Does Nozin application affect results of nasal swab PCR tests for viruses and non-MRSA bacteria?

Comment by InpharmD Researcher

There is a lack of data specifically evaluating whether Nozin affects the results of nasal swab PCR testing for viruses or detection of non-MRSA bacteria. One randomized study (Table 1) found that Nozin significantly reduced Staphylococcus aureus and total nasal bacterial carriage following three applications over a 10-hour period; however, the study evaluated bacterial colonization rather than the performance of bacterial cultures or molecular diagnostic tests. Indirect evidence from a small pilot study demonstrated that a different nasal antiseptic (octenidine; Table 2) did not increase false-negative SARS-CoV-2 RT-PCR or antigen test results, although these findings cannot be directly extrapolated to Nozin because of differences in formulation and active ingredients. Overall, there is insufficient evidence to determine whether Nozin influences viral PCR results or the detection of non-MRSA bacteria by nasal swab.
Background

A 2020 review article comprehensively describes the use of nasal disinfection for the prevention and control of Coronavirus disease 2019 (COVID-19) by highlighting the virucidal potential of alcohol-based nasal antiseptics against lipophilic enveloped viruses such as SARS-CoV-2, SARS-CoV-1, and MERS-CoV. Because these viruses are relatively easy to inactivate with alcohol, ethanol reagents between 62% and 71% can successfully disinfect surfaces within one minute, while concentrations above 30% can efficiently inactivate SARS-CoV-2 in suspension in just 30 seconds. Additionally, commercial 70% ethanol sanitizers have successfully abated the virus below detectable thresholds in suspension. Given this efficacy, the CDC recommends sanitizers with at least 60% ethanol for healthcare staff hand hygiene, and topical measures like saline nasal irrigations or ethanol oral rinses have been suggested as potential control options. The review also analyzed two clinical studies testing the over-the-counter product Nozin Nasal Sanitizer, which contains ethanol, natural oils, and benzalkonium chloride, against nasal bacterial carriage. These studies yielded conflicting data. Applying Nozin three times over eight hours significantly reduced S. aureus carriage in healthcare staff. However, the same regimen achieved only a transient reduction in colonized patients that became non-significant at the eight-hour mark. Alternative proposals have introduced the concept of inhaling controlled ethanol vapors from common alcoholic beverages to disinfect the airways. Ultimately, the authors recommend further clinical research to investigate the direct efficacy and localized tolerability of alcohol-based nasal antiseptics against SARS-CoV-2, particularly among vulnerable populations like pregnant women and children. Of note, while the potential virucidal impact is described, whether these alcohol-based nasal antiseptics, including Nozin, interfere with PCR test results was not detailed or assessed within this review. [1]

Background References: [1] Cegolon L, Javanbakht M, Mastrangelo G. Nasal disinfection for the prevention and control of COVID-19: A scoping review on potential chemo-preventive agents. Int J Hyg Environ Health. 2020;230:113605. doi:10.1016/j.ijheh.2020.113605
Literature Review

A search of the published medical literature revealed 2 studies investigating the researchable question:

Does Nozin application affect results of nasal swab PCR tests for viruses and non-MRSA bacteria?

Level of evidence

X - No data  Read more→


Please see Tables 1-2 for your response.

 

Reduction of nasal Staphylococcus aureus carriage in health care professionals by treatment with a nonantibiotic, alcohol-based nasal antiseptic
Design Randomized double-blind, placebo-controlled study N= 39
Objective To determine the effectiveness of a nonantibiotic, alcohol-based nasal antiseptic in reducing nasal bacterial carriage in health care professionals
Study Groups

Antiseptic treatment (n= 20)

Placebo treatment (n= 19)
Inclusion Criteria Healthy HCPs aged 18-70 years, able to refrain from using nasal sprays or washes, and screened positive for vestibular S aureus colonization
Exclusion Criteria Symptoms of upper respiratory disease, use of antibiotics in the 2 weeks prior, known allergy to citrus oil, or being a cigarette smoker
Methods

HCPs testing positive for S aureus colonization were treated with a nonantibiotic, alcohol-based antiseptic or placebo 3 times during a 10-hour workday. Nasal swab samples were collected before and after treatment to assess bacterial carriage.

A commercially available, nonprescription product, Nozin Nasal Sanitizer antiseptic (Global Life Technologies Corp, Chevy Chase, Md) was used as the test agent in this study.
Duration Single 10-hour workday
Outcome Measures Reduction in S aureus colony forming units 
Baseline Characteristics   Placebo Antiseptic
Total subjects 19 20
Mean age 35.4 (26-67) 34.5 (26-64)
Baseline colonization - S aureus 562 ± 1,113 756 ± 1,512
Baseline colonization - All strains 1,289 ± 1718 1,200 ± 1,694
Female 14 20
Male 5 0
Occupation - RN 10 15
Occupation - PCT/ORA 1 2
Occupation - MD/PA/NP/CRNA 5 0
Occupation - Other 3 3
Location - Floors 14 14
Location - Operating room 1 4
Location - Other 4 2
Results   Placebo Antiseptic p-value
S aureus CFU reduction (mean) - 82% <0.001
S aureus CFU reduction (median) - 99% <0.001
Total bacterial CFU reduction (mean) - 71% <0.001
Total bacterial CFU reduction (median) - 91% <0.001
Adverse Events No reports of dryness, irritation, or other discomfort associated with the antiseptic use
Study Author Conclusions Nasal application of a nonantibiotic, alcohol-based antiseptic effectively reduces S aureus and total bacterial carriage, providing a safe and convenient alternative to antibiotic treatment.
Critique The study effectively demonstrated the antiseptic's efficacy in reducing bacterial carriage. However, the short-term nature of the study does not address long-term effects or potential cumulative benefits. The small sample size and single-day duration limit the generalizability of the findings. Further studies are needed to assess long-term safety and effectiveness.
Table 1 References:
[2] Steed LL, Costello J, Lohia S, Jones T, Spannhake EW, Nguyen S. Reduction of nasal Staphylococcus aureus carriage in health care professionals by treatment with a nonantibiotic, alcohol-based nasal antiseptic. Am J Infect Control. 2014;42(8):841-846. doi:10.1016/j.ajic.2014.04.008

 

Application of Octenidine into Nasal Vestibules Does Not Influence SARS-CoV-2 Detection via PCR or Antigen Test Methods
Design Prospective-type accuracy pilot study N= 20
Objective To assess whether the application of an octenidine-containing nasal gel influences SARS-CoV-2 detection via antigen and RT-PCR test methods
Study Groups All patients (n= 20)
Inclusion Criteria Previously confirmed SARS-CoV-2-positive inpatients (RT-PCR Ct values < 40) older than 18 years with no or mild COVID-19 symptoms
Exclusion Criteria Body temperature ≥38°C, reported respiratory distress, shortness of breath, cough, flu-like symptoms, loss of taste, vomiting, diarrhea, or headache
Methods Patients applied a pea-sized amount of octenidine-based nasal gel into both nasal vestibules twice daily for 3 consecutive days. Nasal swabs for Ag analysis and nasopharyngeal swabs for RT-PCR analysis were collected before and after the intervention
Duration 3 days
Outcome Measures Influence of octenidine on SARS-CoV-2 detection via RT-PCR and antigen tests
Baseline Characteristics   All patients (n= 20)
Female 3 (15%)
Mean age, years 66.5 ± 13.5
Results

In this prospective study of 20 patients with confirmed SARS-CoV-2 infection (mean age 66.5 ± 13.5 years; 15% female), 3 days of intranasal octenidine application did not affect RT-PCR detection, as all participants remained PCR positive after treatment despite an increase in mean cycle threshold (Ct) values from 20.98 ± 5.14 at baseline to 26.36 ± 6.41 on day 3. Antigen test sensitivity was 75% before treatment and 80% after treatment, with false-negative results observed in 25% and 20% of patients, respectively. Overall, octenidine use did not increase false-negative RT-PCR or antigen test results, although antigen testing demonstrated lower sensitivity than RT-PCR regardless of antiseptic use.
Adverse Events No adverse events related to the application of octenidine were reported
Study Author Conclusions The application of an octenidine-based nasal gel does not influence SARS-CoV-2 screening results and is suitable for use in pre-surgical decontamination, even during SARS-CoV-2 epidemics.
Critique The study's small sample size limits the generalizability of the findings. Additionally, the use of different swab types for RT-PCR and antigen tests may introduce variability in results. However, the study provides valuable insights into the non-interference of octenidine with SARS-CoV-2 detection methods. Importantly, the findings of this study cannot be directly extrapolated to Nozin due to differences in formulation and active ingredients.
Table 2 References:
[3] Assadian O, Sigmund F, Herzog D, Riedl K, Klaus C. Application of Octenidine into Nasal Vestibules Does Not Influence SARS-CoV-2 Detection via PCR or Antigen Test Methods. Antibiotics (Basel). 2023;12(12):1724. Published 2023 Dec 13. doi:10.3390/antibiotics12121724