Table 1 Validation of linearity, sensitivity, and reproducibility of the ELISA with egg derived HAs.

From: Hemagglutinin Quantitative ELISA-based Potency Assay for Trivalent Seasonal Influenza Vaccine Using Group-Specific Universal Monoclonal Antibodies

Egg-derived HA (NIBSC)

uAb (group 2 IAV)

uAb (IBV)

4F11

10F8

Type

HA subtype

Strain

Response

Linearity (R2)

Sensitivity (LOD (µg/ml))

Reproducibility (%CV)

Response

Linearity (R2)

Sensitivity (LOD (µg/ml))

Reproducibility (%CV)

Group 1 IAV

H1

A/California/7/09 (NYMC-X181)

—

   

—

   

A/Brisbane/59/2007 (IVR-148)

—

   

—

   

H2

A/Singapore/1/57

—

   

—

   

H5

A/Anhui/1/05 IBCDC-RG-6

—

   

—

   

Group 2 IAV

H3

A/Hong Kong/4801/2014 (NYMC X-263B)

+

0.995

0.011

4.913

—

   

A/Switzerland/9715293/2013 (NIB88)

+

0.996

0.004

4.191

—

   

A/Texas/50/2012 (NYMC X-223A)

+

0.996

0.010

5.800

—

   

H7

A/mallard/Netherlands/12/2000

+

0.999

0.011

4.856

N/A

   

A/Anhui/1/2013

+

0.999

0.017

5.610

N/A

   

IBV

Yamagata

B/Phuket/3073/2013

-

   

+

1.000

0.004

3.799

B/Massachusetts/02/2012

—

   

+

0.993

0.006

6.250

Victoria

B/Brisbane/60/2008 (NYMC BX-35)

—

   

+

0.980

0.000*

5.287

B/Maryland/15/2016

N/A

   

+

0.994

0.002

6.098

  1. *0.000 means that the value is lower than 0.001.
  2. Response: ‘+’ (positive); ‘−’ (negative).
  3. N/A: Not available.
  4. Calibration curves determined by four-parameter linear regression. R2 (Coefficient of determination), LOD (Limit of detection), % CV (% Constant of variation).