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诊断缺口
猫利什曼病(FeL)在利什曼原虫(L. infantum)流行区,尤其是地中海盆地,日益被认为是一种具有临床相关性的疾病(Pereira and Maia, 2021; Garcia-Torres et al., 2022; Carbonara et al., 2024)。此外,越来越多的流行病学和异体诊断证据表明,感染猫可通过感染具有传播能力的白蛉媒介而参与传播循环(Maroli et al., 2007),尽管其在种群水平上作为储存宿主的重要性尚不如犬那样明确。因此,2015年LeishVet建议强调,对于出现相容的皮肤、眼部、口腔、淋巴结或全身性异常的猫,尤其是在流行区,应考虑FeL(Pennisi et al., 2015)。然而,在这些建议发表十余年后,一个重要的诊断缺口仍然存在:专门为猫开发并验证的快速即时检验血清学检测方法可及性有限。更新的LeishVet建议明确承认了这一局限性,指出目前尚无针对猫利什曼原虫感染的商业化血清学检测经过外部验证并在同行评审期刊上发表,并警告不要假设为犬开发的快速检测在猫中具有诊断准确性(Pennisi et al., 2026)。
近期流行病学证据表明,猫暴露于利什曼原虫(L. infantum)并非罕见。一项纳入来自六个地中海国家2067只猫的多中心研究报告总体血清阳性率为17.3%。收容所或自由放养状态以及猫免疫缺陷病毒感染被确定为危险因素,而血清阳性与体重减轻、淋巴结肿大、牙龈口炎、口腔病变、高球蛋白血症及白蛋白与球蛋白比值降低相关(Carbonara et al., 2024)。
当前的诊断方法包括定量血清学、分子检测、细胞学、组织病理学和免疫组织化学。没有任何单一方法能提供完全的诊断确定性,当临床疑似猫的血清学阴性或弱阳性时,建议进行补充检查(Pennisi et al., 2026)。这些技术中的许多难以整合到即时首诊决策中。分子方法、Western blot(WB)、免疫组织化学和寄生虫培养需要适配的实验室设施、训练有素的人员或特定仪器。细胞学和组织病理学依赖于适当的病变选取,可能需要侵入性采样,而间接荧光抗体试验(IFAT)和酶联免疫吸附试验(ELISA)通常无法在就诊期间提供结果。当临床异常轻微或非特异性时,这些局限性可能延迟FeL的识别。这与犬利什曼病(CanL)形成对比,在犬利什曼病中快速免疫层析试验(ICTs)已广泛纳入常规诊断流程(Villanueva-Saz et al., 2022)。因此,相关问题不仅仅是为什么快速检测在犬中广泛使用而在猫中较少使用,而是犬血清学范式是否适用于猫的感染。
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为什么猫需要物种适配的血清学
暴露于利什曼原虫(L. infantum)的猫和犬不一定产生诊断上等效的抗体反应。在来自同一流行区的自然暴露猫和犬中,当综合考虑血清学、分子和细胞介导免疫标志物时,观察到相似的总体寄生虫暴露或感染频率。然而,犬表现出显著高于猫的抗利什曼原虫(L. infantum)抗体水平,表明免疫反应存在宿主依赖性差异(Priolo et al., 2022)。
在体外以利什曼原虫(L. infantum)感染的猫单核细胞衍生巨噬细胞中,白细胞介素(IL)-2、干扰素(IFN)-γ和肿瘤坏死因子(TNF)-α上调,而IL-4和IL-6保持相对稳定,IL-10表达下降。这种以T辅助1型为主的炎症特征可能有助于部分控制感染,并被认为可能是猫与犬相比临床病程总体较轻的一种解释(Louzada-Flores et al., 2026)。
早期证据也支持猫对利什曼原虫属感染存在物种特异性免疫反应,包括寄生虫特异性细胞介导反应以及可能与犬和人类中所描述的不同的宿主-寄生虫相互作用(Pereira and Maia, 2021)。这些观察表明,猫对利什曼原虫(L. infantum)的免疫反应不应从犬模型外推(Pereira and Maia, 2021; Louzada-Flores et al., 2026)。
在猫利什曼病(FeL)的血清学技术评估中,已有多种诊断方法被描述。在此意义上,未假设存在完美诊断金标准的情况下进行的贝叶斯分析估计,WB 的中位敏感性为 97%,IFAT 为 75%,ELISA 为 70%,相应特异性分别为 99%、97% 和 98%(Persichetti 等,2017)。在西班牙萨拉戈萨外观健康的流浪猫中,阳性率从 IFAT 的 2.2% 和 ELISA 的 2.8% 到 WB 的 14.5% 不等,而定量 PCR 在 5.6% 的猫血液中检测到利什曼原虫(L. infantum) DNA。总体而言,基于血清学和/或分子学证据,15.6% 被认为是感染的,但只有两只动物在所有方法中均为阳性(Alcover 等,2021)。尽管这些结果不能直接外推到具有明显 FeL 的猫,但它们说明了猫感染的识别取决于所选择的诊断平台。
这种诊断异质性的进一步证据来自一项对 166 只收容所猫的研究,其中 ELISA(15%)、IFAT(53.6%)、分子方法(3.6%)和寄生虫学检查(1.8%)获得的检出率明显不同(Silva 等,2023)。尽管这些估计取决于所研究的人群以及所应用的诊断标准和临界值,但方法之间的显著差异进一步表明,单个检测方法不可互换,并支持使用互补的诊断方法(Silva 等,2023)。
因此,抗利什曼原虫抗体检测不应被视为在不同宿主物种之间直接等同。在猫血清学中,抗原选择影响抗体识别,因为不同的利什曼原虫(L. infantum)抗原产生异质且部分互补的血清学特征(Lima 等,2026)。检测化学同样可影响猫样本中的分析性能,如与常规胶体金系统相比,基于乳胶的侧向层析形式实现了更高的灵敏度和检测线强度(Puerta López 等,2026)。免疫球蛋白结合试剂在哺乳动物分类群中也可能表现出物种依赖性亲和力(Villanueva-Saz 等,2026)。然而,抗原选择、检测化学和检测阈值主要应被视为需要猫特异性优化和验证的变量,而非猫与犬血清学之间已确立的内在差异。血清学特异性还可能受到暴露于其他利什曼原虫物种的进一步影响。例如,自然暴露的户外猫中利什曼原虫(L. infantum)与塔伦托利什曼原虫之间的 IFAT 交叉反应构成了额外的诊断挑战,并证明了抗原选择和检测特异性验证在猫血清学中的重要性(Mendoza-Roldan 等,2025)。
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即时检验血清学可增加的价值
即时检验检测的主要价值不在于替代常规实验室诊断,而在于在决策时作为诊断流程的初始步骤提供快速、临床相关的信息。尽管这种方法在犬中常规使用(Maia 和 Campino,2018),但经外部验证、适应猫的即时检验血清学策略尚未在临床实践中确立(Pennisi 等,2026)。对低水平猫抗体反应敏感性不足的 ICT 可能会通过在临床怀疑本已较低的动物中产生阴性结果,从而强化 FeL 罕见的观念。相比之下,适应猫的检测可降低进一步检查的门槛,并改变就诊时的临床推理。
最近的一份临床病例报告支持这一潜力。在一只患有单侧葡萄膜炎的猫中,一种商业抗利什曼原虫(L. infantum)抗体快速检测在血清和房水中呈阳性。随后通过 ELISA、WB、血液和房水 PCR 以及寄生虫分离及分子鉴定为利什曼原虫(L. infantum)支持了感染(González 等,2026)。ICT 并未独立确立诊断;相反,即时的血清学信息被纳入了更广泛的诊断调查中。
在一项涉及 186 份来自家养和非家养物种血清样本的商业 ICT 评估中,所纳入的猫样本中观察到 ICT 与参考血清学分类完全一致。其他分类群,尤其是食草动物,出现了明显的物种依赖性差异,突出了结合物-免疫球蛋白相互作用和物种特异性检测验证的重要性(Villanueva-Saz 等,2026)。最近,一种猫特异性基于乳胶的 ICT 的开发表明,检测化学的优化可显著改善猫的血清学检测。与常规胶体金系统相比,基于乳胶的检测显示出明显更高的灵敏度,同时保持非常高的特异性并改善检测线信号强度(Puerta López 等,2026)。
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猫 ICT 的适当临床作用
猫特异性ICT不应被视为能够独立诊断临床猫利什曼病的单一检测。抗体阳性结果并不能独立确定利什曼原虫(L. infantum)是临床异常的原因,因为暴露或亚临床感染可能与无关疾病共存。同样,具有相容临床症状但血清学阴性或弱阳性的猫仍可能需要分子或寄生虫学检查(Pennisi等,2026)。因此,经过验证的猫ICT的最大价值可能在于作为多模式诊断路径中的一线分诊工具,尤其是在来自利什曼原虫(L. infantum)流行区、表现为相容临床症状和/或相容实验室异常的猫中。即时阳性结果可增强临床怀疑并支持进一步检测,包括定量血清学、分子检测、细胞学或直接寄生虫检测如免疫组化或寄生虫分离。相反,当临床怀疑仍然很高时,阴性结果不应终止诊断检查,应推荐使用额外的确认技术。诊断实用性不仅取决于敏感性和特异性,还取决于目标人群和结果所触发的临床决策。因此,即时检测若能加速识别被低估的鉴别诊断并引导适当的确认性检查,则可能具有价值。
除了在临床疑似病例中的潜在用途外,即时血清学还可能在部分有明显流行病学暴露于利什曼原虫(L. infantum)的表观健康猫中发挥作用,尤其是那些生活在或前往流行区的猫。在此背景下,ICT应被视为初始筛查步骤而非确定性诊断程序,阳性或其他临床相关发现应促使进行定量血清学检查,并在有指征时进行额外的实验室或分子检查。图1提出了该方法的一个可能框架。
[图:临床健康猫利什曼原虫(L. infantum)血清学筛查及随访流程图。*血清学]

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猫即时检测应如何验证?
未来的猫ICT应在特征明确的人群中进行前瞻性评估,包括确诊临床猫利什曼病的猫、感染但表观健康的猫、患有其他感染性、炎症性或肿瘤性疾病的动物以及未暴露的对照。应特别关注谱偏倚、交叉反应性、视觉判读的可重复性以及在低抗体浓度猫中的性能。使用血清、血浆和全血进行比较评估也将阐明在真实即时检测条件下的适用性(Puerta López等,2026)。
一个主要的方法学问题是利什曼病缺乏完美的诊断金标准。在犬利什曼病中,这一局限性可通过已有多种在犬中专门验证的血清学方法来部分缓解(Miró等,2008)。相应针对猫利什曼病验证的检测方法范围仍然相当有限。仅针对另一种不完美的血清学检测来估计新ICT的敏感性和特异性,可能导致不一致样本的错误分类和诊断准确性估计的偏倚。纳入分子、寄生虫学和血清学证据的复合参考标准,或者不假设存在完美参考检测的潜在类别方法,可能提供更稳健的诊断性能估计。多中心研究也将有助于评估跨实验室(Mahachi等,2024)、地理和临床人群(Solano-Gallego等,2014)、诊断目的和疾病表现(Villanueva-Saz等,2022)的可重复性。
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一个独特的诊断优先事项
更新的LeishVet建议指出,缺乏针对猫利什曼原虫感染的外部验证商业血清学检测是一个持续存在的诊断局限性(Pennisi等,2026)。同时,2026年发表的研究表明,这一局限性正开始通过以猫为中心的侧流技术评估和优化得到解决(González等,2026;Puerta López等,2026;Villanueva-Saz等,2026)。
多项研究表明,猫利什曼原虫(L. infantum)感染在流行病学上是可测量的,猫中的模式与犬中报道的不同,且诊断结果因所采用的方法而异(Pennisi等,2015;Persichetti等,2017;Alcover等,2021;Priolo等,2022)。免疫学发现为这些宿主特异性差异提供了额外的机制视角(Louzada-Flores等,2026),而侧流技术的进步证明了针对猫样本优化检测化学的可行性(Puerta López等,2026)。
综上所述,这些发现支持优先开发、优化并在猫中专门评估血清学工具并进行外部验证,而不是将缺乏猫适配的ICT视为主要诊断空白。进一步的工作应在明确界定的猫群体中表征分析性能和临床性能,评估检测性能如何随临床状态和抗体反应而变化,并确定即时血清学在哪些场景中提供有意义的附加价值。还需要前瞻性临床研究来确定猫适配ICT是否能提高利什曼原虫(L. infantum)感染的识别、支持合理选择确诊检测,或有助于更早识别具有临床相关性的病例。
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结论
FeL需要一种反映猫生物学和血清学特征的诊断方法,而不是依赖直接从犬模型外推。为此,物种适配的即时血清学可提高对疑似病例的早期识别,并支持更及时地选择确诊检测,前提是这些检测经过严格验证并在多模式诊断框架内解读。因此,其开发应被视为改善猫利什曼原虫(L. infantum)感染的临床诊断和流行病学理解的重要一步。
伦理批准
不适用。
作者贡献声明
Sergio Villanueva-Saz:概念构思、撰写—原稿、撰写—审阅与编辑、资源、监督。Diana Marteles-Aragüés:概念构思、撰写—原稿、撰写—审阅与编辑、资源、监督。
数据可用性
支持本研究结果的数据包含在本已发表文章中。
关于使用AI辅助技术的声明
本手稿中未使用生成式AI或AI辅助工具创建或修改图表、图像或美术作品。所有图形材料均由专业员工图形设计师使用常规设计软件制作。
资助
作者未获得本研究、 authorship 和/或本文发表的经济支持。
利益冲突声明
作者声明,他们没有已知的可能影响本文工作的竞争性经济利益或个人关系。
贡献者信息
Sergio Villanueva-Saz,邮箱:svs@unizar.es。
Diana Marteles-Aragüés,邮箱:dmartelesaragues@unizar.es。
参考文献
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关联数据
数据可用性声明
支持本研究结果的数据包含在本已发表文章中。
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Diagnostic gap
Feline leishmaniosis (FeL) is increasingly recognised as a clinically relevant disease in Leishmania infantum-endemic areas, particularly in the Mediterranean Basin (Pereira and Maia, 2021; Garcia-Torres et al., 2022; Carbonara et al., 2024). In addition, accumulating epidemiological and xenodiagnostic evidence indicates that infected cats can contribute to the transmission cycle by infecting competent phlebotomine sand-fly vectors (Maroli et al., 2007), although their population-level importance as reservoirs remains less clearly established than that of dogs. The 2015 LeishVet recommendations therefore emphasised that FeL should be considered in cats presenting with compatible dermatological, ocular, oral, lymph node or systemic abnormalities, particularly in endemic areas (Pennisi et al., 2015). More than a decade after publication of these recommendations, however, an important diagnostic gap persists: the limited availability of rapid point-of-care serological assays specifically developed and validated for cats. This limitation is explicitly acknowledged in the updated LeishVet recommendations, which note that no commercial serological tests for feline Leishmania infection have yet been externally validated and published in a peer-reviewed journal, and caution against assuming that rapid tests developed for dogs are diagnostically accurate in cats (Pennisi et al., 2026).
Recent epidemiological evidence indicates that feline exposure to L. infantum is not exceptional. A multicentre study including 2067 cats from six Mediterranean countries reported an overall seropositivity of 17.3%. Shelter or free-roaming conditions and feline immunodeficiency virus infection were identified as risk factors, while seropositivity was associated with weight loss, lymphadenomegaly, gingivostomatitis, oral lesions, hyperglobulinaemia and a reduced albumin-to-globulin ratio (Carbonara et al., 2024).
Current diagnostic approaches include quantitative serology, molecular assays, cytology, histopathology, and immunohistochemistry. No single method provides complete diagnostic certainty, and complementary investigations are recommended when serology is negative or weakly positive in clinically suspect cats (Pennisi et al., 2026). Many of these techniques are difficult to integrate into immediate first-opinion decision-making. Molecular methods, western blot (WB), immunohistochemistry and parasite culture require adapted laboratory facilities, trained personnel or specific instrumentation. Cytology and histopathology depend on appropriate lesion selection and may require invasive sampling, whereas indirect fluorescent antibody testing (IFAT) and enzyme-linked immunosorbent assays (ELISA) generally do not provide results during the consultation. These limitations may delay recognition of FeL when clinical abnormalities are mild or non-specific. This contrasts with canine leishmaniosis (CanL), in which rapid immunochromatographic tests (ICTs) are widely incorporated into routine diagnostic workflows (Villanueva-Saz et al., 2022). The relevant question is therefore not simply why rapid tests are widely used in dogs but less frequently in cats. Rather, it is whether the canine serological paradigm is appropriate for feline infection.
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Why cats require species-adapted serology
Cats and dogs exposed to L. infantum do not necessarily develop diagnostically equivalent antibody responses. In naturally exposed cats and dogs from the same endemic area, similar overall frequencies of parasite exposure or infection were observed when serological, molecular and cell-mediated immune markers were considered collectively. However, dogs exhibited significantly higher anti-L. infantum antibody levels than cats, indicating host-dependent differences in the immune response (Priolo et al., 2022).
In feline monocyte-derived macrophages infected in vitro with L. infantum, interleukin (IL)-2, interferon (IFN)-γ and tumour necrosis factor (TNF)-α were upregulated, whereas IL-4 and IL-6 remained relatively stable and IL-10 expression decreased. This predominantly T helper 1-like inflammatory profile may contribute to partial control of infection and has been proposed as one possible explanation for the generally milder clinical course observed in cats compared with dogs (Louzada-Flores et al., 2026).
Early evidence also supports a species-specific immunological response to Leishmania spp. infection in cats, including parasite-specific cell-mediated response and host-parasite interactions that may differ from those described in dogs and humans (Pereira and Maia, 2021). These observations suggest that the feline immune response to L. infantum should not be extrapolated from the canine model (Pereira and Maia, 2021; Louzada-Flores et al., 2026).
Different diagnostic measures have been described when serological techniques have been evaluated in FeL. In this sense, Bayesian analysis performed without assuming a perfect diagnostic gold standard estimated median sensitivities of 97% for WB, 75% for IFAT and 70% for ELISA, with corresponding specificities of 99%, 97% and 98%, respectively (Persichetti et al., 2017). In apparently healthy stray cats from Zaragoza, Spain, positivity ranged from 2.2% by IFAT and 2.8% by ELISA to 14.5% by WB, whereas L. infantum DNA was detected in blood by quantitative PCR in 5.6% of cats. Overall, 15.6% were considered infected based on serological and/or molecular evidence, but only two animals were positive by all methods (Alcover et al., 2021). Although these results cannot be directly extrapolated to cats with overt FeL, they illustrate how recognition of feline infection depends on the diagnostic platform selected.
Further evidence of this diagnostic heterogeneity comes from a study of 166 shelter cats, in which markedly different detection rates were obtained by ELISA (15%), IFAT (53.6%), molecular methods (3.6%) and parasitological examination (1.8%) (Silva et al., 2023). Although these estimates depend on the population studied and the diagnostic criteria and cut-offs applied, the marked differences between methods further demonstrate that individual assays are not interchangeable and support the use of complementary diagnostic approaches (Silva et al., 2023).
Anti-Leishmania antibody detection should therefore not be considered directly equivalent across host species. Within feline serology, antigen selection influences antibody recognition, as different L. infantum antigens generate heterogeneous and partly complementary serological profiles (Lima et al., 2026). Assay detection chemistry can likewise affect analytical performance in feline samples, as evidenced by the improved sensitivity and test-line intensity achieved with a latex-based lateral-flow format compared with a conventional colloidal-gold system (Puerta López et al., 2026). Immunoglobulin-binding reagents may also exhibit species-dependent affinities across mammalian taxa (Villanueva-Saz et al., 2026). Nevertheless, antigen selection, detection chemistry and detection thresholds should primarily be regarded as variables requiring feline-specific optimisation and validation rather than as established intrinsic differences between feline and canine serology. Serological specificity may be further affected by exposure to other Leishmania species. For example, IFAT cross-reactivity between L. infantum and Leishmania tarentolae in naturally exposed outdoor cats represents an additional diagnostic challenge and demonstrates the importance of antigen selection and assay-specific validation in feline serology (Mendoza-Roldan et al., 2025).
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What point-of-care serology could add
The primary value of a point-of-care assay lies not in replacing conventional laboratory diagnostics, but in providing rapid, clinically relevant information at the time of decision-making as an initial step in a diagnostic algorithm. Although this approach is routinely used in dogs (Maia and Campino, 2018), an externally validated, feline-adapted point-of-care serological strategy has not yet become established in clinical practice (Pennisi et al., 2026). An ICT with insufficient sensitivity for low-level feline antibody responses could reinforce the perception that FeL is rare by generating negative results in animals in which clinical suspicion is already low. By contrast, a feline-adapted assay could lower the threshold for further investigation and alter clinical reasoning at presentation.
A recent clinical case report supports this potential. In a cat with unilateral uveitis, a commercial rapid test for anti-L. infantum antibodies was positive in serum and aqueous humour. Infection was subsequently supported by ELISA, WB, PCR in blood and aqueous humour, and parasite isolation with molecular identification as L. infantum (González et al., 2026). The ICT did not independently establish the diagnosis; instead, immediate serological information was incorporated into a broader diagnostic investigation.
In an evaluation of a commercial ICT involving 186 serum samples from domestic and non-domestic species, complete agreement between the ICT and reference serological classification was observed among the feline samples included. Marked species-dependent differences occurred in other taxa, particularly herbivores, highlighting the importance of conjugate-immunoglobulin interactions and species-specific assay validation (Villanueva-Saz et al., 2026). More recently, development of a feline-specific latex-based ICT demonstrated that optimisation of detection chemistry can substantially improve serological detection in cats. Compared with a conventional colloidal-gold system, the latex-based assay showed markedly higher sensitivity while maintaining very high specificity and improving test-line signal intensity (Puerta López et al., 2026).
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The appropriate clinical role of a feline ICT
A feline-specific ICT should not be viewed as a stand-alone test capable of diagnosing clinical FeL. A positive antibody result does not independently establish that L. infantum is responsible for clinical abnormalities, because exposure or subclinical infection may coexist with unrelated disorders. Similarly, cats with compatible clinical signs and negative or weakly positive serology may still require molecular or parasitological investigation (Pennisi et al., 2026). The greatest value of a validated feline ICT may therefore be as a first-line triage tool within a multimodal diagnostic pathway, especially in cats from L. infantum-endemic areas presenting with compatible clinical signs and/or compatible laboratory abnormalities. An immediate positive result could strengthen clinical suspicion and justify further testing, including quantitative serology, molecular testing, cytology, or direct parasite detection such as immunohistochemistry or parasite isolation. Conversely, a negative result should not terminate the diagnostic investigation when clinical suspicion remains high, and the use of additional confirmatory techniques should be recommended. Diagnostic usefulness depends not only on sensitivity and specificity but also on the target population and the clinical decisions triggered by the result. Point-of-care testing may therefore provide value if it accelerates recognition of an underdiagnosed differential and directs appropriate confirmatory investigation.
Beyond its potential use in clinically suspected cases, point-of-care serology may also have a role in selected apparently healthy cats with epidemiological exposure to L. infantum, particularly those living in or travelling to endemic areas. In this setting, an ICT should be regarded as an initial screening step rather than a definitive diagnostic procedure, with positive or otherwise clinically relevant findings prompting quantitative serology and, when indicated, additional laboratory or molecular investigation. A possible framework for this approach is proposed in Fig. 1.
[图:Flowchart for the serological screening and follow-up of clinically healthy cats for Leishmania infantum . *Serological ]

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How should feline point-of-care tests be validated?
Future feline ICTs should be assessed prospectively in well-characterised populations that include cats with confirmed clinical FeL, infected but apparently healthy cats, animals with other infectious, inflammatory or neoplastic diseases, and unexposed controls. Particular attention should be given to spectrum bias, cross-reactivity, reproducibility of visual interpretation and performance in cats with low antibody concentrations. Comparative assessment using serum, plasma and whole blood would also clarify applicability under genuine point-of-care conditions (Puerta López et al., 2026).
A major methodological problem is the absence of a perfect diagnostic gold standard for leishmaniosis. In CanL, this limitation can be partially mitigated by the availability of several serological methods validated specifically in dogs (Miró et al., 2008). The corresponding range of assays validated for FeL remains considerably more limited. Estimating sensitivity and specificity of a new ICT solely against another imperfect serological test may consequently lead to misclassification of discordant samples and biased estimates of diagnostic accuracy. Composite reference standards incorporating molecular, parasitological and serological evidence, or alternatively latent-class approaches that do not assume the existence of a perfect reference test, may provide more robust estimates of diagnostic performance. Multicentre studies would also be desirable to assess reproducibility across laboratories (Mahachi et al., 2024), geographical and clinical populations (Solano-Gallego et al., 2014), diagnostic purposes and disease presentations (Villanueva-Saz et al., 2022).
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A distinct diagnostic priority
The updated LeishVet recommendations identify the lack of externally validated commercial serological assays for feline Leishmania infection as a persisting diagnostic limitation (Pennisi et al., 2026). Concurrently, studies published in 2026 suggest that this limitation is beginning to be addressed through feline-focused evaluation and optimisation of lateral-flow technologies (González et al., 2026; Puerta López et al., 2026; Villanueva-Saz et al., 2026).
Several studies indicate that feline L. infantum infection is epidemiologically measurable, with patterns in cats differing from those reported in dogs, and that diagnostic outcomes vary according to the method employed (Pennisi et al., 2015; Persichetti et al., 2017; Alcover et al., 2021; Priolo et al., 2022). Immunological findings provide an additional mechanistic perspective on these host-specific differences (Louzada-Flores et al., 2026), while advances in lateral-flow technology demonstrate the feasibility of optimising assay chemistry for feline samples (Puerta López et al., 2026).
Taken together, these findings support prioritising the development, optimisation and external validation of serological tools specifically evaluated in cats, rather than considering the absence of a feline-adapted ICT as the principal diagnostic gap. Further work should characterise analytical and clinical performance in well-defined feline populations, assess how test performance varies with clinical status and antibody response, and determine the settings in which point-of-care serology provides meaningful additional value. Prospective clinical investigations will also be required to establish whether feline-adapted ICTs improve recognition of L. infantum infection, support appropriate selection for confirmatory testing, or contribute to earlier identification of clinically relevant cases.
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Conclusions
FeL requires a diagnostic approach that reflects the biological and serological characteristics of cats rather than relying on direct extrapolation from canine models. For this purpose, species-adapted point-of-care serology could improve early recognition of suspected cases and support more timely selection of confirmatory tests, provided that these assays are rigorously validated and interpreted within a multimodal diagnostic framework. Their development should therefore be considered an important step towards improving both the clinical diagnosis and epidemiological understanding of L. infantum infection in cats.
Ethical approval
Not applicable.
Credit authorship contribution statement
Sergio Villanueva-Saz: Conceptualization, Writing - original draft, Writing-review & editing, Resources, Supervision. Diana Marteles-Aragüés: Conceptualization, Writing - original draft, Writing-review & editing, Resources, Supervision.
Data availability
The data supporting the findings of this study are included in this published article.
Statement on the use of AI-assisted technologies
No generative AI or AI-assisted tools were used in the creation or modification of figures, images, or artwork in this manuscript. All graphical materials were produced by professional staff graphic designers using conventional design software.
Funding
The authors received no financial support for the research, authorship, and/or publication of this article.
Declaration of competing interests
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Contributor Information
Sergio Villanueva-Saz, Email: svs@unizar.es.
Diana Marteles-Aragüés, Email: dmartelesaragues@unizar.es.
References
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Associated Data
Data Availability Statement
The data supporting the findings of this study are included in this published article.
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