Table 1 Open in new tab Negative...

	Assays	Pre-December 2019 %NA (95% CI) Negative/n	NAAT-negative %NA (95% CI)	Overall % NA (95% CI)
Positive = Positive and Equivocal results	Abbott IgG	99.3 (97.6–99.2) 297/299	98.9 (96.7–101.0) 93/94	99.2 (98.4–100.0) 390/393	100.0 (91.2–100.0) 40/40	99.3 (98.0–99.9) 430/433
Beckman IgG	100.0 (98.7–100.0) 292/292	98.9 (96.8–101.0) 91/92	99.7 (99.2–100.2) 383/384	100.0 (91.2–100.0) 40/40	99.8 (98.7–100.0) 423/424
DiaSorin IgG	98.7 (96.6–99.6) 294/298	96.8 (93.3–100.4) 91/94	98.5 (96.9–99.5) 385/392	100.0 (91.2–100.0) 40/40	98.4 (97.2–99.6) 425/432
Roche Total	99.7 (98.2–100.0) 298/299	100.0 (98.8–100.0) 299/299	99.7 (99.2–100.2) 392/393	100.0 (91.2–100.0) 40/40	99.8 (99.3–100.2) 432/433
Bio-Rad Total	99.3 (97.6–99.9) 297/299	98.9 (96.7–101.0) 93/94	99.2 (98.4–100.0) 390/393	100.0 (91.2–100.0) 40/40	99.3 (98.0–99.9) 430/433
EU IgG	97.7 (95.2–99.1) 292/299	97.9 (95.0–100.8) 92/94	97.7 (96.9–99.5) 384/393	95.0 (88.2–101.8) 38/40	97.5 (95.5–98.7) 422/433
EU IgA	80.6 (75.7–84.9) 241/299	84.0 (76.6–91.4) 79/94	81.4 (77.6–85.3) 320/393	62.5 (47.5–77.5) 25/40	79.7 (75.9–83.5) 345/433
Positive = Positive results	Bio-Rad Total	*99.7 (98.2–100.0)* *298/299*	98.9 (96.7–101.0) 93/94	*99.5 (98.8–100.2)* *391/393*	100.0 (91.2–100.0) 40/40	*99.5 (98.9–100.2)* *431/433*
EU IgG	*98.7 (96.6–99.6)* *295/299*	97.9 (95.0–100.8) 92/94	*98.5 (96.7–99.4)* *387/393*	95.0 (88.2–101.8) 38/40	*98.2 (96.4–99.2)* *425/433*
EU IgA	*83.3 (78.6–87.3)* *249/299*	*88.3 (80.0–94.0)* *83/94*	*84.7 (81.2–88.3)* *332/393*	*67.5 (53.0–82.0)* *27/40*	*82.9 (79.4–86.5)* *359/433*

Assays

Pre-December 2019 %NA (95% CI) Negative/n

NAAT-negative
%NA (95% CI)

Overall % NA (95% CI)

Non cross-reactivity

Cross-reactivity

Total

Positive = Positive and Equivocal results

Abbott IgG

99.3 (97.6–99.2) 297/299

98.9 (96.7–101.0) 93/94

99.2 (98.4–100.0) 390/393

100.0 (91.2–100.0) 40/40

99.3 (98.0–99.9) 430/433

Beckman IgG

100.0 (98.7–100.0) 292/292

98.9 (96.8–101.0) 91/92

99.7 (99.2–100.2) 383/384

100.0 (91.2–100.0) 40/40

99.8 (98.7–100.0) 423/424

DiaSorin IgG

98.7 (96.6–99.6) 294/298

96.8 (93.3–100.4) 91/94

98.5 (96.9–99.5) 385/392

100.0 (91.2–100.0) 40/40

98.4 (97.2–99.6) 425/432

Roche Total

99.7 (98.2–100.0) 298/299

100.0 (98.8–100.0) 299/299

99.7 (99.2–100.2) 392/393

100.0 (91.2–100.0) 40/40

99.8 (99.3–100.2) 432/433

Bio-Rad Total

99.3 (97.6–99.9) 297/299

98.9 (96.7–101.0) 93/94

99.2 (98.4–100.0) 390/393

100.0 (91.2–100.0) 40/40

99.3 (98.0–99.9) 430/433

EU IgG

97.7 (95.2–99.1) 292/299

97.9 (95.0–100.8) 92/94

97.7 (96.9–99.5) 384/393

95.0 (88.2–101.8) 38/40

97.5 (95.5–98.7) 422/433

EU IgA

80.6 (75.7–84.9) 241/299

84.0 (76.6–91.4) 79/94

81.4 (77.6–85.3) 320/393

62.5 (47.5–77.5) 25/40

79.7 (75.9–83.5) 345/433

Positive = Positive results

Bio-Rad Total

99.7 (98.2–100.0) 298/299

98.9 (96.7–101.0) 93/94

99.5 (98.8–100.2) 391/393

100.0 (91.2–100.0) 40/40

99.5 (98.9–100.2) 431/433

EU IgG

98.7 (96.6–99.6) 295/299

97.9 (95.0–100.8) 92/94

98.5 (96.7–99.4) 387/393

95.0 (88.2–101.8) 38/40

98.2 (96.4–99.2) 425/433

EU IgA

83.3 (78.6–87.3) 249/299

88.3 (80.0–94.0) 83/94

84.7 (81.2–88.3) 332/393

67.5 (53.0–82.0) 27/40

82.9 (79.4–86.5) 359/433

	Assays	Pre-December 2019 %NA (95% CI) Negative/n	NAAT-negative %NA (95% CI)	Overall % NA (95% CI)
Positive = Positive and Equivocal results	Abbott IgG	99.3 (97.6–99.2) 297/299	98.9 (96.7–101.0) 93/94	99.2 (98.4–100.0) 390/393	100.0 (91.2–100.0) 40/40	99.3 (98.0–99.9) 430/433
Beckman IgG	100.0 (98.7–100.0) 292/292	98.9 (96.8–101.0) 91/92	99.7 (99.2–100.2) 383/384	100.0 (91.2–100.0) 40/40	99.8 (98.7–100.0) 423/424
DiaSorin IgG	98.7 (96.6–99.6) 294/298	96.8 (93.3–100.4) 91/94	98.5 (96.9–99.5) 385/392	100.0 (91.2–100.0) 40/40	98.4 (97.2–99.6) 425/432
Roche Total	99.7 (98.2–100.0) 298/299	100.0 (98.8–100.0) 299/299	99.7 (99.2–100.2) 392/393	100.0 (91.2–100.0) 40/40	99.8 (99.3–100.2) 432/433
Bio-Rad Total	99.3 (97.6–99.9) 297/299	98.9 (96.7–101.0) 93/94	99.2 (98.4–100.0) 390/393	100.0 (91.2–100.0) 40/40	99.3 (98.0–99.9) 430/433
EU IgG	97.7 (95.2–99.1) 292/299	97.9 (95.0–100.8) 92/94	97.7 (96.9–99.5) 384/393	95.0 (88.2–101.8) 38/40	97.5 (95.5–98.7) 422/433
EU IgA	80.6 (75.7–84.9) 241/299	84.0 (76.6–91.4) 79/94	81.4 (77.6–85.3) 320/393	62.5 (47.5–77.5) 25/40	79.7 (75.9–83.5) 345/433
Positive = Positive results	Bio-Rad Total	*99.7 (98.2–100.0)* *298/299*	98.9 (96.7–101.0) 93/94	*99.5 (98.8–100.2)* *391/393*	100.0 (91.2–100.0) 40/40	*99.5 (98.9–100.2)* *431/433*
EU IgG	*98.7 (96.6–99.6)* *295/299*	97.9 (95.0–100.8) 92/94	*98.5 (96.7–99.4)* *387/393*	95.0 (88.2–101.8) 38/40	*98.2 (96.4–99.2)* *425/433*
EU IgA	*83.3 (78.6–87.3)* *249/299*	*88.3 (80.0–94.0)* *83/94*	*84.7 (81.2–88.3)* *332/393*	*67.5 (53.0–82.0)* *27/40*	*82.9 (79.4–86.5)* *359/433*

Table 1

Open in new tab

Negative agreement (NA) performance for serological assays.

	Assays	Pre-December 2019 %NA (95% CI) Negative/n			NAAT-negative %NA (95% CI)	Overall % NA (95% CI)
	Assays	Non cross-reactivity	Cross-reactivity	Total	NAAT-negative %NA (95% CI)	Overall % NA (95% CI)
Positive = Positive and Equivocal results	Abbott IgG	99.3 (97.6–99.2) 297/299	98.9 (96.7–101.0) 93/94	99.2 (98.4–100.0) 390/393	100.0 (91.2–100.0) 40/40	99.3 (98.0–99.9) 430/433
	Beckman IgG	100.0 (98.7–100.0) 292/292	98.9 (96.8–101.0) 91/92	99.7 (99.2–100.2) 383/384	100.0 (91.2–100.0) 40/40	99.8 (98.7–100.0) 423/424
	DiaSorin IgG	98.7 (96.6–99.6) 294/298	96.8 (93.3–100.4) 91/94	98.5 (96.9–99.5) 385/392	100.0 (91.2–100.0) 40/40	98.4 (97.2–99.6) 425/432
	Roche Total	99.7 (98.2–100.0) 298/299	100.0 (98.8–100.0) 299/299	99.7 (99.2–100.2) 392/393	100.0 (91.2–100.0) 40/40	99.8 (99.3–100.2) 432/433
	Bio-Rad Total	99.3 (97.6–99.9) 297/299	98.9 (96.7–101.0) 93/94	99.2 (98.4–100.0) 390/393	100.0 (91.2–100.0) 40/40	99.3 (98.0–99.9) 430/433
	EU IgG	97.7 (95.2–99.1) 292/299	97.9 (95.0–100.8) 92/94	97.7 (96.9–99.5) 384/393	95.0 (88.2–101.8) 38/40	97.5 (95.5–98.7) 422/433
	EU IgA	80.6 (75.7–84.9) 241/299	84.0 (76.6–91.4) 79/94	81.4 (77.6–85.3) 320/393	62.5 (47.5–77.5) 25/40	79.7 (75.9–83.5) 345/433
Positive = Positive results	Bio-Rad Total	*99.7 (98.2–100.0)* *298/299*	98.9 (96.7–101.0) 93/94	*99.5 (98.8–100.2)* *391/393*	100.0 (91.2–100.0) 40/40	*99.5 (98.9–100.2)* *431/433*
	EU IgG	*98.7 (96.6–99.6)* *295/299*	97.9 (95.0–100.8) 92/94	*98.5 (96.7–99.4)* *387/393*	95.0 (88.2–101.8) 38/40	*98.2 (96.4–99.2)* *425/433*
	EU IgA	*83.3 (78.6–87.3)* *249/299*	*88.3 (80.0–94.0)* *83/94*	*84.7 (81.2–88.3)* *332/393*	*67.5 (53.0–82.0)* *27/40*	*82.9 (79.4–86.5)* *359/433*

	Assays	Pre-December 2019 %NA (95% CI) Negative/n			NAAT-negative %NA (95% CI)	Overall % NA (95% CI)
	Assays	Non cross-reactivity	Cross-reactivity	Total	NAAT-negative %NA (95% CI)	Overall % NA (95% CI)
Positive = Positive and Equivocal results	Abbott IgG	99.3 (97.6–99.2) 297/299	98.9 (96.7–101.0) 93/94	99.2 (98.4–100.0) 390/393	100.0 (91.2–100.0) 40/40	99.3 (98.0–99.9) 430/433
	Beckman IgG	100.0 (98.7–100.0) 292/292	98.9 (96.8–101.0) 91/92	99.7 (99.2–100.2) 383/384	100.0 (91.2–100.0) 40/40	99.8 (98.7–100.0) 423/424
	DiaSorin IgG	98.7 (96.6–99.6) 294/298	96.8 (93.3–100.4) 91/94	98.5 (96.9–99.5) 385/392	100.0 (91.2–100.0) 40/40	98.4 (97.2–99.6) 425/432
	Roche Total	99.7 (98.2–100.0) 298/299	100.0 (98.8–100.0) 299/299	99.7 (99.2–100.2) 392/393	100.0 (91.2–100.0) 40/40	99.8 (99.3–100.2) 432/433
	Bio-Rad Total	99.3 (97.6–99.9) 297/299	98.9 (96.7–101.0) 93/94	99.2 (98.4–100.0) 390/393	100.0 (91.2–100.0) 40/40	99.3 (98.0–99.9) 430/433
	EU IgG	97.7 (95.2–99.1) 292/299	97.9 (95.0–100.8) 92/94	97.7 (96.9–99.5) 384/393	95.0 (88.2–101.8) 38/40	97.5 (95.5–98.7) 422/433
	EU IgA	80.6 (75.7–84.9) 241/299	84.0 (76.6–91.4) 79/94	81.4 (77.6–85.3) 320/393	62.5 (47.5–77.5) 25/40	79.7 (75.9–83.5) 345/433
Positive = Positive results	Bio-Rad Total	*99.7 (98.2–100.0)* *298/299*	98.9 (96.7–101.0) 93/94	*99.5 (98.8–100.2)* *391/393*	100.0 (91.2–100.0) 40/40	*99.5 (98.9–100.2)* *431/433*
	EU IgG	*98.7 (96.6–99.6)* *295/299*	97.9 (95.0–100.8) 92/94	*98.5 (96.7–99.4)* *387/393*	95.0 (88.2–101.8) 38/40	*98.2 (96.4–99.2)* *425/433*
	EU IgA	*83.3 (78.6–87.3)* *249/299*	*88.3 (80.0–94.0)* *83/94*	*84.7 (81.2–88.3)* *332/393*	*67.5 (53.0–82.0)* *27/40*	*82.9 (79.4–86.5)* *359/433*

EU, EUROIMMUN; n, sample size; CI, Confidence interval. Performance changes with the definition of 'positive=positive results' are bolded.

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