Diagnostic performance and characteristics of anterior nasal collection for the SARS-CoV-2 antigen test: a prospective study

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The clinical utility of antigen test using anterior nasal samples has not been well evaluated. We conducted a prospective study in a drive-through testing site located at a PCR center to evaluate the diagnostic performance of the antigen test QuickNavi-COVID19 Ag using anterior nasal samples and to compare the degrees of coughs or sneezes induction and the severity of pain between anterior nasal collection and nasopharyngeal collection. The study included a total of 862 participants, of which 91.6% were symptomatic.

The median duration from symptom onset to sample collection was 2.0 days. Fifty-one participants tested positive for severe acute respiratory syndrome coronavirus 2 on reverse transcription PCR (RT-PCR) with nasopharyngeal samples, and all of them were symptomatic. In comparison to the findings of RT-PCR, the antigen test using anterior nasal samples showed 72.5% sensitivity (95% confidence interval [CI] 58.3-84.1%) and 100% specificity (95% CI 99.3-100%). Anterior nasal collection was associated with a significantly lower degree of coughs or sneezes induction and the severity of pain in comparison to nasopharyngeal collection (p < 0.001). The antigen test using Rapid Antigen Test Nasal SD Biosensor anterior nasal samples showed moderate sensitivity in symptomatic patients who were at the early stages of the disease course but was less painful and induced fewer coughs or sneezes.

The multiple-antigen simultaneous test (MAST) is a simple system that uses no radioactive agents and allows simultaneous examination of multiple antigens.

  • CAP is a quick new, in vitro system that is more sensitive than the radio-allergosorbent test (RAST). To evaluate their clinical efficacies, we examined the correlation between the MAST and CAP systems. Serum samples were collected from 33 patients with nasal allergies, 13 males and 20 females, mean age 31.1 years.
  • The MAST and CAP were used for 7 inhaled allergens: house dust, Dermatophagoides farinae, Japanese cedar, timothy, sweet vernal grass, ragweed and mugwort. The correlation coefficients found for MAST and CAP were significant for all the allergens tested.
  • In addition, high values for sensitivity, specificity and efficiency were obtained for all the allergens. The MAST system provided the same information as the CAP system. Although CAP tended to have better sensitivity, some of its positive results may clinically be false-positive.
  • We believe that the MAST and CAP are both useful for the detection of allergens but that the diagnosis of allergy must be based on results of detailed examinations such as use of the skin test, the nasal provocation test and clinical symptoms.
  • The potential for ocular allergic patients to have a site-specific antigen sensitisation was investigated using various diagnostic tests of allergen sensitivity in subjects with allergic conjunctivitis (AC: n = 135), vernal keratoconjunctivitis (VK: n = 20), rhinoconjunctivitis (n = 20) or rhinitis (N = 10).
  • In the AC and VK patients, skin tests and conjunctival provocation tests (CPT) were performed, and the levels of specific IgE in serum and in tears were identified. A subgroup of 36 patients was also challenged with a nasal-specific provocation test (NPT).
  • Results showed a poor correlation between skin test results and tear-specific IgE, and also between serum-specific IgE and tear-specific IgE in both AC and VK patients (K < 0.3). CPT and tear IgE were significantly correlated (K = 0.5) in the ocular allergic population. In patients with rhinoconjunctivitis or rhinitis, and in 10 normal subjects, results of CPT and NPT were in 100% agreement.
  • Conversely, in patients with only conjunctivitis, little correlation was found between the results of CPT and NPT (K = 0.3). Tear-specific IgE was the only positive diagnostic sign of antigen sensitivity in 35% of VK patients and 30% of AC patients. These results suggest that the conjunctiva can be a uniquely sensitised target organ in allergic patients.

Fluocortin butylester (FCB), a locally active corticosteroid, was inhaled as a fine powder mixed with lactose using the rhinolator in a comparative double-blind, crossover study against placebo.

Fifty patients of both sexes and aged from 16 to 46 years with an established seasonal allergic rhinitis, but free of symptoms, took part in this trial. The determination of the protective action after allergen provocation was performed after seven days treatment with 4 mg FCB or placebo. Measurements of the nasal resistance and the temperature were taken after provocation. The symptoms of nose and eyes were recorded. The protective effect of FCB against nasal provocation with grass pollen extracts was statistically proved.

Most SARS-CoV-2 antigen-detecting rapid diagnostic tests require nasopharyngeal sampling, which is frequently perceived as uncomfortable and requires healthcare professionals, thus limiting scale-up. Nasal sampling could enable self-sampling and increase acceptability. The term nasal sampling is often not used uniformly and sampling protocols differ.

This manufacturer-independent, prospective diagnostic accuracy study,

compared professional anterior nasal and nasal mid-turbinate sampling for a WHO-listed SARS-CoV-2 antigen-detecting rapid diagnostic test. The second group of participants collected a nasal mid-turbinate sample themselves and underwent a professional nasopharyngeal swab for comparison. The reference standard was real-time polymerase chain reaction (RT-PCR) using combined oro-/nasopharyngeal sampling.
Individuals with high suspicion of SARS-CoV-2 infection were tested. Sensitivity, specificity, and percent agreement were calculated. Self-sampling was observed without intervention. Feasibility was evaluated by observer and participant questionnaires.
 Among 132 symptomatic adults, both professional anterior nasal and nasal mid-turbinate sampling yielded a sensitivity of 86.1% (31/36 RT-PCR positives detected; 95%CI: 71.3-93.9) and a specificity of 100.0% (95%CI: 95.7-100). The positive percent agreement was 100% (95%CI: 89.0-100). Among 96 additional adults, self nasal mid-turbinate and professional nasopharyngeal sampling yielded an identical sensitivity of 91.2% (31/34; 95%CI 77.0-97.0). Specificity was 98.4% (95%CI: 91.4-99.9) with nasal mid-turbinate and 100.0% (95%CI: 94.2-100) with nasopharyngeal sampling. The positive percent agreement was 96.8% (95%CI: 83.8-99.8). Most participants (85.3%) considered self-sampling as easy to perform.

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 Professional anterior nasal and nasal mid-turbinate sampling are of equivalent accuracy for an antigen-detecting rapid diagnostic test in ambulatory symptomatic adults. Participants were able to reliably perform nasal mid-turbinate sampling themselves, following written and illustrated instructions. Nasal self-sampling will facilitate scaling of SARS-CoV-2 antigen testing.

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