PERBANDINGAN PENENTUAN RENTANG RUJUKAN (REFERENCE INTERVAL) PARAMETER HEMATOLOGI : Kajian Berbasis Rumah Sakit
DWI FERNIAWANTI, dr. Tri Ratnaningsih, M.Kes., Sp.PK(K).; Prof. dr. Budi Mulyono, MM, Sp.PK(K)
2016 | Tesis-Spesialis | SP ILMU PATOLOGI KLINIKPendahuluan: Data laboratorium selain untuk penegakan diagnosis, skrining, dan monitoring pasien, dapat juga untuk menetapkan rentang rujukan. Nilai parameter hematologi dipengaruhi oleh beberapa faktor seperti usia, jenis kelamin, ras, nutrisi, lingkungan, ketinggian, alat dan metode tes yang dipakai, oleh karena itu disarankan setiap laboratorium klinik menggunakan rentang rujukan sendiri yang sesuai dengan keadaan setempat. Rentang rujukan dapat ditetapkan melalui metode direk maupun indirek. Metode direk direkomendasikan oleh Clinical and Laboratory Standards Institute (CLSI)dan International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) dengan menggunakan subyek sehat, namun terdapat beberapa keterbatasan yakni membutuhkan banyak waktu, biaya dan tenaga. Perhitungan rentang rujukan metode indirek menggunakan data laboratorium yang telah tersedia. Penelitian ini bertujuan untuk membandingkan penentuan rentang rujukan metode direk dan indirek pada parameter hematologi yakni hemoglobin, hematokrit, trombosit, leukosit dan hitung jenis lekosit. Metode: Subyek penelitian melibatkan individu yang melakukan pemeriksaan kesehatan dan data sekunder pasien di laboratorium. Sampel darah diambil 7mL. Dua mL sampel darah dimasukkan dalam tabung EDTA untuk diperiksa parameter hematologi otomatik dengan alat hematology analyzer Sysmex XN1000 danKED. Lima mL sampel darah diambil serumnya untuk diperiksa GPT, GDP, Kolesterol total, Kreatinin, dan CRP secara kualitatif. Hasil: Penelitian dengan metode direk dilakukan pada 935 subyek yang melakukan tes kesehatan, didapatkan subyek yang memenuhi kriteria inklusi, tidak memenuhi kriteria eksklusi serta tidak sebagai outliers sejumlah 147 pria dan 181 wanita. Metode indirek menggunakan data dari alat selama 6 bulan, didapatkan 17.650 data pasien umur 18-60 tahun. Setelah disingkirkan adanya outliers, didapatkan data 4.100 pria dan 4.797 wanita. Data diolah menggunakan software statistik MedCalc, dengan metode persentil non parametrik (2.5 persentil - 97.5 persentil) menurut rekomendasi CLSI (C28-A3). Data yang didapat dari metode direk dan indirek untuk masing - masing jenis kelamin dilakukan uji beda menggunakan metode Harris Boyd (uji z). Didapatkan hasil pada subyek pria, pada parameter trombosit, leukosit, monosit, eosinofil,basofil tidak berbeda bermakna, akan tetapi pada hemoglobin, hematokrit,netrofil dan limfosit terdapat perbedaan yang bermakna antara kedua metode. Pada subyek wanita parameter hemoglobin,hematokrit, trombosit, leukosit, netrofil, monosit, eosinofil, basofil menunjukkan tidak adanya perbedaan yang bermakna, hanya limfosit yang berbeda bermakna antara rentang rujukan metode direk dan indirek. Kesimpulan: Rentang rujukan metode direk dan indirek dari penelitian ini beberapa parameter menunjukkan adanya perbedaan yang bermakna dan sebagian parameter yang lain tidak terdapat perbedaan yang bermakna. Penentuan rentang rujukan lebih direkomendasikan menggunakan metode direk, metode indirek dapat digunakan sebagai alternatif, bila sulit mendapatkan subyek sehat.
Introduction: Laboratory data in addition to help establish diagnosis, screening, and patient monitoring, it may also be used to establish reference interval. Hematological parameter values are influenced by several factors such as age, gender, ethnicity, nutritional status, environment, altitude, instruments and methods used for measurement. It is recommended for clinical laboratories to establish their own reference interval that fit with local situation. Reference interval can be estimated through direct or indirect methods. Direct method is recommended by Clinical and Laboratory Standards Institute (CLSI) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)by recruiting healthy subjects, but there are some limitations, it is time, cost and labor intensive. Reference interval calculation by indirect method using the bulk of provided laboratory data. This study objective was to compare reference interval determination for hematological parameters, i.e. hemoglobin, hematocrit, platelet, leukocyte and leukocyte differential counts using direct and indirect methods. Methods: The subjects involved individuals who had medical tests and patient data records that already stored in the laboratory. Blood samples of 7ml were taken. Two mL of blood sample were contained in EDTA tubes for hematological parametertests using automated hematology analyzer Sysmex XN-1000 and ESR. Five mL of blood samples had serum extracted for qualitative measurements of GPT, fasting glucose, total cholesterol, Creatinine, and CRP. Results: Direct method were performed on 935 subjects who had medical tests, from these, 122 men and 127 women met the inclusion and exclusion criteria, and not considered as outliers. Indirect method used data from instruments for six months, data were gathered from 17.650 patients aged between 18-60 years old. After observing outliers, data from 4.100 men and 4.797 women were remained. Collected data were analyzed using the statistical software MedCalc, with a nonparametric percentile method (2.5 percentile - 97.5 percentile) according to CLSI recommendations (C28-A3). The data from direct and indirect methods were then further analyzed for comparison using Harris Boyd method (z test). The results among male subjects found that between two methods, platelet, leukocyte, monocyte, eosinophil, basophil parameters were not significantly different, but hemoglobin, hematocrit, neutrophil and lymphocyte parameters were significantly different. Among female subjects, this study found that between two methods, hemoglobin, hematocrit, platelet, leukocyte, neutrophil, monocyte, eosinophil, basophil parameters showed no significant differences, only lymphocyte parameterwas significantly different. Conclusion This study between direct and indirect methods some parameters were significantly different and some parameters not significantly different. It is recommended to estimate reference ranges using direct methods; however, indirect methods can be used as an alternative, if it is difficult to recruit healthy subjects.
Kata Kunci : reference ranges, direct method, indirect method, hematological parameters
