Table 2

Results for all LFIAs analysed

Lateral flow assaySensitivitySpecificity
Sera (vs positives on S-ELISA and/or hybrid DABA)Finger-prick self-test (vs positives on S-ELISA and/or hybrid DABA)Police force sera Nov 2019 (all positives considered false)
Sensitivity95% CIn/NSensitivity95% CIn/NSpecificity95% CI n=Invalidity (n)
Phase IWONDFO (IgM/IgG combined)80%70.2 to 87.475/9422%13.1 to 33.116/7399.4%98.3 to 99.9497/5000% (0)
MENARINI (separate IgM and IgG)93%(86.3 to 96.5112/12196%84.9 to 99.543/4597.8%96.1 to 98.9489/5000.6% (3)
FORTRESS (separate IgM and IgG)88%83.3 to 91.2255/29184%70.5 to 93.538/4598.6%97.1 to 99.4493/5000.6% (3)
BIOPANDA I (separate IgM and IgG)65%56.7 to 72.2101/15667%55.5 to 76.656/8499.8%98.9 to 100.0499/5000% (0)
BIOSURE/MOLOGIC I (IgG only)71%62.2 to 77.998/13961%46.2 to 74.830/4997.2%95.3 to 98.5486/5001.6% (8)
Phase IISURE-BIOTECH (separate IgM and IgG)68%57.3 to 77.163/93
BIOSURE/MOLOGIC II (IgG only)*48%40.8 to 55.987/180
BIOPANDA II (separate IgM and IgG)82%75.7 to 86.4151/18498.4%96.5 to 99.2442/4500% (0)
BIOMERICA (separate IgM and IgG)81%74.7 to 86.4149/18497.8%96.1 to 98.9489/5000% (0)
SURESCREEN (separate IgM and IgG)88%81.8 to 91.9161/18499.8%98.9 to 100499/5000% (0)
ABBOTT (separate IgM and IgG)91%85.6 to 94.5167/18499.8%98.9 to 100499/5000% (0)
Reference assays Laboratory test vs PCR-confirmed cases
S-ELISA94.5%91.4 to 96.8293/310
RBD hybrid DABA94.8%91.6 to 97.1274/289
Composite ELISA/hybrid DABA positivity95.2%92.2 to 97.3296/311
  • Biosure/Mologic II was tested with 5 µL serum in phase II (in accordance with instructions provided at time). Manufacturer advises test should be performed with 10 µL serum.

  • DABA, Double antigen bridging assay; IgG, immunoglobulin G; IgM, immunoglobulin M; RBD, Receptor binding domain; S-ELISA, spike protein ELISA.