Table 2

Published studies conducted to validate the NBM 200 sensor

RefFirst author, year of publicationStudy settingsCountry, population and sample sizeMethod of comparison and gold standard usedNBM 200 performance
1Gayat, 2012Emergency department, Foch university hospital, Suresnes, FranceFrance
Patients reporting to the emergency department
n=569 and for
NBM 200 n=297 (men 157 and women 140)
Males 52.9%
Females 47.1%
Data analysed for 270 patients
Descriptive data, student t test, Bland-Altman analysis, intraclass correlation, multivariate linear regression to identify variables associated with bias
ADVIA 2120 (Siemens Medical Solutions Diagnostics, Zurich, Switzerland)
Bias: 0.21 g/dL (95% CI 0.02 to 0.39)
Bland-Altman analysis
Upper limit of agreement (ULA): 3.42 g/dL (95% CI 3.10 to 3.74)
Lower limit of agreement (LLA): −3.01 g/dL (95% CI −3.32 to −2.69)
Intraclass correlation coefficient: 0.69 (95% CI 0.62 to 0.75)
Coefficient of variation (CV): 5.9%
True values of haemoglobin (Hb) and perfusion index were independently associated with NBM 200.
Despite the limited bias, a wide level of agreement was found; thus, clinical usefulness is debatable
5Singh, 2015Blood donation centre in tertiary care institute, IndiaIndia
Blood donors
n=534, and 485 included in the analysis for NBM 200 (men 455, women 30)
Males 94%
Females 6%
Bland-Altman analysis, intraclass correlation coefficient, specificity, sensitivity, negative predictive value (NPV) and positive predictive value (PPV).
Sysmex KX-21 (Sysmex Corporation, Kobe, Japan)
Mean Hb by NBM 200:14.8 g/dL
Mean Hb by the gold standard: 14.1 g/dL
SD for NBM 200 >2.0 g/dL, on comparing with the gold standard.
Bland-Altman agreement
ULA: 2.09 g/dL (95% CI 1.88 to 2.30)
LLA : −3.39 g/dL (95% CI −3.61 to −3.19)
Bias: −0.66 g/dL (95% CI −0.78 to −0.53)
Sensitivity 71.7%, specificity 79.5%,
NPV 95.8%, PPV 30.2%
Intraclass correlation: 0.43 (95% CI 0.27 to 0.55)
NBM 200 did not detect 45.5% of ineligible donors.
NBM 200 has benefit of pain elimination but carries a substantial possibility of ineligible donor selection
6Malukani, 2014Blood donation centre in tertiary care hospital, Ahmedabad, Gujarat, IndiaIndia
Blood donors
n=200 (men 192, women 8)
Males 96%
Females 4%
Specificity, sensitivity, NPV and PPV.
Sysmex KX 21 (Sysmex America Inc., Lincolnshire)
Mean Hb by NBM 200: 13.5 g/dL (SD 1.4)
Sensitivity 96.36%, Specificity 91.43%,
NPV 84.21%, PPV 98.15%
Likelihood ratio 8.22
The results by NBM 200 showed wide variation when compared with the gold standard, but the mean of difference was non-significant
8Hadar, 2012Women's hospital, Rabin Medical centre, Petah Tikva, IsraelIsrael
Pregnant women
Average age 31.3 years
(range 21–25)
Average gestational age 35.9 weeks (range 13–41 weeks)
Bland-Altman analysis
LH750 automated haematology analyser (Beckman Coulter Inc., Brea, California, USA)
Hb range obtained by NBM 200: 7.7 g/dL–14.0 g/dL
SD 0.86 g/dL
Bland-Altman agreement: −1.59 g/dL to 1.79 g/dL
Correlation coefficient: 0.82
Mean absolute error: 0.71 g/dL
Hb range obtained by gold standard: 6.9 g/dL–13.9 g/dL
Study demonstrates good correlation with the gold standard and NBM 200 measures Hb accurately
12Ardin, 2015Blood donation centre of the Institute for Transfusion Medicine of the University Hospital of Cologne, GermanyGermany
Blood donors
Donors age mean 36 years (SD 14)
n=351, and for
NBM 200
n=120 (through phase 1 of the study, 78 men and 42 women)
Men 65%
Women 35%
Bland-Altman analysis
Sysmex KX-21n, (Sysmex Europe GmbH, Norderstedt, Germany)
SD for NBM 200 1.14 g/dL, on comparing with the gold standard
Bland-Altman agreement: −2.35 g/dL to 2.11 g/dL
Bias: −0.12 g/dL
False rejection of seven donors, however, no correspondent unacceptable classification occurred
NBM 200 obtained lower Hb levels in women
13Kim, 2013Two blood donation sites affiliated to the Hanmaum Blood centre, Gwacheon, KoreaKorea
Blood donors
n=506 (men 291, women 215)
Males 57.5%
Females 42.4%
Bland-Altman analysis, Specificity and Sensitivity.
LH500 automated haematology analyser (Beckman Coulter Inc., Brea, California, USA)
Mean Hb by NBM 200: 14.1 g/dL
Intraclass correlation between NBM 200 and LH500: 0.86
NBM 200
Hb <12.0 g/dL in 37 participants (mean 12.4, SD 1.2)
Hb=12.0 to 12.4 g/dL in 18 participants (mean 12.8, SD 1.1)
Hb ≥12.5 g/dL in 451 participants (mean 14.4, SD 1.2)
Bland-Altman plot showed 2 SD difference in Hb estimations between LH500 and NBM 200, Hb >2.0 g/dL.
Whole blood
Sensitivity 38.6% (95% CI 28.1% to 50.3%)
Specificity 93.6% (95% CI 90.9% to 95.5%)
Sensitivity 37.8% (95% CI 24.1% to 53.9%)
Specificity 94.0% (95% CI 91.5% to 95.8%)
Out of 70 ineligible donors (Hb <12.5 g/dL) according to the gold standard (LH500), 43 donors (61.45%) were considered eligible by NBM 200
14Pagliaro, 2014Immunohematology and Transfusion Medicine Collection site of S. Orsola Malpighi Hospital, Bologna, ItalyItaly
Blood donors
Data from year 2012
NBM 200 (n)
Data from year 2013 (n)
NBM 200
Specificity, sensitivity, NPV and PPV
Donors were classified into fit and unfit sections
Haematocytometry tests as a reference in the year 2012
Beckman Coulter's AcT-5 diff AL (Beckman Coulter Inc., Brea, California, USA) as a gold standard in the year 2013
2012: NBM 200 and Haematocytometry test
Women (n=1021)
Sensitivity 32.34%, specificity 95.12%,
NPV 85.15% and PPV 61.90%
Men (n=2945)
Specificity 98.89%, sensitivity 14.47%
NPV 95.30% and PPV 42.59%
2013: NBM 200+targeted venous sample (gold standard, Beckman Coulter)
Women (n=1100)
Sensitivity 45.76%, specificity 99.24%,
NPV 90.51% and PPV 92.05%
Men (n=2895)
Sensitivity 36.03%, specificity 99.93%,
NPV 96.94% and PPV 96.08%
Compared to non-invasive techniques, a venous sample improves donor selection
15Belardinelli, 2013Immunohematology and Transfusion Medicine Collection site of S. Orsola Malpighi Hospital, Bologna, ItalyItaly
Blood donors
n=445 (men 296, women 149)
Males 66.5%
Females 33.4%
Bland-Altman analysis, Specificity and Sensitivity.
Beckman Coulter's AcT-5 diff AL (Beckman Coulter Inc., Brea, California, USA)
Bland-Altman agreement: −1.64 g/dL to 2.21 g/dL
Bias: 0.29 g/dL
SD: 0.98 g/dL
Percentage of donors screened correctly by NBM 200: 88%
Sensitivity 98%, specificity 97%
Non-invasive technique does not replicate results of the venous sample, and compared to finger-prick (HamoCue), the NBM 200 had low sensitivity and specificity