metricas
covid
Buscar en
Enfermedades Infecciosas y Microbiología Clínica (English Edition)
Toda la web
Inicio Enfermedades Infecciosas y Microbiología Clínica (English Edition) A systematic review on rapid antigen test devices for SARS-CoV-2 in nursing home...
Información de la revista
Vol. 40. Núm. 7.
Páginas 412-414 (agosto - septiembre 2022)
Compartir
Compartir
Descargar PDF
Más opciones de artículo
Vol. 40. Núm. 7.
Páginas 412-414 (agosto - septiembre 2022)
Letter to the Editor
Acceso a texto completo
A systematic review on rapid antigen test devices for SARS-CoV-2 in nursing homes: Useful, but handle with care
Una revisión sistemática sobre los test rápidos de antígenos para la detección del SARS-CoV-2 en centros residenciales: útiles, pero deben manejarse con cuidado
Visitas
198
Matteo Ricco
AUSL – IRCCS di Reggio Emilia, Servizio di Prevenzione e Sicurezza negli ambienti di Lavoro (SPSAL), Reggio Emilia, RE, Italy
Este artículo ha recibido
Información del artículo
Texto completo
Bibliografía
Descargar PDF
Estadísticas
Material adicional (1)
Texto completo
Dear Editor,

The COVID-19 pandemic has disproportionately affected Nursing homes (NHs), with mortality rates largely exceeding those of the general population, particularly during the first wave.1,2 A recent study from England and Wales has estimated an 18-fold difference in mortality rates when figures were compared to the pre-pandemic time period, but this is a likely an underestimate given the low levels of testing in NHs, particularly when nasal swabs with subsequent Real-Time quantitative polymerase chain reaction (RT-qPCR) represented the only validated diagnostic items.2

As recently pointed out by Domínguez Fernandez et al.,3 rapid antigen tests (RAT), with their reduced costs and turnaround times,4 could significantly speed and scale up diagnoses, benefiting residents’ and workers’ safety. However, available evidence appears far more controversial. We specifically performed a systematic review and meta-analysis on RAT in NHs according to PRISMA guidelines (see Annex 1A for the detailed search strategy),5 being able to retrieve 5 studies (Table 1), for a total of 1327 paired samples RAT vs. RT-qPCR from residents of NHs, three of them from Spain.3,6–9

Table 1.

Summary of the studies included in the present meta-analysis.

Reference  Characteristics of the samples  Commercial test  No. of samples  TP  FP  FN  TN  Se.  Sp.  PPV  PNV  Accuracy  Cohen's Kappa 
Paap et al., 20216  Three NHs organizations in the Netherlands; single swab (December 1st, 2020, to March 31st, 2021)  Aptima® SARS-CoV-2 Assay+Lightcycler 480 from Roche diagnostics  461  27  25  26  383  50.9%  93.9%  51.9%  93.6%  88.9%  0.452 
Escrivá et al., 20217  Seven NHs belonging to the Health Department of Consorcio Hospital General Universitario de Valencia (November–December, 2020)  Panbio COVID-19 Rapid Test Device  448  99  18  331  84.6%  100%  100%  94.8%  96.0%  0.890 
Diez Flecha et al., 20218  One NH from the Spanish State of Leon after the emergence of a single case (November 24–25th, 2020)  Panbio COVID-19 Rapid Test Device  55  36  13  73.5%  100%  100%  31.6%  76.4%  0.377 
Dominguez Fernández et al., 20223  One NH from the Spanish State of Galicia (September, 2020)  Panbio COVID-19 Rapid Test Device  30  19  10  95.0%  100%  100%  90.9%  96.7%  0.927 
McKay et al., 20219  Serial facility-wide testing in a NH from Georgia (USA) (October, 22–November 3rd, 2020)  BinaxNOW  333  68  30  227  69.4%  96.6%  89.5%  88.3%  88.6%  0.706 
POOLED  –  –  1327  249  33  88  957  75.8%  99.0%  88.3%  91.6%  90.9%  0.670 
Only asymptomatic  –  –  311  70  34  200  67.3%  96.6%  90.9%  85.5%  86.8%  0.683 
Only cases with cycle threshold25  –  –  31  31  25.8%  –  –  –  –  – 

Notes: NH=nursing home; TP=true positive; FP=false positive; FN=false negative; TN=true negative; Se.=sensitivity; Sp.=specificity; PPV=predicted positive value; PNV=predicted negative value; Cohen's Kappa values should be interpreted as follows: 0.0–0.20 no agreement, 0.21–0.39 minimal agreement, 0.40–0.59 weak agreement, 0.60–0.79 moderate agreement, 0.80–0.90 strong agreement, >0.90 almost perfect agreement.

Overall, RT-qPCR detected 337 SARS-CoV-2 positive cases (25.4%), with a pooled sensitivity of 75.8% (95% Confidence Interval [95%CI] 61.0–86.2) that was affected by substantial heterogeneity (I2=82%, p<0.01), and a pooled specificity of 99.0% (95%CI 89.3–99.9) (see Annex 1B for details). Two studies included estimates of viral replication,6,8 while other two studies reported RAT performances by symptom status.8,9 Even though Escrivá et al.7 included both symptom and viral activity statuses, reporting strategy impaired their inclusion in subgroup estimates. When sensitivity was calculated for samples characterized by cycle threshold values25, an overall estimate of 25.8% was calculated, that increased to 67.3% in asymptomatic individuals irrespective of their viral replication status.

Diagnostic agreement, reported by means of Cohen's Kappa, ranged between 0.377 (95%CI 0.352–0.401)8 and 0.927 (95%CI 0.909–0.944),3 with a pooled estimate of 0.670 (95%CI 0.452–0.889), suggesting a moderate agreement despite the substantial heterogeneity (I2=100%, p<0.01). Diagnostic Odds Ratio (DOR) was estimated in 95.552 (95%CI 16.125–565.859), i.e. the OR for the positive result among residents with SARS-CoV-2 was approximately 96 times higher than the OR for positive results among persons without SARS-CoV-2. Summary Receiver Operating Characteristic (SROC) Curve (Annex 1C) was estimated through a maximum likelihood estimation model (REML), and a fixed model. Not only both curves were quite asymmetrical, suggesting a substantial heterogeneity among retrieved studies, but the substantial difference between the curves suggested that a substantial threshold effect may present, i.e. higher content of viral antigen may lead to increased identification of positive cases by RAT.

In other words, real-world estimates suggest that actual reliability of RAT may be quite far from optimal, particularly for non-seriated testing strategy. As acknowledged by Dominguez-Fernández et al.,3 in cases characterized by high viral load, RAT may be quite reliable,6,8 but they exhibited substantial lack of sensitivity when employed in individuals that exhibit low viral replication. Indeed, RAT may be quite unreliable when employed to screen earlier stages of SARS-CoV-2 infections, or in individuals who, because of their even transitory lack of symptoms, may actively spread the infection not only among other residents, but also in NH workers failing to cope with appropriate preventive measures.1,2 As a consequence, as suggested by McKay et al.,9 early and frequent referral to RAT rather than a single and synchronous sampling campaign may be quite effective in identifying individuals with the greatest potential to transmit the virus.

In summary, as RAT are relatively easy to use, produce results in minutes, and do not require expensive laboratory instruments, they can provide actionable results, particularly during outbreaks, but require a rational and specifically tailored use. On the contrary, as previously stressed by Escrivá et al.,7 the improper referral to instruments that can be affected by substantial lack of sensitivity may lead to potentially dismal consequences.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Conflict of interest

We declare no competing interest. The facts, conclusions, and opinions stated in the article represent the Authors’ research, conclusions, and opinions, and are believed to be substantiated, accurate, valid, and reliable. However, as this article includes the results of personal researches of the Authors, presenting correspondent, personal conclusions, and opinions, parent employers are not forced in any way to endorse or share its contents and its potential implications.

Appendix A
Supplementary data

The following are the supplementary data to this article:

References
[1]
P. Kierkegaard, M. Micocci, A. McLister, J.S.P. Tulloch, P. Parvulescu, A.L. Gordon, et al.
Implementing lateral flow devices in long-term care facilities: experiences from the Liverpool COVID-19 community testing pilot in care homes—a qualitative study.
BMC Health Serv Res, 21 (2021), pp. 1153
[2]
A. Schultze, E. Nightingale, D. Evans, W. Hulme, A. Rosello, C. Bates, et al.
Mortality among Care Home Residents in England during the first and second wave of the COVID-19 pandemic: an observational study of 4.3 million adults over the age of 65.
Lancet Reg Health – Eur, 14 (2022), pp. 100295
[3]
M. Domínguez Fernández, M.F. Peña Rodríguez, F. Lamelo Alfonsín, G. Bou Arévalo.
Experience with Panbio™ rapid antigens test device for the detection of SARS-CoV-2 in nursing homes.
Enferm Infecc Microbiol Clin, 40 (2022), pp. 42-43
[4]
M. Riccò, P. Ferraro, G. Gualerzi, S. Ranzieri, B.M. Henry, Y.b. Said, et al.
Point-of-care diagnostic tests for detecting SARS-CoV-2 antibodies: a systematic review and meta-analysis of real-world data.
J Clin Med, 9 (2020), pp. 1515
[5]
D. Moher, A. Liberati, J. Tetzlaff, D.G. Altman, D. Altman, G. Antes, et al.
Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement.
PLoS Med, 6 (2009), pp. e1000097
[6]
K.C. Paap, A.M. van Loon, F.M. Koene, L.W. van Buul, S. Jurriaans, M. Smalbrugge, et al.
Clinical evaluation of single-swab sampling for rapid COVID-19 detection in outbreak settings in Dutch nursing homes.
Eur Geriatric Med, (2021),
[7]
B.F. Escrivá, M.D.O. Mochón, R.M. González, C.S. García, A.T. Pla, A.S. Ricart, et al.
The effectiveness of rapid antigen test-based for SARS-CoV-2 detection in nursing homes in Valencia, Spain.
J Clin Virol, 143 (2021), pp. 104941
[8]
C. Diez Flecha, A.M. Rivero Rodríguez, T. Fernández-Villa, P. Fernández García, J.L. Ferreira de Jesús, G. Sánchez Antolín.
Internal validity of a rapid test for COVID-19 antigens in a nursing home.
Semergen, 47 (2021), pp. 332-336
[9]
S.L. McKay, F.A. Tobolowsky, E.D. Moritz, K.M. Hatfield, A. Bhatnagar, S.P. LaVoie, et al.
Performance evaluation of serial SARS-CoV-2 rapid antigen testing during a nursing home outbreak.
Ann Intern Med, 174 (2021), pp. 945-951
Copyright © 2022. Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica
Descargar PDF
Opciones de artículo
es en pt

¿Es usted profesional sanitario apto para prescribir o dispensar medicamentos?

Are you a health professional able to prescribe or dispense drugs?

Você é um profissional de saúde habilitado a prescrever ou dispensar medicamentos