Table 5.
Evaluation of performance of NIS for blood donor screening
| S. No. | Author | Reference method (automated hematology analyzer) | NIS device | Bias | Accuracy | Performance characteristics | Inference |
|---|---|---|---|---|---|---|---|
| 1 | Kim et al62 | LH500 Beckman Coulter | NBM 200 | +0.1 g/dL | ICC 0.69 | Sensitivity 38.6% and specificity 93.6% | Application for donor screening requires further evaluation of technique |
| 2 | Pinto et al67 | Cell-Dyn Ruby, Abbott Laboratories | NBM 200 | +0.2 g/dL | Median of percentage errors was below the reference method | – | Good method in terms of precision and feasibility for anemia screening of blood donors |
| 3 | Weinstein et al68 | Coulter LH-750 | NBM 200 | +0.1 g/dL | Mean absolute error 0.85 g/dL, and the SD of error 1.02 g/dL | Sensitivity 82% Specificity 88% | Hb measurements by NBM 200 were in good agreement with reference values |
| 4 | Al-Khabori et al69 | Abbott Cell-Dyn Sapphire hematology analyzer | Masimo Pronto-7 Pulse | +0.2 g/dL | Correlation coefficient 0.46 with reference and 0.78 for two CO- oximetry Hb measurements | – | CO-oximetry method validated for blood donor Hb screening |
| 5 | Ardin et al28 | Sysmex KX-21N | NBM 200 | −0.12±1.14 g/dL | 91.7% | – | NIS method suitable for donor screening as they might preserve existing or encourage first-time donors and also retain former donors to donate blood |
| Pronto-7 | −0.50±0.99 g/dL | 86.4% | |||||
| HemoSpect | −0.22±1.24 g/dL | 88.4% | |||||
| 6 | Baart et al64 | Sysmex XT-188i | NBM 200 | Males: +0.10±0.60 mmol/L | 91.2 | Sensitivity 12.1%, specificity 98.6%, PPV 43.8% and NPV 92.4% | Measurements with invasive devices showed stronger correlation and better agreement with venous values than NIS |
| Females: +0.19±0.65 mmol/L | 82.6 | Sensitivity 17.0%, specificity 94.6%, PPV 36.4% and NPV 86.2% | |||||
| HemoSpect | Males: −0.06±0.73 mmol/L | 88.4% | Sensitivity 3.5%, specificity 95.9%, PPV 7.1% and NPV 91.8% | ||||
| Females: −0.06±0.64 mmol/L | 83.7% | Sensitivity 10.8%, specificity 95.0%, PPV 25% and NPV 87.4% | |||||
| 7 | Belardinelli et al63 | Beckman Coulter | NBM 200 | +0.29±0.98 g/dL | 88% | Sensitivity 98% and specificity 97% | Low correlation between NIS and laboratory Hb measurement |
| Pronto-7 | −0.53±1.04 g/dL | 78% | Sensitivity 93% and specificity 83% | ||||
| 8 | Sumnig et al65 | Siemens Advia 2120i | Pronto-7 | −5.9 g/L* | 74.75% | Sensitivity 63.2%, specificity 76.2%, PPV 24.8%, NPV 94.3% and CV 2.73% | NIS reasonable first-line approach for pre-donation Hb screening of blood donors |
| 9 | Singh et al21 | SysmexKX-21 | NBM 200 | −0.66 g/dL | ICC 0.43 | Sensitivity 71.1%, specificity 79.5%, PPV 30.2%, NPV 95.8% and CV 4.28% | NIS not effective in excluding ineligible donors, which may pose a threat to donors’ health |
Note: Data presented as mean ± standard deviation.
Abbreviations: ICC, intraclass correlation coefficient; NIS, noninvasive spectrophotometry; SD, standard deviation; Hb, hemoglobin; CV, coefficient of variation; PPV, positive predictive value; NPV, negative predictive value.