Evaluation of the Advanta Dx SARS-CoV-2 RT-PCR Assay, a High-Throughput Extraction-Free Diagnostic Test for the Detection of SARS-CoV-2 in Saliva: A Diagnostic Accuracy Study

Abstract

Nasopharyngeal swab specimen (NPS) molecular testing is considered the gold standard for SARS-CoV-2 detection. However, saliva is an attractive, noninvasive specimen alternative. The aim of the study was to evaluate the diagnostic accuracy of Advanta Dx SARS-CoV-2 RT-PCR saliva-based assay against paired NPS tested with either NeumoDxTM SARS-CoV-2 assay or Abbott Real Time SARS-CoV-2 assay as the reference method. We prospectively evaluated the method in two settings: a diagnostic outpatient and a healthcare worker screening convenience sample, collected in November–December 2020. SARS-CoV-2 was detected in 27.7% (61/220) of diagnostic samples and in 5% (10/200) of screening samples. Overall, saliva test in diagnostic samples had a sensitivity of 88.5% (77.8–95.3%) and specificity of 98.1% (94.6–99.6%); in screening samples, the sensitivity was 90% (55.5–99.7%) and specificity 100% (98.1–100%). Our data suggests that the Fluidigm Advanta Dx RT-PCR saliva-based assay may be a reliable diagnostic tool for COVID-19 diagnosis in symptomatic individuals and screening asymptomatic healthcare workers.

Salivary SARS-CoV-2 RNA for diagnosis of COVID-19 patients: A systematic review and meta-analysis of diagnostic accuracy

“…All studies were published in 2020–2022 and were conducted in Argentina [31] , Belgium [32] , Bangladesh [33] , Brazil [14] , [34] , [35] , [36] , [37] , Canada [38] , [39] , [40] , [41] , [42] , Ethiopia [43] , France [44] , [45] , Greece [46] , India [47] , Iran [48] , Italy [49] , Japan [50] , [51] , [52] , [53] , Mexico [54] , [55] , Pakistan [56] , Philippines [57] , South Korea [58] , Thailand [59] , Turkey [60] , [61] , United Arab Emirates [62] , United Kingdom [63] , United States of America [64] , [65] , [66] , [67] , [68] , [69] , [70] , [71] , [72] , [73] . The total number of participants was 14,043, and the age varied between 18 and 106 years old.…”

“…The total number of participants was 14,043, and the age varied between 18 and 106 years old. Twenty-two studies only included patients who had symptoms of COVID-19 [14] , [31] , [33] , [34] , [37] , [43] , [47] , [48] , [50] , [51] , [53] , [54] , [55] , [57] , [59] , [60] , [61] , [65] , [68] , [70] , [71] , [73] , seventeen studies included symptomatic and asymptomatic patients [32] , [35] , [36] , [38] , [39] , [41] , [42] , [44] , [45] , [46] , [49] , [58] , [62] , [63] , [64] , [66] , [69] , one study included only asymptomatic patients [52] , and four studies did not report these data [40] , [56] , [67] , [72] . Other sources of information regarding demographics, characteristics of the population, and characteristics of the samples are available in Table 2 .…”

“… Author Country Population Symptoms Diagnosis RNA extraction kit PCR-Kit Target gene for RT-PCR test Swab type Swab type Saliva collection N Age Abdollahiet et al Iran 80 (emergency unit’s triage) 56.5 ± 16.8 [24] , [25] , [26] , [27] , [28] , [29] , [30] , [31] , [32] , [33] , [34] , [35] , [36] , [37] , [38] , [39] , [40] , [41] , [42] , [43] , [44] , [45] , [46] , [47] , [48] , [49] , [50] , [51] , [52] , [53] , [54] , [55] , [56] , [57] , [58] , [59] , [60] , [61] , [62] , [63] , [64] , [65] , [66] , [67] , …”

“… NR Oro-Nasopharyngeal Whole saliva (drooling method) Guimarãeset et al Brazil 189 39.6 ± 12.3 Symptomatic patients Viral RNA detection with PCR from NPS Bio-Gene DNA/RNA Viral Extraction, by Bioclin SARS-CoV-2 molecular kit, by Bio-Manguinhos SARS-CoV-2 envelope gene Nasopharyngeal Whole saliva (spit) Hansonet et al United States of America 353 (drive-through test center) 35 [18] , [19] , [20] , [21] , [22] , [23] , [24] , [25] , [26] , [27] , [28] , [29] , [30] , [31] , [32] , [33] , [34] , [35] , [36] , [37] , [38] , [39] , [40] , [41] , [42] , [43] , [44] , [45] , [46] , [47] , [48] , [49] , [50] , [51] , [52] , [53] , [54] , [55] , [56] , [57] , [58] , [59] , [60] , …”

The Coronavirus Disease 2019 Spatial Care Path: Home, Community, and Emergency Diagnostic Portals

“…Table 1 summarizes performance metrics for the primary study groups (left column) and lists supporting tabulations (right column) found in the Supplementary Materials. Papers generated by PubMed, other searches, and bibliographies of systematic reviews and meta-analyses comprised (a) 34 clinical evaluations of the use of RAgTs in communities (see Table S2); (b) 30 clinical evaluations of RAgTs applied in emergency medicine (emergency rooms and emergency departments), including 9 with results for pediatric patients [58,[65][66][67][68][69][70][71][72] (Table S3); and (c) 18 clinical evaluations [73][74][75][76][77][78][79][80][81][82][83][84][85][86][87][88][89][90] that reported results for PCR-based testing of saliva in community groups of strictly asymptomatic subjects (Table S4). No human subjects were involved in this research.…”