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KIT DIAGNOSTIK

Dina Mulyanti,M.Si., Apt.

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PENDAHULUAN • DEFINISI KIT DIAGNOSTIK • DIAGNOSTIK MOLEKULAR – Diagnosa penyakit infeksi – Identifikasi genetik – Diagnosa penyakit genetik • DIAGNOSTIK NON MOLEKULAR – Senyawa kimia – Kehamilan 2 .

Kelebihan kit diagnostik • Menentukan diagnosa penyakit dengan segera • Penegakan diagnosa • Menentukan status klinis seseorang • Penghematan waktu • Penggunaan spesimen dalam jumlah kecil 3 .

Kekurangan kit diagnostik • Biaya • Keterbatasan jumlah galur bakteri/virus • Bergantung pada teknologi tinggi 4 .

Diagnosa Penyakit Infeksi • Penyakit yang disebabkan oleh bakteri dan virus – Hepatitis – HIV – Typhus – Syphilis – TB – HPV 5 .

5% 3. (HIV C10-20): 1) Type: Cassette 2) Specimen: Serum/plasma 3) Package: 1pc x 40/kit 5) Sensitivity: 2NCU/ml 6) Specificity: >99.0mm 5) Sensitivity: 2NCU/ml 6) Specificity: >99. (HIV C10-11): 1) Type: Strip 2) Specimen: Serum/plasma 3) Package: 1pc x 40/kit 4) Specification: 3. Features 1. (HIV C10-21): 1) Type: cassette 2) Specimen: whole blood 3) Package: 1pc x 40/kit 5) Sensitivity: 2NCU/ml 6) Specificity: >99.5% 6 .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.5% 2.

Features: 1) TP C20-12: A) Type: Strip B) Specimen: Serum/plasma C) Package: 1pc x 100/kit D) Specification: 3.5mm E) Sensitivity: 2NCU/ml F) Specificity: >99% 7 .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.one step syphilis test strip • One step syphilis tester is a rapid direct binding screening tester for the presence of antibodies to syphilis.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.

Identifikasi Genetik • Paternity testing • Forensic 8 .

toxicity • cytochromes • Mutations in monogenic diseases 9 . Tyrosine kinase inhibitors – Drug efficacity .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.

Diagnosa senyawa kimia • • • • An immuno-chromatographic assay for rapid. MTD. MOP. AMP. MET. COC. 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 10 . BAR. KET Description: – – – – • High sensitivity Simple. MDMA. 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.

5. 4.0mm. 12.0mm E) Sensitivity: 300ng/ml F) Specificity: >99% 11 . fast. Features: 1) MOP D10-11. crisp.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.Product name: One step Morphine test strip Place of origin: China One Step Morphine Test strip. 13: A) Type: Strip B) Specimen: Urine C) Package: 1PC x 100/kit D) Specification: 3. Morphine urine test. easy to read reactions.

000ng/ml F) Specificity: >99% 2) MET D20-20: A) Type: Cassette B) Specimen: Urine C) Package: 1PC x 40/kit D) Specification: 3. 4. The cutoff concentration for this test is 1000 ng/ml 1) MET D20-11. 000ng/ml F) Specificity: >99% 12 . qualitative immunoassay for the detection of d-methamphetamine in urine.• Product name: One Step Methamphetamine Test Strip Place of origin: China The Methamphetamine Test is a one step rapid.0mm. 5.5mm E) Sensitivity: 1. 12. 13: A) Type: Strip B) Specimen: Urine C) Package: 1pcx 100/kit D) Specification: 3.0mm E) Sensitivity: 1.0mm.

4.• Product Name: One Step Amphetamine Test Strip Place of Origin: China Features: 1) AMP D70-11.0mm.5mm E) Sensitivity: 300ng/ml F) Specificity: >99% 13 . 5. 12. 13: A) Type: Strip B) Specimen: Urine C) Package: 1PC x 100/kit D) Specification: 3.0mm.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.

qualitative immunoassay for the detection of beonzoylecgonine. in urine. 12. 13: A) Type: Strip B) Specimen: Urine C) Package: 1PC x 100/kit D) Specification: 3.• Product name: ( COC) One Step Cocaine Test Strip Place of origin: China The Cocaine test is a one step rapid. 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. The cutoff concentration for this test is 300 ng/ml Features: 1) COC D30-11.5mm E) Sensitivity: 300ng/ml F) Specificity: >99% 14 .0mm. a hydrolytic degradation product.0mm. 4.

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: >99.0mm E) Sensitivity: 25mIU/ml F) Specificity: >99.5% 15 .5% 6) HCG A10-30: A) Type: Midstream B) Specimen: Urine C) Package: 1pc x 40/kit D) Specification: 6.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.5mm E) Sensitivity: 25mIU/ml F) Specificity: >99. Features: 1) HCG A10-11: A) Type: Strip B) Specimen: Urine C) Package: 1pc x 100/kit D) Specification: 2.

Teknologi • Reaksi Antigen Antibodi (Imunologi) – ELISA • Reaksi Enzimatik • Sekuensing DNA • MIP (Molecular Imprinted polymer) 16 .