Prinsip Poct Dan Faktor Yang Mempengaruhi Hasil Poct Final

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".
 Two different aspects to POCT:
a. Monitoring
b. Screening.
 NOT SUFFICIENT FOR DIAGNOSTIC PURPOSE

 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.)
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
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.
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
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.
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
 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).
 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.
 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.
• 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
.
• 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
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
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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PRINSIP DAN FAKTOR-FAKTOR YG

SMF PK & KEDOKTERAN LABORATORIUM RSS

 POCT refers to any testing performed outside of

 NOT SUFFICIENT FOR DIAGNOSTIC PURPOSE

 Recommendation: There are no published data to

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

IVD: In Viitro Device; GMD : General Medical Device

 Hand-held glucose meters are routinely used for

 Ketelitian dan ketepatan kurang dibandingkan

 Sistem tertutup untuk reagen tertentu

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

1. Glucose first reacts with the enzyme glucose

2. The reduced enzyme next reacts with the mediator

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

2. Glucose dehydrogenase nicotinamide adenine

3. Glucose oxidase, or glucose

komposisi darah arteri dibandingkan darah vena

sampling technique) dan perubahan aliran darah

 Korelasi yang cukup bagus antara kadar glukosa kapiler

 Kadar glukosa sample darah vena whole blood 7% lebih

 Pada saat kondisi puasa, kadar glukosa darah kapiler

 Namun saat pasien diberikan glukosa (glucose loading)

 Konversi secara umum adalah kadar glukosa darah

 Penelitian lain menunjukkan rentang perbedaan

• certain concentration levels

Maltose • Glucose dehydrogenase

• Low hematocrit values 

• High Dose Ascorbic Acid

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

Volume • Volume sampel yang tidak

Penyimpanan • Reagen sangat peka thd

• Daya batere yang tidak adekuat

Teknik • Kit must be insert properly  improperly

• Too much squeezing or 'milking' of the

Penyampaian • Transcription error/communication failure)

Device • Ikuti petunjuk

Quality • Reagen kontrol

a) achieving and c) avoiding (e) determining

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