A high throughput immuno-affinity mass spectrometry method for detection and quantitation of SARS-CoV-2 nucleoprotein in human saliva and its comparison with RT-PCR, RT-LAMP, and lateral flow rapid antigen test

Clin Chem Lab Med. 2024 Jan 23;62(6):1206-1216. doi: 10.1515/cclm-2023-0243. Print 2024 May 27.

Abstract

Objectives: Many reverse transcription polymerase chain reaction (RT-PCR) methods exist that can detect SARS-CoV-2 RNA in different matrices. RT-PCR is highly sensitive, although viral RNA may be detected long after active infection has taken place. SARS-CoV-2 proteins have shorter detection windows hence their detection might be more meaningful. Given salivary droplets represent a main source of transmission, we explored the detection of viral RNA and protein using four different detection platforms including SISCAPA peptide immunoaffinity liquid chromatography-mass spectrometry (SISCAPA-LC-MS) using polyclonal capture antibodies.

Methods: The SISCAPA-LC MS method was compared to RT-PCR, RT-loop-mediated isothermal amplification (RT-LAMP), and a lateral flow rapid antigen test (RAT) for the detection of virus material in the drool saliva of 102 patients hospitalised after infection with SARS-CoV-2. Cycle thresholds (Ct) of RT-PCR (E gene) were compared to RT-LAMP time-to-positive (TTP) (NE and Orf1a genes), RAT optical densitometry measurements (test line/control line ratio) and to SISCAPA-LC-MS for measurements of viral protein.

Results: SISCAPA-LC-MS showed low sensitivity (37.7 %) but high specificity (89.8 %). RAT showed lower sensitivity (24.5 %) and high specificity (100 %). RT-LAMP had high sensitivity (83.0 %) and specificity (100.0 %). At high initial viral RNA loads (<20 Ct), results obtained using SISCAPA-LC-MS correlated with RT-PCR (R2 0.57, p-value 0.002).

Conclusions: Detection of SARS-CoV-2 nucleoprotein in saliva was less frequent than the detection of viral RNA. The SISCAPA-LC-MS method allowed processing of multiple samples in <150 min and was scalable, enabling high throughput.

Keywords: RT-LAMP; RT-PCR; SARS-CoV-2; immuno-affinity; mass spectrometry; rapid antigen test.

Publication types

  • Comparative Study

MeSH terms

  • Adult
  • Antigens, Viral / analysis
  • Antigens, Viral / immunology
  • COVID-19* / diagnosis
  • COVID-19* / virology
  • Chromatography, Liquid / methods
  • Coronavirus Nucleocapsid Proteins / analysis
  • Coronavirus Nucleocapsid Proteins / immunology
  • Female
  • Humans
  • Male
  • Mass Spectrometry* / methods
  • Middle Aged
  • Molecular Diagnostic Techniques*
  • Nucleic Acid Amplification Techniques / methods
  • Phosphoproteins / analysis
  • Phosphoproteins / immunology
  • RNA, Viral* / analysis
  • Reverse Transcriptase Polymerase Chain Reaction / methods
  • SARS-CoV-2* / genetics
  • SARS-CoV-2* / immunology
  • SARS-CoV-2* / isolation & purification
  • Saliva* / chemistry
  • Saliva* / virology
  • Sensitivity and Specificity

Substances

  • RNA, Viral
  • nucleocapsid phosphoprotein, SARS-CoV-2
  • Phosphoproteins
  • Coronavirus Nucleocapsid Proteins
  • Antigens, Viral

Supplementary concepts

  • LAMP assay