KIT DIAGNOSTIK

Dina Mulyanti,M.Si., Apt.

PENDAHULUAN
DEFINISI KIT DIAGNOSTIK
DIAGNOSTIK MOLEKULAR
Diagnosa penyakit infeksi
Identifikasi genetik
Diagnosa penyakit genetik

DIAGNOSTIK NON MOLEKULAR

Senyawa kimia
Kehamilan
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Kelebihan kit diagnostik

Menentukan diagnosa penyakit dengan
segera
Penegakan diagnosa
Menentukan status klinis seseorang
Penghematan waktu
Penggunaan spesimen dalam jumlah kecil

Kekurangan kit diagnostik

Biaya
Keterbatasan jumlah galur bakteri/virus
Bergantung pada teknologi tinggi

Diagnosa Penyakit Infeksi

Penyakit yang disebabkan oleh bakteri
dan virus
Hepatitis
HIV
Typhus
Syphilis
TB
HPV
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HIV 1+2

One step anti-HIV 1 + 2 tester is a rapid direct binding screening tester for the presence of
antibodies to HIV1 and HIV2 viruses.
Features
1. (HIV C10-11):
1) Type: Strip
2) Specimen: Serum/plasma
3) Package: 1pc x 40/kit
4) Specification: 3.0mm
5) Sensitivity: 2NCU/ml
6) Specificity: >99.5%
2. (HIV C10-21):
1) Type: cassette
2) Specimen: whole blood
3) Package: 1pc x 40/kit
5) Sensitivity: 2NCU/ml
6) Specificity: >99.5%
3. (HIV C10-20):
1) Type: Cassette
2) Specimen: Serum/plasma
3) Package: 1pc x 40/kit
5) Sensitivity: 2NCU/ml
6) Specificity: >99.5%

one step syphilis test strip

One step syphilis tester is a rapid direct binding screening tester for the presence of antibodies to
syphilis.
Features:
1) TP C20-12:
A) Type: Strip
B) Specimen: Serum/plasma
C) Package: 1pc x 100/kit
D) Specification: 3.0mm
E) Sensitivity: 2NCU/ml
F) Specificity: >99%
2) TP C20-13:
A) Type: Strip
B) Specimen: Serum/plasma
C) Package: 1pc x 100/kit
D) Specification: 4.0mm
E) Sensitivity: 2NCU/ml
F) Specificity: >99%
4) TP: C20-20
A) Type: Cassette
B) Specimen: Serum/plasma
C) Package: 1pc x 40/kit
D) Specification: 3.5mm
E) Sensitivity: 2NCU/ml
F) Specificity: >99%

Identifikasi Genetik
Paternity testing
Forensic

Diagnosa penyakit genetik

Somatic rearrangements in cancer

Chromosomal breaks produce fusion genes

These cause leukemias and lymphomas
Diagnosis determines treatment and prognosis

Genetic risk factors

Monogenic diseases are caused by a deleterious mutation in a single
gene: Disease-causing mutations
Multifactorial diseases are caused by a combination of variations in
multiple genes: Genetic Risk Factors

Deep venous thrombosis

Cardiovascular disease
Alzheimer disease
Osteoporosis

Pharmacogenetics
Drug specificity
HER2, Tyrosine kinase inhibitors

Drug efficacity - toxicity

cytochromes

Mutations in monogenic diseases

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Diagnosa senyawa kimia

An immuno-chromatographic assay for rapid, qualitative detection of drugs

and their principal metabolites in urine at specified cut off concentrations
Employs unique mixture of monoclonal and polyclonal antibodies to selectively
identify drugs of abuse and their metabolites in test samples with a high
degree of sensitivity
Tests for the following chemicals: THC, MET, COC, MDMA, MOP, MTD, AMP,
BAR, KET
Description:

High sensitivity
Simple, easy and accurate
Built-in control system
Can read results at 5 minutes

Format
Strip Format
Lowest cost test format
Device Format
Most commonly used test format
Panel Format
Convenient format for multi-drug screening
May be any combination of 2-9 drug tests

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Product name: One step Morphine test strip

Place of origin: China
One Step Morphine Test strip. Morphine urine test, fast, crisp,
easy to read reactions.
Features:
1) MOP D10-11, 12, 13:
A) Type: Strip
B) Specimen: Urine
C) Package: 1PC x 100/kit
D) Specification: 3.0mm, 4.0mm, 5.0mm
E) Sensitivity: 300ng/ml
F) Specificity: >99%
2) MOP D10-20:
A) Type: Cassette
B) Specimen: Urine
C) Package: 1PC x 40/kit
D) Specification: 4.0mm
E) Sensitivity: 300ng/ml
F) Specificity: >99%

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 Product name: One Step Methamphetamine Test Strip

Place of origin: China
The Methamphetamine Test is a one step rapid, qualitative
immunoassay for the detection of d-methamphetamine in urine. The
cutoff concentration for this test is 1000 ng/ml
1) MET D20-11, 12, 13:
A) Type: Strip
B) Specimen: Urine
C) Package: 1pcx 100/kit
D) Specification: 3.0mm, 4.0mm, 5.0mm
E) Sensitivity: 1, 000ng/ml
F) Specificity: >99%
2) MET D20-20:
A) Type: Cassette
B) Specimen: Urine
C) Package: 1PC x 40/kit
D) Specification: 3.5mm
E) Sensitivity: 1, 000ng/ml
F) Specificity: >99%
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Product Name: One Step Amphetamine Test Strip

Place of Origin: China
Features:
1) AMP D70-11, 12, 13:
A) Type: Strip
B) Specimen: Urine
C) Package: 1PC x 100/kit
D) Specification: 3.0mm, 4.0mm, 5.0mm
E) Sensitivity: 300ng/ml
F) Specificity: >99%
2) AMP D70-20:
A) Type: Cassette
B) Specimen: Urine
C) Package: 1PC x 40/kit
D) Specification: 3.5mm
E) Sensitivity: 300ng/ml
F) Specificity: >99%

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Product name: ( COC) One Step Cocaine Test Strip

Place of origin: China
The Cocaine test is a one step rapid, qualitative immunoassay for
the detection of beonzoylecgonine, a hydrolytic degradation product,
in urine. The cutoff concentration for this test is 300 ng/ml
Features:
1) COC D30-11, 12, 13:
A) Type: Strip
B) Specimen: Urine
C) Package: 1PC x 100/kit
D) Specification: 3.0mm, 4.0mm, 5.0mm
E) Sensitivity: 300ng/ml
F) Specificity: >99%
2) COC D30-20
A) Type: Cassette
B) Specimen: Urine
C) Package: 1PC x 40/kit
D) Specification: 3.5mm
E) Sensitivity: 300ng/ml
F) Specificity: >99%
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Diagnosa Kehamilan

Product Name: HCG Test

Place of Origin: China
One step HCG pregnancy test is a self-performing immunoassay designed for the qualitative
determination of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy
by visual within 5 minutes.
Features:
1) HCG A10-11:
A) Type: Strip
B) Specimen: Urine
C) Package: 1pc x 100/kit
D) Specification: 2.5mm
E) Sensitivity: 25mIU/ml
F) Specificity: >99.5%
5) HCG A10-20:
A) Type: Cassette
B) Specimen: Urine
C) Package: 1pc x 40/kit
D) Specification: 4mm
E) Sensitivity: 25mIU/ml
F) Specificity: >99.5%
6) HCG A10-30:
A) Type: Midstream
B) Specimen: Urine
C) Package: 1pc x 40/kit
D) Specification: 6.0mm
E) Sensitivity: 25mIU/ml
F) Specificity: >99.5%

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Teknologi
Reaksi Antigen Antibodi (Imunologi)
ELISA

Reaksi Enzimatik
Sekuensing DNA
MIP (Molecular Imprinted polymer)

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