Sysmex UC-3500 and UF-5000 urine pipeline can quickly and effectively exclude bacterial urinary tract infection

doi:10.21203/rs.3.rs-1453006/v1

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Research Article

Sysmex UC-3500 and UF-5000 urine pipeline can quickly and effectively exclude bacterial urinary tract infection

https://doi.org/10.21203/rs.3.rs-1453006/v1

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Object

Aim to study the role of urine pipeline composed of Sysmex urine dry chemistry analyzer UC-3500 and urine particle analyzer UF-5000 in screening bacterial urinary tract infection (UTI).

Methods

We analyzed 2600 urine specimens from patients with suspected UTI using a urine dry chemistry analyzer (UC-3500) and a fully automated sediment analyzer (UF-5000). After the instruments test, all specimens were sent to our clinical microbiology laboratory with a culture request.

Results

The consistency of UF-5000 bacterial classification and bacterial culture was fair(kappa = 0.3387). The level of WBC, NIT, was raised with sequential group designs(P<0.001). The cut-off value of BACT was 104.80/µ L for males (AUC,0.956, 95%CI,0.936–0.976) and 705.50/µL for females (AUC,0.940, 95%CI,0.920–0.959). The Youden index, sensitivity, and specificity of BACT were relatively high, which were sufficient for diagnosing infection. All six schemes had good negative predictive value (NPV), and coincidence rate. The NPV of strategy② was 97.54%.

Conclusion

UF-5000 classification of bacteria can’t be used as a practical reference. 163.25/µL(male), 50.20/µL(female) for WBC and 104.80 /µL(male), 705.50 /µL(female) for BACT were used as cut off values, which could effectively determine whether UTI occurred. The single index BACT parameter is suitable for the rapid and effective exclusion of bacterial UTI.

UC3500

UF5000

urinary tract infection

screening

performance evaluation

Midstream urine culture test is the gold standard for urinary tract infection. However, bacterial culture and strain identification of drug sensitivity analysis requires substantial time for final reporting, usually 5-7days. So it can’t provide timely and effective information for clinical in the early stage of disease. If urinary tract infection is not treated in time, it will cause sepsis, uremia, renal failure and other serious consequences. Therefore, early diagnosis and timely treatment of urinary tract infection are vital (1, 2). Clinical doctors usually depend on the results of urine dry chemical analysis and urine formed element detection to predict whether urinary tract infection occurs or not, so as not to delay the best treatment time of patients, the instruments of Sysmex company, such as UF-500i and UF-1000i, have been proved to have excellent application value in screening urinary tract infection (3–5).

The urine pipeline is composed of urine dry chemistry analyzer UC-3500 and automated sediment analyzers UF-5000 produced by Sysmex Corporation in 2017.UF-5000 is based on fluorescence flow cytometry technology, just like UF-500i and UF-1000i. but significant changes have been made in the detection channel and reagents, and the light source has also been increased(6–8). It is worth noting that UF-5000 differs from UF-500i and UF-1000i, which only indicate “cocci” and “bacilli” in the alarm message of urinary tract infection. UF-5000 is an analyzer to detecting urine bacterium that can provide “Gram-positive bacteria” or “Gram-negative bacteria” (BACT)-info flag information. This alarm message provides more intuitive information for clinical work to identify the types of bacteria. At present, the performance of UF-5000 for rapid screening of urinary tract infection has been evaluated in many related studies in China and abroad. The results showed that UF-5000 could effectively screen the bacterial culture urine samples by selecting the appropriate cut-off value of white blood cell count and bacterial count. There was a significant concordance between the positive results of bacterial classification and bacterial culture(9–13). At present, there is little research on the comprehensive analysis and establishment of a perfect screening strategy.

Having this in mind, our study, combined with the urine pipeline formed by UF-5000 and UC-3500, established several screening strategies, evaluated the accuracy of UF-5000 bacterial classification, and further screened the appropriate screening strategy to provide more intuitive and transparent information for clinical treatment.

2.1 patients and urine specimens preparation

A total of 2600 suspected urinary tract infection (UTI) specimens were selected among hospitalized patients and outpatients from the department of nephrology, urology surgery, gynecology and obstetrics, pediatrics, geriatrics, general surgery, hematology, and ICU in Quanzhou First Hospital between November 2019 and August 2020. 1500(57.6%) of the specimens were males while 1100(42.4%) were females, all the whom were aged from 9 months to 97 years old, with a median age of 57.

2.2 Bacterial culture and strain identification

Quantitative urine cultures were performed using well-mixed specimens and a 10-ul calibrated loop on blood agar plates and Chinese blue plates. All plates were incubated at 37℃ in 5% CO2 for 48 hours at least. Classify the specimens according to whether bacteria have been cultivated or not. ①Bacteria were cultured within 48 hours, and there was ༞10⁴/ml bacterial growth, urine specimens marked as positive and recorded the number of colonies.②A specimen was considered negative if there was no growth or there was ༜10⁴/ml bacterial growth. ③More than three kinds of bacteria were cultured within 48 hours, and specimens marked as contamination. The positive colonies were further identified, and drug sensitivity was analyzed.

2.3 UF-5000 analysis and regent

All urine specimens were analyzed for (LEC), (NIT), white blood cell (WBC), and bacterial(BACT) using UC-3500 and UF-5000(Sysmex Corporation, Kobe, Japan) after inoculating the culture on the same day of collection and within two hours after the arrival in the laboratory. At the same time, record the bacterial classification results of suspicious UTI specimens.

The automatic bacteria identification and drug sensitivity system (phoebix100) were used for bacteria identification which was provided by BD company. Bacteria identification strips were provided by the original manufacturer. Blood agar plates and Chinese blue plates were provided by Dijing Microbial Technology Co., Ltd (China). CO2 incubator is the product of Thermo Fisher technology company (IGS 100)(America). Sysmex Corporation provided UF-5000 and UC-3500. Reagent, quality control material, and calibrator were provided by the instrument's original manufacturer and were used within the validity period. The devices had passed regular calibration and performance verification (including intra batch precision, inter batch precision, carryover rate, linear range, reportable range, etc.). The urine was detected after passing the quality control every day. The urine samples were tested after it was confirmed to meet the requirements of ISO 15189 and the manufacturer.

2.4 screening strategies of UTI

2.4.1 Methodology for Establishment of screening strategy

2000 samples were used to evaluate the accuracy of instrument test results and bacterial culture results, and calculate the cut-off value WBC, BACT in UF-5000 to judge UTI. Refer to the existing domestic and foreign UTI research literature about UF-5000 and UF-1000(14, 15). The value of WBC in UF-5000 is regarded as the positive value when it is greater than the cut-off value. The positive value of BACT is the same as WBC. The parameters of LEU, NIT, WBC, and BACT were combined to establish the following six screening programs. ①Only the value of WBC was positive(The value of WBC was more significant than the cut-off value).②Only the value of BACT was positive.③Both the value of WBC and BACT was positive.④The value of WBC, BACT and LEU were positive at the same time.⑤The values of WBC, BACT, and NIT were positive at the same time.⑥The values of WBC, BACT, LEU, and NIT were positive at the same time.

2.4.2 Verification and evaluation

Besides,600 samples were selected to evaluate the accuracy of the six screening strategies.

2.5 Statistical analysis

MedCalc19.0.7, SPSS20.0, and Microsoft Excel 2010 were used for statistical analysis. The results of bacterial counts and Gram-positive and Gram-negative discrimination of the UF-5000 were compared to urine culture results. Different definitions of negative urine samples were used according to the bacterial colony count levels: A group, a negative growth; B group, bacterial growth = 10⁴CFU/ml; C group, bacterial growth = 10⁵CFU/ml; Nonparametric Mann Whitney U test was used for comparison between groups. The Sysmex UF-5000 BACT and WBC count results were compared with the urine culture results using receiver operating characteristic (ROC) curve analysis. Kappa consistency test was used to analyze the consistency of UC-3500 Info flag information (LEU, NIT) and positive results of bacterial culture. To calculate the sensitivity, specificity, positive predictive value (PPV), and negative predictive value(NPV), Coincidence rate.

3.1 Urine culture results

Of the 2,600 urine cultures,425 bacterial culture samples were positive. Among positive samples,81.65%(347/425) were Gram-negative bacteria, 16.24%(69/425) were Gram-positive bacteria, and 2.12%(9/425) samples showed mixed flora.(Table 1.)

Table 1

Microorganisms identified in the 425 culture positive samples.
Microorganisms identified		n	%
G-	Escherichia coli	228	53.65
	Klebsiella pneumoniae ss pneumoniae	34	8.00
	Pseudomonas aeruginosa	19	4.47
	gardnerella vaginalis(Haemophilus vaginalis)	10	2.35
	Acinetobacter baumannii	9	2.12
	Klebsiella oxytoca	9	2.12
	Proteus mirabilis	8	1.88
	Enterobacter cloacae	7	1.65
	Acinetobacter baumannii/calcium acetate complex	4	0.94
	Escherichia coli + Pseudomonas aeruginosa	2	0.47
	Citrobacter Koseri	2	0.47
	Serratia marcescens.	2	0.47
	Escherichia col + Klebsiella pneumoniae ss pneumoniae	2	0.47
	Klebsiella pneumoniae ssp ozaenae	1	0.24
	Pseudomonas putida	1	0.24
	Citrobacter freundii	1	0.24
	Proteus penneri	1	0.24
	Stenotrophomonas maltophilia	1	0.24
	Aeromonas hydrophila	1	0.24
	Serratia liquefaciens	1	0.24
	Acinetobacter baumannii/calcium acetate complex + Klebsiella pneumoniae ss pneumoniae	1	0.24
	Acinetobacter baumannii/calcium acetate complex + Pseudomonas aeruginosa	1	0.24
	Salmonella enteritidis serotype + Stenotrophomonas maltophilia	1	0.24
	Serratia marcescens + Pandora agglomerata (Enterobacter agglomerata)	1	0.24
Total		347	81.65
G+	Enterococcus faecalis	34	8.00
	Enterococcus faecium	11	2.59
	Streptococcus agalactiae	8	1.89
	Corynebacterium glucosidolyticum	3	0.71
	Staphylococcus aureus	3	0.71
	Staphylococcus haemolyticus	3	0.71
	staphylococcus saprophyticus	1	0.24
	Corynebacterium urealyticum	1	0.24
	Enterococcus avium	1	0.24
	Staphylococcus hominis	1	0.24
	Actinomycetes Zurich	1	0.24
	Corynebacterium striatum	1	0.24
	Staphylococcus haemolyticus + Enterococcus faecalis	1	0.24
Total		69	16.24
G+/G-	Escherichia coli + Enterococcus faecalis	3	0.71
	Klebsiella pneumoniae subsp. Pneumoniae + Enterococcus faecium	3	0.71
	Baumannii / Acinetobacter calcoacetate complex + Staphylococcus aureus	1	0.24
	Staphylococcus aureus + Enterobacter cloacae	1	0.24
	Escherichia coli + Streptococcus agalactiae equi subsp	1	0.24
Total		9	2.12

3.2 UF-5000 performance at discriminating culture- positive and negative urine samples

Among 425 positive bacterial culture samples,331urine samples bacterial culture were positive, and UF-5000 bacterial classification indicates urinary tract infection either. Table 2 shows that the consistency of bacterial culture and bacterial taxonomy of UF-5000 was fair(Kappa = 0.339).

Table 2

Consistency evaluation of UF-5000 bacterial classification
UF-5000 bacterial classification	bacterial culture				Kappa	Z	P
UF-5000 bacterial classification	G+	G-	G+/G-	Total	Kappa	Z	P
G+	29	25	0	54	0.339	10.26	< 0.001
G-	1	198	4	203
G+/G-	6	59	6	71
Unclassified	0	3	0	3
Total	36	285	10	331

3.3 Accuracy evaluation of LEU and NIT

Urine culture was considered as the gold standard. The results showed that LEU and NIT had good negative predictive values (LEU:96.03%, NIT:91.08%). The consistency between NIT and bacterial culture was better than LEU (Kappa value = 0.566 and 0.277, respectively). (Table 3.)

Table 3

Accuracy evaluation of LEU and NIT
parameter	Sensitivity(%)	Specificity(%)	PPV(%)	NPV(%)	Coincidence rate(%)	Kappa
LEU	86.60	61.94	30.32	96.03	65.90	0.277
NIT	49.84	97.86	81.63	91.08	90.15	0.566

3.4 Comparison of WBC counts and the value of BACT

We compared WBC counts and the value of BACT among different bacterial species in specimens with negative growth(A group,1679 cases), bacterial growth = 10⁴CFU/ml (B group,57 cases), and bacterial growth = 10⁵CFU/ml(C group,264 cases). The results showed significant differences in WBC counts and the value of BACT among the three groups(P<0.05). And their levels gradually increased with the order of group A, B, and C. (Fig. 1A. 1B.)

3.5 ROC curve analysis

The ROC curves for the Sysmex UF-5000 BACT and WBC counts are shown in Fig. 2, in which culture results༞104CFU/ml were taken as the reference for significant bacteriuria. The Screening performance is offered at a cut-off of 163.25/µL (male),50.2/µL (female) for WBC, and 104.80/µL(male) 705.50/µL(female) for BACT, respectively. The area under the curve(AUC)for the WBC count is 0.859(95%CI = 0.826–0.891), which is lower than that for BACT count(0.956,95%CI = 0.936–0.976) in the male group. The area under the curve (AUC) for WBC count is 0.796(95%CI = 0.764–0.829), which is lower than that for BACT count(0.940,95%CI = 0.920–0.959) in the female group too. Meanwhile, the Youden index, sensitivity, specificity, and other indicators showed that the diagnostic value of BACT count was better than that of WBC count (Table 4).

Table 4

Diagnostic performance of UF-5000 at appropriate cut off value for WBC and BACT
parameter			cut off value (/µL)		SE	95%CI	Youden index	sensitivity (%)	Specificity (%)
WBC
		male	163.25	0.859	0.017	0.826–0.891	0.563	70.59	80.70
	female		50.20	0.796	0.017	0.764–0.829	0.480	83.78	64.21
BACT
	male		104.80	0.956	0.010	0.936–0.976	0.819	92.65	89.25
	female		705.50	0.940	0.010	0.920–0.959	0.757	84.32	91.37

3.6 Evaluation of screening strategy for urinary tract infection

All schemes had good negative predictive value(88.97%-93.54%) and coincidence rate(78.00%-89.17%). The sensitivity, Specificity, PPV, NPV, and coincidence rate of Single index screening strategy② was better than strategy①, but the PPV of combined screening indicators strategy③-⑥(66.99%-91.49%) was better than strategy②(60.78%). The PPV, NPV, coincidence rate of strategy⑤ and strategy⑥ were both approximately 90%, the specificity of them was close to 99.19%, but the sensitivity of them was low, only 41.35%. Table 5 showed the NPV of strategy② was the highest(97.54%), combined with other screening indicators, and it seems the best fit for the exclusion of bacterial urinary tract infection quickly and effectively.

Table 5

Performance evaluation of six screening programs
No.	screening strategy of UTI	sensitivity (%)	Specificity (%)	PPV (%)	NPV (%)	coincidence rate (%)
①	WBC+	74.04	78.83	42.31	93.54	78.00
②	BACT+	89.42	87.90	60.78	97.54	88.17
③	WBC+/BACT+	66.35	93.15	66.99	92.96	88.50
④	WBC+/BACT+/LEU+	66.35	93.95	69.70	93.01	89.17
⑤	WBC+/BACT+/NIT+	41.35	99.19	91.49	88.97	89.17
⑥	WBC+/BACT+/LEU+/NIT	41.35	99.19	91.49	88.97	89.17

In the present study, we confirmed that UC-3500 and UF-5000 urine pipeline could quickly and effectively exclude the possibility of bacterial UTI. The best cut-off value of WBC and BACT in UF-5000 were determined at the same time. We further chose the most suitable scheme for screening UTI (only BACT parameter was positive). Rapid screening of procedures can reduce unnecessary urine cultures and minimize the number of missed detections. Furthermore, the screening program effectively reduces waiting times for urine cultures.

Out of 2,600 urine specimens evaluated, 425 bacterial culture were positive(16.4%) for UTI and 2175 specimens were negative(83.6%).Of the 425 positives cultures,347 samples were Gram-negative bacteria(81.65%). Escherichia coli. was the most frequently identified Gram-negative bacteria(228/425,53.65%). Among the Gram-positive bacteria, Enterococcus faecalis. was the most frequently identified. 9 specimens were marked as contamination because both Gram-negative bacteria and Gram-positive bacteria were identified. These results indicated that Escherichia coli. were the major causative agent of UTI in this area. And this is consistent with mohnarin’s annual report on continuous monitoring of bacterial resistance in urine samples in recent years. There was no significant difference in the distribution of positive bacterial infections. (16, 17).It is different from Sysmex urine analyzer UF-500i and UF-1000i. The UF-5000 has been developed for improved performance for classification of Gram-Neg, Gram-Pos, Gram-Neg / Gram-Pos, and unclassified. UF-1000i classified bacteria as either “ords” or “cocci/mixed”, not Gram-Neg, Gram-Pos bacteria. Compared with UF-1000i, the ability of the new BACT Info flag of UF-5000 is more significant for clinical treatment.

The thresholds of WBC and BACT Info flag information with UTI provided by the Sysmex corporation were 10 /µL and100 /µL. However, these thresholds were lower than the reference range of the instrument(18). The laboratory can modify and set the threshold independently, so our laboratory set higher thresholds of Info flag information(WBC,30 /µL, BACT,300 /µL). Therefore, in this study, we evaluated the accuracy of Gram-positive bacteria and Gram-negative bacteria instead of the accuracy of Info flag information in instrument to determine UTI or not. The results showed that the consistency between Info flag information of instrument and positive results of bacterial culture was fair(Kappa = 0.339).Thus, UF-5000 Info flag information can’t be used as a clinical reference for bacterial classification. This conclusion is different from that of Ren, Du et al. They believe that the consistency between Info flag information of instrument and bacterial culture's positive results was substantial (Kappa = 0.775 or 0.724)(13–20).We analyze the reasons for the different conclusions in recent research, the instrument's status, the number of specimens, and the distribution of bacterial species in other laboratories, making it difficult to interpret two different conclusions. However, few studies focus on this question, so this conclusion needs to be further analyzed by expanding the specimens.

Urine culture was considered as the gold standard, the accuracy of LEU and NIT were evaluated, the results showed that LEU and NIT had good negative predictive value(LEU,96.03%, NIT,91.08%). This conclusion suggested that the negative results of LEU and NIT were helpful for clinicians to exclude urinary tract infection quickly. Sagbo and Pandey have the same viewpoint in their researches. Other parameters showed the PPV(30.32%) and coincidence rate(kappa = 0.277) of LEU, the sensitivity(49.84%) and coincidence rate(kappa = 0.566) of NIT were unsatisfactory. Therefore, it is thought that a single parameter (LEU or NIT) was not an effective detection parameter to judge UTI or not. In clinical diagnosis and treatment, they need to be combined with UF-5000 WBC and BACT to judge UTI more accurately.

According to the number of colonies, the positive results can be divided into10⁴ CFU/ml and 10⁵ CFU/ml. Therefore, in this experiment, the urine samples were divided into three groups (A. a negative growth, B. bacterial growth = 10⁴CFU/ml, C. bacterial growth = 10⁵CFU/ml). Compared the level of WBC and BACT in three groups, data showed that there were significant differences among all the groups(P༜0.01). Further analyses indicated that the lowest level of WBC and BACT was found in the A group, while the highest level was found in the C group. The level of WBC and BACT increases with the number of bacterial colonies. This conclusion is similar to previous studies (Kim SY. 2018; Liao.2020) (11, 21). The results showed a high consistency among WBC, BACT, and the number of bacterial colonies. Clinicians can preliminarily judge the bacterial content of UTI by the level of WBC and BACT, and these results may act as a reference for clinical anti-infection treatment.

Different reference ranges of WBC and BACT were set for males and females by different urine sediment analyzers and conventional microscopic examinations. It could probably be due to the physiological structure is different in males and females (18, 19, 22).

As a consequence, we also constructed ROC curves using only information regarding sex (12, 23). Furthermore, different cut-offs were used for judging UTI, the cut-off values of WBC were 163.25 /µL for males (AUC,0.859, 95%CI,0.826–0.891) and 50.20 /µL for females (AUC,0.796, 95%CI,0.764–0.829), the cut off value of BACT were 104.80/µ L for males (AUC,0.956, 95%CI,0.936–0.976) and 705.50/µL for females (AUC,0.940, 95%CI,0.920–0.959). Two of them have a high predictive value for UTI, but the Youden index, sensitivity, and specificity of BACT were relatively high, which were sufficient for diagnosing infection. The cut-off value of BACT was different from Rosa’s research. Cut off = 58 /µL was used to screen urinary tract infection (12). Participants in the study believed that instrument status, regional differences contributed to different conclusions. Consequently, different laboratories should set their cut-off value.

As mentioned earlier, LEU, NIT in combination with WBC, BACT in order to successfully determine whether UIT. In our study, the value of WBC and BACT in UF-5000 were regarded as positive values when they were more significant than the cut-off value. Thus, we established six UTI screening programs. The bacterial culture results were used for performance evaluation. All schemes had good negative predictive value and coincidence rate. Each evaluating indicator of Single index screening strategy② was better than strategy①, the PPV of strategy③-⑥(66.99%-91.49%) was better than strategy②. The PPV, NPV, and coincidence rate of strategy ⑤ and strategy ⑥ were about 90%. The specificity achieved 99.19%, but the result showed low sensitivity for screening UTI of only 41.35%. For clinical work, excluding patients with suspected UTI quickly and effectively could be more valuable than screening out specimens of UTI. Concerning this, PPV is the primary index of exclude patients with suspected UTI. So, in our opinion, although the strategy⑤ and strategy⑥ can screen UTI patients nearly 100%, it is not suitable for clinical work. strategy②is more suitable (PPV,97.54%). However, other more appropriate screening programs may be chosen dependent on different clinical needs.

Although UF-5000 has been reformed in the classification of bacteria, it can not be used as a practical reference. The accuracy of LEU and NIT in the diagnosis of urinary tract infection is lacking. However, 163.25/µL(male), 50.20/µL(female) for WBC and 104.80 /µL(male), 705.50 /µL(female) for BACT were used as cut off values, which could effectively determine whether urinary tract infection occurred. Finally, among the six screening programs established in this study, the single index BACT parameter is suitable for the rapid and effective exclusion of bacterial UTI.

Ethics approval and consent to participate

The study was performed in accordance with the Declarations of Helsinki.

This study protocol was reviewed and informed by the ethics committee of Quanzhou First Hospital, Fujian & Quanzhou First Hospital Affiliated to Fujian Medical University, approval number【2019】No.163.

Informed consent was obtained from all participants and from the parents and/or legal guardians for minor participants.

Consent for publication

Not applicable.

Availability of data and materials

The data used to support the findings of this study are included within the article. The data and materials in the current study are available from the corresponding author on reasonable request.

Conflict of Interest Statement

The authors declare that they have no competing interests.

Funding

Not applicable.

Authors' contributions

Conceptualization: Yabin Chen

Data collection: Zhishan Zhang, Wanni Wang, Yan Zhu, Jiaming Li

Data analysis: Yanjun Diao, Gangqiang Wang, Yuan Zhao

Draft: Zhenzhong Lin, Yibo Wu

Writing – review & editing: Yabin Chen, Zhishan Zhang, Jing Jing

Acknowledgements

Not applicable.

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Sysmex UC-3500 and UF-5000 urine pipeline can quickly and effectively exclude bacterial urinary tract infection

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Abstract

Figures

1. Introduction

2. Material And Methods

2.1 patients and urine specimens preparation

2.2 Bacterial culture and strain identification

2.3 UF-5000 analysis and regent

2.4 screening strategies of UTI

2.4.1 Methodology for Establishment of screening strategy

2.4.2 Verification and evaluation

2.5 Statistical analysis

3 Result

3.1 Urine culture results

3.2 UF-5000 performance at discriminating culture- positive and negative urine samples

3.3 Accuracy evaluation of LEU and NIT

3.4 Comparison of WBC counts and the value of BACT

3.5 ROC curve analysis

3.6 Evaluation of screening strategy for urinary tract infection

4. Disscussion

5. Conclusion

Declarations

References

Additional Declarations

Status:

Version 1