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PRINSIP DAN FAKTOR-FAKTOR YG

MENGINTERFERENSI HASIL
POINT OF CARE TESTING (POCT)
Ira Puspitawati

SMF PK & KEDOKTERAN LABORATORIUM RSS


POINT OF CARE TESTING
 Point of care testing (POCT) is defined as “clinical
laboratory testing conducted close to the site of
patient care, typically by clinical personnel whose
primary training is not in the clinical laboratory
sciences or by patients (self-testing).

 POCT refers to any testing performed outside of


the traditional, core or central laboratory".
POINT OF CARE TESTING
 Two different aspects to POCT:
a. Monitoring
b. Screening.

 NOT SUFFICIENT FOR DIAGNOSTIC PURPOSE


POINT OF CARE TESTING

 Recommendation: There are no published data to


support a role for portable meters in the diagnosis
of diabetes or for population screening.
 The imprecision of the meters, coupled with the
substantial differences among meters, precludes
their use in the diagnosis of diabetes and limits their
usefulness in screening for diabetes.
 Level of evidence: E

(American Diabetes Association. Self-monitoring of blood glucose.


Diabetes Care 1996;19(Suppl 1):S62–6.)
POINT OF CARE TESTING

IVD: In Viitro Device; GMD : General Medical Device


WHY ?

 Hand-held glucose meters are routinely used for


measuring point of care (POCT) in special care
nurseries and emergency departments because of
their portability, immediacy of results, and minimal
blood volume requirements.
Praktis
Menggunakan alat yang portabel, mudah dibawa,
dapat dilakukan dimana saja.
Cepat
Sampel dengan volume sedikit  iatrogenic
anemia
 Relatif mudah dipergunakan.
 Kasus emergency  penanganan cepat
Memungkinkan untuk digunakan pasien untuk ‘self
monitoring’
KERUGIAN POCT

 Ketelitian dan ketepatan kurang dibandingkan


laboratory konvensional.
 Mutu tidak terkontrol.
 Faktor-faktor penganggu tidak diperhatikan.
(stabilitas reagen terhadap suhu dan kelembaban).
 Dilakukan oleh tenaga yang belum terlatih.
 Zat-zat yang menginterferensi
 Tidak ada pencatatan
KERUGIAN POCT

 Sistem tertutup untuk reagen tertentu


 Potensi menimbulkan kesalahan yang berdampak
fatal
 Keterbatasan parameter yang diperiksa.
 Kurangnya regulasi terkait pemakaian POCT
GLUCOSE METER
General Operation of the Glucose Meter
General Operation of the Glucose Meter

1. Set up meter with calibration chip for particular lot of strips


used
2. Insert Strip (Disposable Biosensor). This turns meter on and it
performs internal tests and applies voltage to cell.
3. Collect sample by touching drop of blood to strip opening
a. Blood fills chamber by capillary action.
b. Meter senses wetting (by drop in impedance), turns off
cell, and starts the incubation time.
General Operation of the Glucose Meter
c. The incubation time allows dissolution of chemicals,
enzymatic reaction to occur and solution to become
homogeneous.
d. When incubation time is completed, potential is applied so
that reacted mediator is converted back to original
oxidation state. The current is monitored, compared to a
calibration curve, and then concentration is reported.

Note: The strips used in BGM’s are very sensitive to light and
to excess moisture in the air  put a dessicant in the lid of
the strips or in the bottom of the bottle.
A dessicant is an object that absorbs moisture and retains
it.
Mechanism of Glucose Meters
Mechanism of Glucose Meters

1. Glucose first reacts with the enzyme glucose


dehyrogenase. Glucose is oxidized to gluconic acid
and the enzyme is temporarily reduced by two
electrons transferred from glucose to the enzyme.

2. The reduced enzyme next reacts with the mediator


(Mox), transferring a single electron to each of two
mediator ions. The enzyme is returned to its original
state, and the two Mox are reduced to Mred.
Mechanism of Glucose Meters

3. At the electrode surface, Mred is oxidized back to


Mox and the measured current is used to determine
the concentration of glucose in the sample.
Factors affecting glucose levels
 Type of methods or type of chemical analysis used
for the test
 The type of sample analyzed (whole blood verses
plasma)
 The source of the blood (venous, capillary, or
arterial)[
(ErikssonKF, Fex G, and Trell E: “Capillary-venous differences in blood glucose values during the oral
glucose tolerance test”, Clin Chem 1983;29(5):993.)
METHODS OF GLUCOSE POCT

1. Glucose dehydrogenase
pyrroloquinolinequinone (GDH-PQQ)

2. Glucose dehydrogenase nicotinamide adenine


dinucleotide (GDH-NAD)

3. Glucose oxidase, or glucose


hexokinase methods
METHODS OF GLUCOSE POCT

 Affected by elevated
levels of maltose
POCT SAMPLE
CAPILLARY VS VENOUS GLUCOSE
 Sampel darah kapiler komposisinya lebih menyerupai

komposisi darah arteri dibandingkan darah vena


(misalnya kadar glukosa dan oksigen).
 Variasi dalam sampling darah kapiler (finger

sampling technique) dan perubahan aliran darah


perifer dapat mempengaruhi komposisi darah
kapiler.
Eriksson KF, Fex G, and Trell E: “Capillary-venous differences in blood glucose
values during the oral glucose tolerance test”, Clin Chem 1983;29(5):993
CAPILLARY VS VENOUS GLUCOSE
CAPILLARY VS VENOUS GLUCOSE

 Korelasi yang cukup bagus antara kadar glukosa kapiler


dan glukosa vena (R= 0.80, 95% CI 0.77-0.82), namun
masih terdapat perbedaan rerata glukosa yang
bermakna antara glukosa kapiler dan glukosa vena
(134.1 vs. 122.7 mg/dl, respectively) (Srimaekarat,
2009).

 Kadar glukosa sample darah vena whole blood 7% lebih


rendah dibandingkan sampel darah kapiler pada
individu yang memiliki kadar glukosa normal. (Somogyi,
1948).
CAPILLARY VS VENOUS GLUCOSE

 Pada saat kondisi puasa, kadar glukosa darah kapiler


lebih dapat memprediksi kadar glukosa darah vena
secara reliabel pada semua subyek penelitian (Liu,
1992).

 Namun saat pasien diberikan glukosa (glucose loading)


didapatkan perbedaan kadar glukosa kapiler dan
vena yang tidak dapat diprediksi. Kadar glukosa vena
lebih rendah 2%-26% dibandingkan kapiler pada
saat 1 jam post loading glukosa (Liu, 1992)
Liu D, et al, Diabetologia 1992;35:287-290.
CAPILLARY VS VENOUS GLUCOSE

 Konversi secara umum adalah kadar glukosa darah


kapiler 7-8% lebih tinggi dibandingkan kadar
glukosa darah vena.
“Diabetics go home”, Lancet 1980;2:217.

 Penelitian lain menunjukkan rentang perbedaan


kadar glukosa vena dan kapiler antara 0-13%
tergantung pada kadar glukosa.
Alberti KGMM and Skrabalo Z: IDF Bull 1982;27:17-45.
SUBSTANCE INTEREFERENCE SAMPLE

• certain concentration levels


 inaccurately high results.
Acetaminophen • Concentration level 
varies  drug metabolism

Maltose • Glucose dehydrogenase


pyrroloquinolinequinone
Interference (GDH-PQQ) chemistry test
strips.
SUBSTANCE INTEREFERENCE SAMPLE

• Low hematocrit values 


an overestimation of
blood glucose.
• High hematocrit  Blood
viscosity >>  impaired
sample diffusion

http://www.nlm.nih.gov/medlineplus/print/ency/article/003646.htm
.
SUBSTANCE INTEREFERENCE SAMPLE

• High Dose Ascorbic Acid


 High False Positive
Result for Glucose
Oxidase Methods

Suryatmaja M, Puspa Dewi E, Dept of Clinical Patholohy FKUI 2003


Faktor yang mempengaruhi hasil POCT

Volume • Volume sampel yang tidak


adekuat  hasil rendah palsu 
Sampel squeezing

Penyimpanan • Reagen sangat peka thd


kelembaban dan suhu.
Reagen • Harus tertutup rapat

• Daya batere yang tidak adekuat


Electricity  hasil yang salah
Faktor yang mempengaruhi hasil POCT

Teknik • Kit must be insert properly  improperly


penggunaan insertion  low false negative result

• Too much squeezing or 'milking' of the


Teknik fingertip to produce a drop of blood may
sampling cause inaccuracies from either excess
tissue fluid or hemolysis (Rasaiah, 1985).

Penyampaian • Transcription error/communication failure)


hasil  not well recorded
Faktor yang mempengaruhi hasil POCT

Device • Ikuti petunjuk


specific penggunaan

Quality • Reagen kontrol


Control • QC  validitas hasil
GLUCOSE METER INDICATIONS

SELF MONITORING
POCT BLOOD GLUCOSE
(SMBG)

a) achieving and c) avoiding (e) determining


maintaining severe the need for
glycemic control hyperglycemia; initiating insulin
therapy in
b) preventing d) gestational
and detecting adjusting to diabetes mellitus
hypoglycemia; changes in (GDM)
lifestyle
SIMPULAN
 Banyak faktor yang dapat menginterferensi hasil
POCT  perlu pemahaman dan pelatihan bagi
pengguna POCT.
 Perlu regulasi dan standarisasi POCT.

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