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Results Overview

Overview results from SKUP evaluations

SKUP strives for key information from our evaluations to be easily accessible. The overview tables below consist of limited, but important, information from our evaluations. For more information, see full report or summary from the evaluation of interest. The SKUP evaluations are in constant development, therefore it may be difficult to compare older reports with more recent reports.

Blood glucose systems for self-monitoring of blood glucose (SMBG)

The tables below consist of overview results from the 10 latest SKUP evaluations of SMBG systems, distributed in two tables. The evaluations assessed against the current and updated APSs are listed in the first table and earlier evaluations, assessed against older APSs, are listed in the second table. In Sweden, glucose meters should fulfil stricter quality goals when used in selected patient groups ^a. See full reports on whether results are within the stricter APS.

Evaluated against updated APS
SMBG system	Manufacturer	SKUP evaluation	Measurements performed by	Fulfilling APS for imprecision¹	Fulfilling APS for accuracy²	User-friendliness
Actiste	Brighter AB	2021/120	BLSs	No	No	Unsatisfactory
			People with diabetes	No	No
Accu-Chek Instant	Roche Diagnostics	2017/113	BLSs	Yes	Yes	Satisfactory
			People with diabetes	No	Yes
Accu-Chek Guide	Roche Diagnostics	2017/112	BLSs	Yes	Yes	Satisfactory
			People with diabetes	Yes	Yes
Accu-Chek Aviva	Roche Diagnostics	2014/105	BLSs	Yes	Yes	Satisfactory
			People with diabetes	Inconclusive	Yes
mylife Unio	Bionime Corporation	2013/100	BLSs	Yes	Yes	Satisfactory
			People with diabetes	Yes	Yes

¹APS for imprecision is CV ≤5 %.
²Minimum requirement: 95 % of the results within ±0,83 mmol/L of the average measured values of the reference measurement procedure at glucose concentrations <5,55 mmol/L or within ±15 % at glucose concentrations ≥5,55 mmol/L.

^ahttps://www.equalis.se/media/b2cj1rmk/pr008_eng_swedish-national-quality-goals-for-measurement-of-glucose_2018-12-10.pdf

Evaluated against previous APS
SMBG system	Manufacturer	SKUP evaluation	Measurements performed by	Fulfilling APS for imprecision¹	Fulfilling APS for accuracy²	User-friendliness
Accu-Chek Mobile	Roche Diagnostics	2013/99**	BLSs	Yes	Yes	Evaluated in SKUP/2009/74
Mendor Discreet	Mendor Oy	2012/95	BLSs	Yes	Yes	Inconclusive
Mendor Discreet	Mendor Oy	2012/95	People with diabetes	Inconclusive	Yes	Inconclusive
Contour XT	Bayer Healthcare	2012/94	BLSs	Yes	Yes	Satisfactory
Contour XT	Bayer Healthcare	2012/94	People with diabetes	Yes	Yes	Satisfactory
Accu-Chek Performa	Roche Diagnostics	2011/93³	BLSs	Yes	Yes	Satisfactory
OneTouch Verio	LifeScan, Johnson & Johnson	2011/86	BLSs	Yes	Yes	Inconclusive
OneTouch Verio	LifeScan, Johnson & Johnson	2011/86	People with diabetes	Yes	Yes	Inconclusive

¹APS for imprecision is a CV ≤5 %.
²Minimum requirement: 95 % of the results within ±0,83 mmol/L of the average measured values of the reference measurement procedure at glucose concentrations <5,55 mmol/L or within ±15 % at glucose concentrations ≥5,55 mmol/L.
³The evaluation was performed only by BLSs.

HbA1c

The results in the reports are presented in mmol/mol, with analytical performance specifications being calculated using IFCC%. Do note that the results are not directly comparable between all evaluations as the APSs have been updated over the years.

HbA1c system	Manufacturer	SKUP evaluation	Measurements performed by	Fulfilling APS for imprecision²	Fulfilling APS for accuracy	User-friendliness
cobas b 101 HbA1c	Roche Diagnostics	2022/129¹	Personnel in PHCC	Yes	No³	Inconclusive
Afinion 2 Analyzer HbA1c	Abbott Diagnostics Technologies	2021/126	BLSs	Yes	Yes³	Satisfactory
Afinion 2 Analyzer HbA1c	Abbott Diagnostics Technologies	2021/126	Personnel in PHCC	Yes	Yes³	Satisfactory
cobas b 101 HbA1c	Roche Diagnostics	2020/117	BLSs	Inconclusive	No⁴	Satisfactory
cobas b 101 HbA1c	Roche Diagnostics	2020/117	Personnel in PHCC	Yes	No⁴	Satisfactory
InnovaStar analyzer	DiaSys Diagnostic Systems	2014/101	BLSs	Yes	No⁵	Satisfactory
InnovaStar analyzer	DiaSys Diagnostic Systems	2014/101	Personnel in PHCC	Inconclusive	No⁵	Satisfactory
Quo-Test A1c	Quotient Diagnostics Ltd	2012/91	BLSs	Inconclusive	Yes⁵	Satisfactory
Quo-Test A1c	Quotient Diagnostics Ltd	2012/91	Personnel in PHCC	Inconclusive	Yes⁵	Satisfactory

¹Performed only by intended users, i.e., personnel in PHCCs.
²APS; Precision, calculated as repeatability, ≤3,0 CV%, except for Quo-Test A1c where it was ≤4,0 CV%.
³Minimum requirement: 95 % of the results within ±3,0 mmol/mol from the results of the comparison method at HbA1c concentration <35,3 mmol/mol and within ±8,5 % at HbA1c concentration ≥35,3 mmol/mol.
⁴ Minimum requirement: 95 % of the results within ±8,5 % from the results of the comparison method.
⁵ Minimum requirement: 95 % of the results within ±10 % from the results of the comparison method.

SARS-CoV-2 antigen rapid detection tests

Ag-RDT	Manufacturer	SKUP evaluation	Sample material	Fulfilling recommendation for sensitivity	Fulfilling recommendation for specificity	User-friendliness
MF-68 SARS CoV-2 Antigen Test	Shenzhen Microprofit Biotech Co. Ltd.	2022/131	Nasal	No	Yes	Satisfactory
Flowflex SARS-CoV-2 Antigen Rapid Test	Acon Biotech Hangzhou Co. Ltd.	2022/128	Nasal	No	Yes	Satisfactory
NADAL Covid-19 Ag Test	Naal von Minden GmbH	2022/125	Nasal	No	Yes	Satisfactory
Clinitest Rapid Covid-19 Antigen Test	Healgen Scientific Limited Liability company	2021/127	Naso-pharyngeal	No	Yes	Satisfactory
LumiraDx	LumiraDx UK Ltd.	2021/124	Naso-pharyngeal	Yes	Yes	Satisfactory
LumiraDx	LumiraDx UK Ltd.	2021/124	Nasal	Yes	Yes	Satisfactory

Streptococcus pyogenes (Strep A) rapid detection tests

RDT

Manufacturer

SKUP evaluation

Fulfilling performance requirement for sensitivity

Fulfilling performance requirement for specificity

User-friendliness

DIAQUICK Strep A Blue Dipstick

DIALAB GmbH

2018/114

Yes

Satisfactory

QuickVue Dipstick Strep A Test

Quidel Corporation

2015/107

Yes

Satisfactory

SKUP have performed nine evaluations at hospital laboratories only, using another evaluation protocol. Those rapid tests were not evaluated by the intended users, and no real patient samples were involved. Due to this, these evaluations are not presented on this page.

Abbreviations

Ag	Antigen
APS	Analytical performance specification
BLS	Biomedical laboratory scientist
CV	Coefficient of variation
PHCC	Primary health care center
RDT	Rapid detection test
SMBG	Self-monitoring of blood glucose
Strep A	Streptococcus pyogenes group A