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FIND evaluations of SARS-CoV-2 molecular tests

Two rounds of evaluation for SARS-CoV-2 molecular tests were conducted.

One in 2020, for manual open assays and near point-of-care (POC) platforms and a second one in 2023 for near-POC platforms with multiplexing capacity.

2022-23 evaluations
2020 evaluations

2022-23 evaluations

In February 2022, FIND launched an expression of interest (EOI) for test developers interested in having their SARS-CoV-2 point-of-care (POC) molecular platforms evaluated using a standardized, independent protocol.

Read the protocol

Three POC molecular SARS-CoV-2 assays were selected through a scoring system taking into consideration:

  • supplier-reported analytical performance
  • supplier-reported clinical performance and size of the related study population/number of COVID-19 positive cases
  • ease of use of the test (instrument characteristics, sample type)
  • manufacturing and distribution capacity (especially related to the ability of the company to access LMICs market)
  • regulatory status – products with approval from stringent regulatory bodies such as FDA EUA or WHO EUL are scored higher than CE-IVD self-reported tests which are in turn scored higher than RUO tests.

Results of the evaluations are presented in the table below.

CompanyAssayPlatformCountry of manufacturerRegulatory statusEvaluation statusEvaluation results
SD BIOSENSOR, INC.STANDARD™ M10 SARS-CoV-2 testSTANDARD™ M10 PlatformRep. of KoreaKorea MFDS; Brazil ANVISA; CE-IVDCompletedResults

Switzerland
Uniogen OyGenomEra® SARS-CoV-2, Flu A/B + RSV 2.0 assayGenomEra® CDX SystemFinlandCE-IVDCompletedResults

Uganda
Wondfo Biotech Co. LtdU-Card Dx – 2019-nCoV/Flu TestU-Card Dx InstrumentPR ChinaCE-IVDCompletedResults

United Kingdom
Last update: 20 December 2023

2020 evaluations

In February 2020, FIND launched an expression of interest (EOI) for test developers of in vitro diagnostics (IVDs) that detect SARS-CoV-2 nucleic acid (molecular tests) to participate in independent evaluation studies. Over 200 submissions were received and applications were reviewed according to the following scoring criteria (Table 1).

Table 1: Scoring criteria
Max score
Limit of detection3
Regulatory status2
Type of organization1
Quality management system1
Other products available in low- and middle-income countries3
TOTAL10

FIND conducted independent evaluations at the University Hospitals of Geneva (HUG) to verify the limit of detection (LOD) – as reported by the manufacturers – and the clinical performance of 22 manual molecular test kits in comparison to an in-house PCR protocol that was optimized based on the Tib Molbiol assay. The LOD analysis was performed using cultured viral stocks from a clinical isolate from Switzerland that was quantified using an E gene standard. The clinical performance analysis was conducted on extracted samples from individuals suspected to have COVID-19, 50 of which were reference PCR positive and 100 of which were reference PCR negative. Data are summarized in Table 2.

Additionally, a limited clinical performance evaluation of the Cepheid Xpert Xpress SARS-CoV-2 assay was also performed at HUG. A second collaborating site, the Translational Health Science and Technology Institute (THSTI) conducted a similar limited clinical performance evaluation of the Molbio TrueNat SARS-CoV-2 assay. Both studies were performed using frozen, stored respiratory samples from COVID-19 suspects. Results on the performance of these automated near-POC assays are shown in Table 3.

COVID-19 molecular assay evaluation protocol

Read the protocol
Table 2: Results for 22 manual (open) molecular tests evaluated at HUG
CompanyProduct nameProduct numberGene target Verified LOD (copies / reaction) Avg Ct (lowest dilution 10/10) Clinical sensitivity (50 positives)Clinical specificity*
(100 negatives)		Lot No.PCR platform**Supplier recommended Ct cut-off
1.altona DiagnosticsRealStar®
SARS-CoV-2
RT-PCR Kit 1.0		821003/821005E1–1035.4592%
(95%CI:
81, 97)		100%
(95%CI:
96, 100)		023567BioRad CFX96 deep wellNone;
any signal can be considered positive
S1–1035.9992%
(95%CI:
81, 97)		100%
(95%CI:
96, 100)
2.Atila BioSystems Inc.Atila iAMP
COVID-19 Detection (isothermal detection)		iAMP-COVID-100-RUOORF1ab50–100N/A100%
(95%CI:
93, 100)		99%*
(95%CI:
95, 100)		COVID20200320BioRad CFX96 deep wellAny signal is considered positive (isothermal)
N1–10N/A100%
(95%CI:
93, 100)		100%
(95%CI:
96, 100)
3.Beijing Wantai Biological Pharmacy Enterprise Co. LtdWantai
SARS-CoV-2
RT-PCR Kit		WS-1248ORF1ab1–1036.20100%
(95%CI:
93, 100)		100%
(95%CI:
96, 100)		nCoVP20200305BioRad CFX96 deep well≤40
N1–1037.12100%
(95%CI:
93, 100)		100%
(95%CI:
96, 100)
4.BGI Health (HK) Co. LtdReal-time Fluorescent
RT-PCR kit for detection 2019-nCOV (CE-IVD)		MFG030010ORF11–1032.43100%
(95%CI:
93, 100)		99%*
(95%CI:
95, 100)		6220200305Roche LightCycler 480≤38
5.bioMérieux SAARGENE®
SARS-COV-2
R-GENE®[b]		423720
(CE-IVD)
423717 (RUO)		N10–5036.44100%
(95%CI:
93, 100)		100%
(95%CI:
96, 100)		1007989610
1007947520		BioRad CFX96 deep wellAny signal considered as positive
RdRP10–5032.4496%[a]
(95%CI:
87, 99)		100%
(95%CI:
96, 100)
6.Bioneer Corporation

AccuPower®
SARS-CoV-2 Real-Time

RT-PCR Kit		SCV-2122E10–5035.85100%
(95%CI:
93, 100)		100%
(95%CI:
96, 100)		200931EBioRad CFX96 deep well<38
RdRP10–5036.18100%
(95%CI:
93, 100)		100%
(95%CI:
96, 100)
7.Boditech Med. Inc.ExAmplar COVID-19

real-time
PCR kit (L)		UFPK-4E10–5034.9100%
(95%CI:
93, 100)		100%
(95%CI:
96, 100)		WLQCB02LBioRad CFX96 deep well≤42
RdRP50–10033.4690%
(95%CI:
79, 96)		100%
(95%CI:
96, 100)
8.CerTest Biotec S.L.VIASURE SARS-CoV-2 Real Time PCR Detection KitVS-NC0112L
VS-NC0212L		ORF1ab10–5035.1698%
(95%CI:
90, 100)		100%
(95%CI:
96, 100)		NCO212L-023BioRad CFX96 deep well<40
N1–1035.46100%
(95%CI:
93, 100)		100%
(95%CI:
96, 100)
9.DAAN Gene Co. Ltd of Sun Yat-Sen UniversityDetection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing)DA0930-DA0932ORF11–1038.76100%
(95%CI:
93, 100)		96%*
(95%CI:
90, 98)		2020007Roche LightCycler 480≤40
N1–1036.97100%
(95%CI:
93, 100)		98%*
(95%CI:
93, 99)
10.EUROIMMUN AGEURORealTime SARS-CoV-2[c]MP 2606-0425ORF1ab/N1–1037.88100%
(95%CI:
93, 100)		98%*
(95%CI:
93, 99)		I200320ALLight Cycler 480 IIAny signal considered positive
11. GeneFirst LtdThe Novel Coronavirus (2019-nCoV) Nucleic Acid Test KitMPA-COVID19ORF11–1035.45100%
(95%CI:
93, 100)		99%*
(95%CI:
95, 100)		00072BioRad CFX96 deep well≤37.0 positive;

37-40 indeterminate; >40 negative
N1–1036.7298%
(95%CI:
90, 100)		100%
(95%CI:
96, 100)
12.KH Medical Co. LtdRADI
COVID-19 Detection Kit		RV008S1–1037.94100%
(95%CI:
93, 100)		100%
(95%CI:
96, 100)		V008.200202BioRad CFX96 deep well≤40
RdRP10–5036.74100%
(95%CI:
93, 100)		100%
(95%CI:
96, 100)
13.PerkinElmer Inc.PerkinElmer® SARS-CoV-2 Real-time
RT-PCR Assay[c,d]		SY580N1–1039,43100%
(95%CI:
93, 100)		99%*
(95%CI:
95, 100)		8220200303BioRad CFX96 deep well≤42
ORF11–1038,99100%
(95%CI:
93, 100)		100%
(95%CI:
96, 100)
14.Primerdesign Ltd

Coronavirus COVID-19 genesig®
Real-Time PCR assay[c]		Z-Path-COVID-19-CERdRP1–1036.7100%
(95%CI:
93, 100)		100%
(95%CI:
96, 100)		JN-02780-0009LightCycler 480Any signal regarded as positive
15.QuantumDxQuantuMDx SARS-CoV-2 RT-PCR Detection AssayQ22003Orf1, N, S1–1036.8100%
(95% CI:
92, 100)		100%
(95% CI:
96, 100		P01100BioRad CFX96 deep well≤40
16.R-Biopharm AGRIDA®GENE SARS-CoV-2 RUOPG6815RUOE1–1037.99100%
(95%CI:
93, 100)		100%
(95%CI:
96, 100)		21120NBioRad CFX96 deep wellNone;
any signal can be considered positive
17.Sansure Biotech Inc.Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)[e]S3102EORF110–5035.16100%
(95%CI:
93, 100)		100%
(95%CI:
96, 100)		2020007ZCThermofisher Quantstudio 5≤40
N10–5034.96100%
(95%CI:
93, 100)		95%*
(95%CI:
89–98)
18.SD Biosensor Inc.STANDARD M nCoV
Real-Time Detection Kit		M-NCOV-01E1–1037.43100%
(95%CI:
93, 100)		97%*
(95%CI:
92, 99)		MNC00120005Roche LightCycler 480≤41
ORF11–1036.99100%
(95%CI:
93, 100)		99%*
(95%CI:
95, 100)
19.Seegene Inc.Allplex™
2019-nCoV Assay		RP10244Y
RP10243X		E1–1033.3100%
(95%CI:
93, 100)		100%
(95%CI:
96, 100)		RP4520C24BioRad CFX96≤40
N1–1036.74100%
(95%CI:
93, 100)		100%
(95%CI:
96, 100)
RdRP1–1034.73100%
(95%CI:
93, 100)		100%
(95%CI:
96, 100)
20.Shanghai Kehua Bio-Engineering Co. LtdKHB Diagnostic kit for
SARS-CoV-2 Nucleic Acid (Real-time PCR)		KH-G-M-574-48ORF11–1030.39100%
(95%CI:
93, 100)		100%
(95%CI:
96, 100)		20037410BioRad CFX96 deep wellMore than two targets detected and curve is of S shape
N1–1032.95100%
(95%CI:
93, 100)		100%
(95%CI:
96, 100)
E1–1031.72100%
(95%CI:
93, 100)		100%
(95%CI:
96, 100)
21.ThermoFisher ScientificTaqPath™ COVID-19
CE-IVD
RT-PCR Kit[f]		A48067ORF1ab;
S
N		1–10NA100%
(95%CI:
93, 100)		100%
(95%CI:
96, 100)		2225262Quantstudio 5Not Applicable (Automated software interpretation)
22.Vela DiagnosticsViroKey™ SARS-CoV-2 RT-PCR Test[c]300682RdRP10–5030.9594%
(95%CI:
84, 98)		100%
(95%CI:
96, 100)		1000000597BioRad CFX96 deep well≤40
ORF11–1035.57100%
(95%CI:
93, 100)		100%
(95%CI:
96, 100)
Tib Molbiol/Roche DiagnosticsModularDx Kit SARS-CoV (COVID19) E-gene (Tib Molbiol) + LightCycler Multiplex RNA Virus Master (Roche)53-0776-96
6754155001		E1–1033.34100%
(95%CI:
93, 100)		100%
96, 100)		48202019
48274100		Roche LightCycler 480Define the
cut-off 2–4 cycles higher than observed Cp value for

10 copies
* Clinical specificity: Further investigation is needed to determine if apparent false positives are truly false positives or whether they are due to a false negative reference standard result
** PCR platform: All products were evaluated on a PCR platform recommended by the supplier, listed in this table. Each test can be performed on other PCR systems, detailed in the product’s instructions for use.
[a] The two false negative samples tested positive with the second PCR (PCR 2) that targets E gene of SARS, SARS-COV-2 and/or SARS-like coronaviruses.
[b] Samples for both analytical and clinical analyses were from already-extracted specimen, therefore the methods varied from those recommended by the supplier as the internal control was not included.
[c] Samples for both analytical and clinical analyses were from already-extracted specimen, therefore the methods varied from those recommended by the supplier as the internal control was added to the master mix.
[d] Evaluation procedure varied from recommended protocol. In order to achieve the recommended sample input volume, a 2.5 fold dilution of the samples was used.
[e] Sansure claims a lower LOD of 6.4 cp/rxn, which has been independently verified.
[f] Evaluation procedure varied from recommended protocol as source material was already-extracted RNA; extracted MS2 control was added directly to the master mix.
Table 3: Results for evaluation of two near-POC automated tests
CompanyProduct nameProduct numberGene target Clinical sensitivity (50 positives) Clinical specificity*
(100 negatives)		Comparator test
Cepheid Inc.Xpert® Xpress
SARS-CoV-2		XPRSARS-COV2-10N2100%
(95%CI:
92,100)		99% *
(95%CI:
95, 100)		Roche Cobas ® SARS-CoV-2
N = 44 positive
N = 100 negative
E97.7%
(95% CI:
88, 100)		100%
(95%CI:
96, 100)
Molbio Diagnostics Pvt LtdTrueNat
SARS-CoV-2[1]		601410020E+RdRP[2]98%
(95% CI:
90.98)		96% *
(95% CI:90,98)		altona Diagnostics (n=86) /LabGun™ (n=64) and/or Seegene, Inc. (n=12)
N = 51 positive
N = 111 negative
601420050
* Clinical specificity: Further investigation is needed to determine if apparent false positives are truly false positives or whether they are due to a false negative reference standard result
[1] Note: evaluation performed at THSTI

[2] RdRP is only used as a reflex test; the results are for combined E+RdRP positives

More information

For questions relating to the evaluation of molecular tests, please contact our Emerging Threats team.