Clinical evaluation of AusDiagnostics SARS-CoV-2 multiplex tandem PCR assay

Attwood, Lucy O; Francis, Michelle J; Hamblin, John; Korman, Tony M.; Druce, Julian; Graham, Maryza

doi:10.1016/j.jcv.2020.104448

Cited by 32 publications

(35 citation statements)

References 16 publications

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“…Comparative analysis with State Reference Laboratory showed 118/127 (92.9%) consistency. After investigation of discrepancies, 125/127 (98.4%) positive results were obtained and this method has demonstrated reliable diagnosis for SARS-CoV-2 [ 67 ]. Protocols established in various countries for RT-PCR available on the WHO website.…”

Section: Current Detection Methods For Sars-cov-2mentioning

confidence: 99%

“… 173 [ 25 ] RT-PCR CRISPR Metagenomic next-generation sequencing (mNGS) N gene NP Three methods consist of an identical RNA extraction procedure, which takes about an hour. Turn-around time of RT–PCR, CRISPR & mNGS is about 3, 2 and 24 h, no obvious difference in safety among these approaches [ 107 ] MT-PCR ORF1 gene NP/OP Tandem PCR, High specificity (98.4%) 7839 [ 67 ] dPCR ORFAlab & N NP, Stool, Blood LOD dPCR is at least 10-fold lower than that of RT-PCRAccuracy 96.3%. 108 [ 108 ] RT-dPCR ORF 1 ab, N & E genes 2copies/reaction NP For fever suspected patients, the sensitivity was greatly enhanced from 28.2% by RT-qPCR to 87.4% by RT-dPCR.…”

Section: Novel Developed Technologies For Sars-cov-2 Detectionmentioning

confidence: 99%

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Diagnostic techniques for COVID-19 and new developments

Sheikhzadeh

Eissa

Ismail

et al. 2020

Talanta

129

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COVID-19 pandemic is a serious global health issue today due to the rapid human to human transmission of SARS-CoV-2, a new type of coronavirus that causes fatal pneumonia. SARS -CoV-2 has a faster rate of transmission than other coronaviruses such as SARS and MERS and until now there are no approved specific drugs or vaccines for treatment. Thus, early diagnosis is crucial to prevent the extensive spread of the disease. The reverse transcription-polymerase chain reaction (RT-PCR) is the most routinely used method until now to detect SARS-CoV-2 infections. However, several other faster and accurate assays are being developed for the diagnosis of COVID-19 aiming to control the spread of infection through the identification of patients and immediate isolation. In this review, we will discuss the various detection methods of the SARS-CoV-2 virus including the recent developments in immunological assays, amplification techniques as well as biosensors.

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Section: Current Detection Methods For Sars-cov-2mentioning

confidence: 99%

Section: Novel Developed Technologies For Sars-cov-2 Detectionmentioning

confidence: 99%

Diagnostic techniques for COVID-19 and new developments

Sheikhzadeh

Eissa

Ismail

et al. 2020

Talanta

129

View full text Add to dashboard Cite

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“…Combined oropharyngeal and nasopharyngeal swabs were collected as recommended [ 8 ] and according to national guidelines [ 9 ] using FLOQSwabs® and transported in UTM medium (Copan, Brescia, Italy) by a trained health professional (nurse or midwife) wearing appropriate PPE consisting of a gown, nonsterile gloves, eye protection and a protective mask. SARS-CoV-2 testing was then performed utilising multiplex-tandem polymerase chain reaction (PCR, AusDiagnostics, Mascot, Australia), an assay with demonstrated high sensitivity and specificity (>99.9%) [ 10 ]. Turnaround times for test results are usually between 24 to 48 h. In case of positive results, the Department of Health is notified for further management and contact tracing, and patients immediately contacted and told to stay at home unless concerning symptoms are present, in which case they should seek health care through their local hospital.…”

Section: Methodsmentioning

confidence: 99%

Coronavirus testing in women attending antenatal care

et al. 2021

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Background Universal screening has been proposed as a strategy to identify asymptomatic individuals infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and mitigate transmission. Aim To investigate the rate of positive tests among pregnant women in Melbourne, Australia. Methods We performed a cross-sectional prevalence study at three maternity hospitals (one tertiary referral hospital and two secondary maternities) in Melbourne, Australia. SARS-CoV-2 testing was offered to all pregnant women attending face-to-face antenatal visits and to those attending the hospital with symptoms of possible coronavirus disease, between 6th and 19th of May 2020. Testing was performed by multiplex-tandem polymerase chain reaction (PCR) on combined oropharyngeal and nasopharyngeal swabs. The primary outcome was the proportion of positive SARS-CoV-2 tests. Findings SARS-CoV-2 testing was performed in 350 women, of whom 19 had symptoms of possible COVID-19. The median maternal age was 32 years (IQR 28–35 years), and the median gestational age at testing was 33 weeks and four days (IQR 28 weeks to 36 weeks and two days). All 350 tests returned negative results (p̂ = 0%, 95% CI 0–0.86%). Conclusion In a two-week period of low disease prevalence, the rate of asymptomatic coronavirus infection among pregnant women in Australia during the study period was negligible, reflecting low levels of community transmission.

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“…Combined oropharyngeal and nasopharyngeal swabs were collected as recommended 7 and according to national guidelines 8 using FLOQSwabs ® and transported in UTM medium (Copan, Brescia, Italy) by a trained health professional (nurse or midwife) wearing appropriate PPE consisting of a gown, nonsterile gloves, eye protection and a protective mask. SARS-CoV-2 testing was then performed utilising multiplex-tandem polymerase chain reaction (PCR, AusDiagnostics, Mascot, Australia), an assay with demonstrated high sensitivity and specificity (>99.9%) 9 .…”

Section: Methodsmentioning

confidence: 99%

Novel coronavirus 2019 testing in women attending routine antenatal care: a cross-sectional study

Rolnik

Korman

Rindt

et al. 2020

Preprint

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Objective: Universal screening has been proposed as a strategy to identify asymptomatic individuals infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and mitigate transmission. We aimed to investigate the rate of positive tests among pregnant women attending routine antenatal care. Design: Cross-sectional prevalence study. Setting: Antenatal clinic at three maternity hospitals (one tertiary referral hospital and two secondary maternities) in Melbourne, Australia. Population: Asymptomatic pregnant women attending routine antenatal care and pregnant women undergoing testing with symptoms of possible coronavirus disease. Methods: SARS-CoV-2 testing was offered to all pregnant women attending faceto-face antenatal visits and to those attending the hospital with symptoms of possible coronavirus disease, between 6th and 19th of May 2020. Testing was performed by multiplex-tandem polymerase chain reaction (PCR) on combined oropharyngeal and nasopharyngeal swabs. Main Outcome Measures: Proportion of positive SARS-CoV-2 tests. Results: SARS-CoV-2 testing was performed in 350 women, of whom 19 had symptoms of possible COVID-19. The median maternal age was 32 years (IQR 28 to 35 years), and the median gestational age at testing was 33 weeks and four days (IQR 28 weeks to 36 weeks and two days). All 350 tests returned negative results (p = 0%, 95% CI 0 to 0.86%). Conclusion: The rate of asymptomatic coronavirus infection among pregnant women in Australia during the study period was negligible, which reflected reassuringly low levels of community transmission.

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Clinical evaluation of AusDiagnostics SARS-CoV-2 multiplex tandem PCR assay

Cited by 32 publications

References 16 publications

Diagnostic techniques for COVID-19 and new developments

Diagnostic techniques for COVID-19 and new developments

Coronavirus testing in women attending antenatal care

Novel coronavirus 2019 testing in women attending routine antenatal care: a cross-sectional study

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