – | 84.30% | May 6, 2020 | |
| 16 | MGI Nucleic Acid Extraction Kit | Wuhan MGI Tech Co., Ltd. (Wuhan, China) | 1728 preps/ Item no. 1000020261 | – | – | 100% | 100% | May 18, 2020 | |
| 17 | Mag-bind RNA Extraction kit | Maccura Biotechnology Co. Ltd. | 32preps/Cat. No. GN7101907 48preps/Cat. No. GN7102903 |
– | 92.10% | 90.20% | – | June 17, 2020 | |
| 18 | Nucleospin RNA Virus | – | 250preps/Cat. No. 740956.250 | 100% | 100% | 100% | 100% | June 17, 2020 | |
| 19 | GF-1 Viral Nucleic Acid Extraction Kit | Vivantis Technologies | 25preps/Cat. No. GF-RD-025 50preps/Cat. No. GF-RD-050 100preps/Cat. No. GF-RD-100 |
88.30% | 83.30% | 94.40% | – | June 24, 2020 | |
| 20 | GenAmplify™ Viral RNA Purification Kit (GA-RNA100) (version 2) | Manila HealthTek, Inc., Philippines | 100 preps/ GA-RNA100 | – | – | 96.61% | 96.61% | June 8, 2020 | |
| 21 | abGenixTM Automated Nucleic Acid Purification System | AITbiotech Pte LT | 64 preps/Ref No. 800811_C (Version 3.1) | 96.67% | – | – | 98.33% | September 30, 2020 | |
| 22 | Genolution NX-48S Viral NA Kit (VN143) | Genolution Inc (Seoul, South Korea) | 24 preps/ Cat No: BC#5796 (NX-48S Extraction kit) Cat No: BC#5821 (Nextractor Equipment) Lot No: CVN143-201023 | 98.25% | – | – | 51.78% | December 2-7, 2020 | |
| 23 | Maxwell® HT Viral TNA Kit | Promega Corporation | 384 preps Cat. No. AX2340 | – | – | – | – | 100% | December 2-7, 2020 |
| 24 | NucleoMag® Virus | Macherey-Nagel GmbH & Co. | 96 preps Cat. No. 744800.1 | – | – | – | – | 100% | November 17, 2020 |
| 25 | MagaBio plus virus DNA/RNA Extraction and Purification II | Hangzhou Bioer Technology Co., Ltd, Bioflux | Cat No. BSC8M1E 48 preps | 100% | – | – | 90% | December 7-15, 2020 | |
| 26 | Zybio Nucleic Acid Extraction Kit (Magnetic Bead Method) | Zybio Inc., China | Product no. B200-16 32 preps | 100% | 100% | March 8-12, 2021 | |||
Results of RITM evaluations do not, in any way or form, represent a Certificate of Product Registration or Certificate of Authorization issued by the Philippine Food and Drug Administration (FDA).
The Institute is making this information available for public good and does not serve to endorse companies, manufacturers, or product brands for commercial purposes.
