LumiraDx

The LumiraDx™ SARS-CoV-2 and Flu A/B assay serves as a rapid, cost-effective triage tool in emergency settings, offering high specificity and the ability to identify patients with high viral loads most likely to benefit from immediate intervention. While its sensitivity is lower than molecular PCR and the SARS-CoV-2 component may require laboratory confirmation during low prevalence, the platform significantly outperforms multiplex molecular tests in terms of speed and cost. By providing automated, interfaceable results in minutes, this technology facilitates real-time infection control and reduces operational pressure on acute hospital settings during peak respiratory seasons.

"POCT CRP influenced physicians' prescribing decisions, particularly when CRP levels exceeded 20 mg/L. However, without structured integration into clinical algorithms, its use alone did not reduce overall antibiotic use. Physician training and adherence to CRP-based guidance are essential to optimize the benefits of POCT CRP in antimicrobial stewardship."

"EQA schemes can provide valuable data to inform participants about weaknesses in their testing process or methods and support ongoing assay evaluations for regulatory approval or post-market surveillance."

"This study shows the importance of independent evaluations for assessing the performance of Hb A1c POC devices [A1CNow+, A1C EZ 2.0, A1Care, Afinion 2, Cobas b101, GPP-100, LumiraDx (7 min & 5 min), PixoTest, Quo-Lab, Quo-Test, Hb A1c 501, Spinit, Greencare A1c, Atellica DCA, On Call MultiPro, Lyofia, CareBuddy Multi Analyzer and TD-4611]. The analytical performance of the devices was very poor overall, with 74% not meeting both IFCC and NGSP criteria. These evaluations were performed under ideal conditions; performance may worsen further when used in a clinical setting."

"Innovance and LumiraDx assays had similar safety in excluding PE by AADD compared with VIDAS. STA Liatest and Tina-quant classified a higher proportion of patients with a negative AADD, among whom 3 and 5 had PE, respectively."

This study evaluated ten SARS-CoV-2 rapid diagnostic tests across Nigeria, finding that while antigen-based kits [LumiraDx SARS-CoV-2 Ag, Abbott Panbio COVID-19 Ag, Lifotronic SARS-CoV-2 Antigen, MP Rapid SARS-CoV-2 Antigen Card, Mologic COVID-19 Antigen Rapid Diagnostic Test, SGTi-flex COVID-19 Ag] outperform antibody tests [SGTi-flex COVID-19 IgM/IgG, SD Biosensor COVID-19 IgM/IgG Combo, RightSign COVID-19 IgG/IgM Rapid Test Cassette, Genrui Novel Coronavirus (2019-nCoV) IgG/IgM test kit], their overall sensitivity remains significantly below WHO standards. Among 1,310 participants, Lumira Dx showed the highest sensitivity (61.4%), while MP SARS and Panbio achieved the highest specificity (98.5%). While these RDTs are reliable for confirming positive cases due to high specificity, their low sensitivity limits their effectiveness in ruling out infections, especially in asymptomatic individuals. The authors conclude that Nigeria needs locally developed diagnostics tailored to its specific environmental factors and circulating viral strains.

"The analytical performance and user-friendliness of POCT-CRP devices [QuikRead go easy, LumiraDx, cobas b 101 and Afinion 2] varies among manufacturers, emphasizing the need for quality assurance supervised by a central laboratory."

"Clinical performance of the POC D-dimer devices [Exdia TRF Plus, AFIAS-1, Standard F200, LumiraDx™ and Hipro AFS/1®] for predicting a VTE in low-risk patients was comparable to that of a laboratory-based assay. However, our results indicate that the finger stick feature of certain devices should be further improved."

This study compared the analytical performance of four COVID-19 rapid tests (Abbott BinaxNOW/Panbio, SD Biosensor, and LumiraDx) using a standardized benchmarking panel. The researchers evaluated nucleocapsid (N) and spike (S) antigen concentrations against RT-PCR genome equivalents across recombinant proteins, inactivated virus, and clinical specimen pools. The results confirmed that N antigen is 10 times more abundant than S antigen per genome, making it the superior diagnostic target. While sensitivity varied between 21 and 102 pg/mL, all tests performed most effectively on clinical specimen pools, proving that this benchmarking framework allows for a rapid, direct comparison of RDT sensitivity across different manufacturers and viral variants.

This study evaluated four SARS-CoV-2 antigen tests (LumiraDx, BD Veritor, CareStart, and Oscar Corona) by comparing them to viral culture and RT-qPCR viral load quantification. The findings show that antigen tests, particularly the microfluidic LumiraDx (90% sensitivity), are highly effective at predicting the presence of culturable virus when viral loads exceed 1.000.000 copies/mL. Ultimately, the researchers conclude that these rapid tests are a reliable tool for ruling out immediate infectivity at the time of sampling. Because they accurately detect peak viral shedding, they provide a practical, low-cost alternative to PCR for real-time screening and isolation decisions.

"The near immediate time-to-result for antigen tests [ STANDARD Q COVID-19 Ag Nasal and Saliva tests, the SARS-CoV-2 Ag Test (LumiraDx™ Limited, United Kingdom), and the SalivaDirect™ protocol (Yale School of Public Health, United States)] significantly offsets lower analytical sensitivity in settings where RT-PCR results are delayed or unavailable."

"In summary, new RATs [Passed: Biosynex COVID-19 Ag+, Biosynex COVID-19 Ag BSS, Newgene COVID-19 Antigen Detection Kit, Clungene COVID-19 Rapid Antigen Test Cassette, Exdia COVID-19 Ag, Fluorecare® SARS-CoV-2 Spike Protein Test Kit, LumiraDx SARS-CoV-2 Ag, Lysun SARS-CoV-2 Antigen, Medicovid-AG® Test, MEDsan® SARS-CoV-2 Antigen Rapid Test, MP COVID-19 Antigen Rapid Test, NowCheck® COVID-19 Ag Test, Test rapide AMP SARS-CoV-2 Ag, The BD Veritor™ System, Willi Fox COVID-19 Antigen Test®; Failed: Acro COVID-19 Antigen test, Clinitest® Rapid COVID-19 Antigen Test, Prima Lab COVID-19 Antigen Rapid Test, Biozek COVID-19 Antigen Rapid Test Cassette, GenBody COVID-19 Ag, Genedia W COVID-19 Ag, Humasis COVID-19 Ag Test, Lansionbio® COVID-19 Antigen Test Kit, Hotgen Novel Coronavirus 2019-nCoV Antigen Test, Realy antigen test, Lepu SARS-CoV-2 Antigen Rapid Test, UNscience SARS-CoV-2 Antigen Rapid Test Kit, SGTi-flex COVID-19 Ag, VivaDiag™ SARS-CoV-2 Rapid Ag Test, Wondfo SARS-CoV-2 Antigen Test] should be properly evaluated with a standardized protocol, sufficient large sample, declaration on the sample origin, describing the sample material type, symptomatic or asymptomatic patients, and the time since symptoms onset. Overall, the poor sensitivity of multiple tests highlights the general problems with RATs - in critical situations SARS-CoV-2 specific RT-PCR should be used."

"LumiraDx CRP readouts on fingerprick blood and serum correlate closely. Stored serum can be used for LumiraDx CRP measurement. High sensitivity methods increase the proportion of people who screen false-positive."

"The LumiraDx® NT-proBNP POCT device demonstrates strong potential for HF management by combining rapid results, user-friendly operation, and sampling versatility. While biases at higher NT-proBNP levels warrant further standardization, this system represents a practical tool for decentralized HF care."

"The LumiraDX™ POCT device demonstrates sufficient accuracy in measuring CRP levels from finger prick capillary blood. The availability of this technology across community healthcare settings will improve the assessment of infection and support more precise antibiotic prescribing."

"The LumiraDx INR Test showed a good performance compared to laboratory-based testing and provided opportunity for rapid and patient-centric care. Owing to an increasing positive bias for INR > 3.5, confirmation with laboratory INR measurements may be required."

"This study showed that LumiraDx™ test is reliable for SARS-CoV-2 diagnosis in patients with mild-to-moderate SARS-CoV-2 symptoms. This finding confirms the efficacy of rapid antigen tests in monitoring vulnerable individuals during the current post-vaccination era. When compared with the RT-PCR, LumiraDx™ test effectively quantitatively distinguishes between FN and TN cases, as well as FP and true TP tests, despite inaccuracies in qualitative results."

"The LumiraDx SARS-CoV-2 and Flu A/B Test shows a high agreement with the reference RT-PCR tests while simultaneously detecting and differentiating between SARS-CoV-2 and influenza A/B."

"In our setting, the COVIOS Ag-RDT did not meet WHO requirements. Nasal swab-based Ag-RDTs for SARS-CoV-2 detection constitute a viable and accurate diagnostic option in resource-poor settings."

"This rapid, high-sensitivity test can be used to screen asymptomatic patients for acute SARS-CoV-2 infection in clinic- and community-based settings."

"The diagnostic performance of the LumiraDX SARS-CoV-2 Antigen Test would allow the conclusion that it may be considered a cost-effective, much handier alternative, with only a slightly less reliable outcome than molecular testing for rapid preliminary screening of acute SARS-CoV-2 infections, especially in clinical specimens bearing high viral loads. Notably, a careful Bayesian-oriented approach should always be carried out, discouraging the deployment of these tests in contexts where the prevalence of COVID-19 is low and there are no reported contacts with positive cases. In such cases, the use of molecular assays is still almost unavoidable."

"The LumiraDx™ assay showed excellent analytical sensitivity, exclusivity and clinical specificity with good clinical sensitivity using supervised NMT self-sampling."

"In conclusion, the above-described characteristics make LumiraDxTM tests suitable for large-scale mass testing and SARS-CoV-2 containment strategies, integrating social distancing, masks usage, serial antigen screenings, and contact tracing. Moreover, the tests are useful for frontline screening in the emergency department to guarantee a fast-track path toward COVID-wards. However, in this setting, the risk of misrecognition of patients with active COVID-19 still exists, and the need for confirmatory real time RT-PCR in symptomatic subjects who test as antigen-negative should not be amended. Given the current availability of different types of COVID-19 testing strategies, LumiraDxTM may not have an antagonist, but a complementary role with the real time RT-PCR test in the pandemic response. Additionally, in accordance with the prevalence of infection in each population and risk mitigation strategies, a two-step approach may be considered and based on country capacity and cost-effectiveness. Furthermore, it may be time- and cost-effective for clinical microbiology laboratories, both to avoid diagnostic delays due to overload and to ensure a high-quality activity for the management of all the other daily microbiological activities."

This study demonstrates that in resource-limited settings like Mozambique, Ag-RDTs are a highly cost-effective alternative to RT-PCR, costing approximately three times less per test ($11.60 vs. $39.20). Medical supplies emerged as the primary cost driver, accounting for over 50% of total expenses, while the impact of personnel and overhead costs remained secondary. The findings suggest that the most effective way for governments in LMICs to reduce testing expenditures is to focus on lowering the cost of medical supplies rather than shifting labor cadres. Ultimately, integrating affordable Ag-RDTs into national screening strategies provides a sustainable and efficient pathway for managing pandemic diagnostic needs in resource-scarce environments.