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Instrument R&D Department SD BIOSENSOR ​COMPANY CONFIDENTIAL

Appendex I

Table of Observation Items

Type Short Name Long Name Unit Specimen LOIN LOIN LOINC DESC
(for F100 C CD C
Analyzer) Sub
ID

Qualitati RSV Respiratory Syncytial nominal Nasopharyngeal 7739 1.0.0. Respiratory syncytial virus Ag [Presence] in
ve Virus Swab 0-3 1 Nasopharynx by Immunofluorescence
Nasopharyngeal
Aspirate
Nasopharyngeal
Wash

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CWE Flu A+B Influenza A+B nominal Nasal Swab 7236 1.0.0. Influenza virus A and B Ag [Identifier] in Nose by
Nasopharyngeal 5-0 2 Immunofluorescence
Swab
Nasopharyngeal https://r.details.loinc.org/AnswerList/LL2214-6.ht
Aspirate ml
Nasopharyngeal 1 Influenza A virus positive LA19017-5
Wash 2 Influenza A virus negative LA19018-3
3 Influenza B virus positive LA19019-1
4 Influenza B virus negative LA19020-9
5 Procedure control valid LA19021-7
6 Procedure control invalid LA19022-5

Qualitati Strep A Group A Streptococcus nominal Throat swab 6557 1.0.0. Streptococcus pyogenes Ag [Presence] in
ve -3 3 Throat by Immunofluorescence

Qualitati Legionella Legionella pneumophila nominal Urine 1705 1.0.0. Legionella pneumophila Ag [Presence] in Urine
ve (L. pneumophila) 9-7 4 by Immunofluorescence

Qualitati S.pneumo Streptococcus nominal Urine 6553 1.0.0. Streptococcus pneumoniae Ag [Presence] in
ve pneumoniae Cerebrospinal -2 5 Unspecified specimen by Immunofluorescence
Fluid (CSF)

​Quantita HbA1c Hemoglobin A1c NGSP(% whole blood 4548 1.0.0. Hemoglobin A1c/Hemoglobin.total in Blood
tive ) -4 7 Hemoglobin A1c/Hemoglobin.total in Blood by
IFCC(mm 5926 IFCC protocol
ol/mol) 1-8 Hemoglobin A1c/Hemoglobin.total in Blood by
JDS(%) 6238 JDS/JSCC protocol
mono-S( 8-4
%)

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​Quantita CRP C-reactive Protein mg/L whole blood, 4842 1.0.0. C reactive protein [Mass/​volume] in Capillary
tive Serum, Plasma 1-2 32 blood
1988 C reactive protein [Mass/​volume] in Serum or
-5 Plasma

​Quantita U-ALB Microalbumin mg/L Urine 1495 1.0.0. Microalbumin [Mass/volume] in Urine
tive 7-5 8

​Quantita PCT Procalcitonin ng/ml Serum, plasma 3395 1.0.0. Procalcitonin [Mass/​volume] in Serum or
tive 9-8 9 Plasma

​Quantita Vit. D Vitamin D ng/ml Serum 3536 1.0.0. Vitamin D+​Metabolites [Mass/​volume] in Serum
tive 5-6 10 or Plasma

​Quantita CK-MB creatne kinase MB ng/mL serum 1396 1.0.0. Creatine kinase.MB [Mass/volume] in serum or
tive 9-1 22 plasma

whole blood 4955 Creatine kinase.MB [Mass/volume] in blood


1-5

​Quantita D-Dimer D-dimer ng/mL plasma, whole 7142 1.0.0. D-dimer is elevated in disseminated
tive FEU blood 7-9 31 intravascular coagulation (DIC), deep vein
thrombosis (DVT), and pulmonary embolism
(PE).

​Quantita cTnI cardiac Troponin I ng/mL serum 1083 1.0.0. Troponin I.cardiac [Mass/volume] in serum or
tive 9-9 21 plasma

whole blood 4275 Troponin I.cardiac [Mass/volume] in Blood


7-5

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​Quantita hsCRP high sensitivity mg/L serum, whole 3052 1.0.0. C-reactive protein (CRP) is characterized by its
tive C-reactive protein blood 2-7 24 precipitation by the C-fraction of pneumococci.
This protein is an acute phase reactant and
confers immunity against some bacterial
infections. CRP is a sensitive and quantitative
measurement of the body's acute-phase
response. Elevated values are consistent with
an acute inflammatory process such as a
bacterial infection or rheumatic disease.

​Quantita iFOB fecal occult blood ng/mL stool 8037 1.0.0. Hemoglobin.gastrointestinal [Presence] in Stool
tive 2-6 39 by Rapid immunoassay

​Quantita PSA Prostate specific Ag ng/mL Serum/Plasma 2857 1.0.0. Prostate-specific antigen is a glycoprotein and in
tive [Mass/volume] -1 34 the blood.
in Serum or Plasma PSA complexed with the serine protease
inhibitor or alpha-1-antichymotrypsin,

​Quantita TSH Thyrotropin μIU/mL Serum 3016 1.0.0. Thyroid-stimulating hormone ( TSH or
tive [Units/volume] in Serum -3 25 thyrotropin) is a hormone synthesized and
or Plasma secreted by thyrotrope cells in the anterior
pituitary gland. It regulates the endocrine
function of the thyroid gland.

CWE Dengue Dengue IgM/IgG nominal Ser/Plas/Bld 7522 1.0.0. Dengue virus IgG and IgM [Identifier] in Serum,
IgM/IgG 3-8 15 Plasma or Blood by Rapid immunoassay

1 SDB75223-8-1 IgM
2 SDB75223-8-2 IgG

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Qualitati Dengue Ag Dengue NS1 Ag nominal Ser/Plas/Bld 7537 1.0.0. Dengue virus NS1 Ag [Presence] in Serum,
ve 7-2 12 Plasma or Blood by Rapid immunoassay

Qualitati HCV Ab Hepatitis C virus Ab nominal Serum, Plasma 7237 1.0.0. Hepatitis C virus (HCV) is a small (50 nm in
ve [Presence] or Blood 6-7 20 size), enveloped, single-stranded,
in Serum, Plasma or positive sense RNA virus in the genus
Blood hepacivirus,
by Rapid immunoassay which is in the Flaviviridae family.

CWE Rota/Adeno Rotavirus and nominal Stool 1.0.0. Rotavirus and Adenovirus Ag panel - Stool by
Adenovirus Ag 8037 29 Rapid immunoassay
6-7
https://r.details.loinc.org/AnswerList/LL2021-5.ht
ml
1 Rotavirus Positive LA6576-8
2 Rotavirus Negative LA6577-6
3 Rotavirus Invalid LA15841-2

https://r.details.loinc.org/AnswerList/LL2021-5.ht
ml
1 Adenovirus Positive LA6576-8
2 Adenovirus Negative LA6577-6
3 Adenovirus Invalid LA15841-2

Qualitati Rota Ag Rotavirus Ag nominal Stool 7217 1.0.0. Rotavirus Ag [Presence] in Stool by Rapid
ve 4-6 27 immunoassay

​Quantita LH LH mlU/mL Serum/Plasma 1050 1.0.0. Lutropin [Units/​volume] in Serum or Plasma


tive 1-5 33

whole blood SDB- Lutropin [Units/​volume] in whole blood

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0330

​Quantita Beta-hCG Beta human chorionic mlU/mL Serum 2041 1.0.0. Human chorionic gonadotropin, beta subunit
tive gonadotropin 5-6 19 [Units/​volume] in serum or plasma by
Immunoassay (EIA) 3rd IS

whole blood SDB- Human chorionic gonadotropin, beta subunit


0190 [Units/​volume] in whole blood by Immunoassay
(EIA) 3rd IS

​Quantita PCT(Whole procalcitonin ng/mL serum/plasma 3395 1.0.0. Procalcitonin [Mass/​volume] in Serum or
tive blood) 9-8 26 Plasma

CWE Zika Zika IgM/IgG nominal Se/Plas/Bld SDB- 1.0.0. Zika virus IgM and IgG AB [Identifier] in Serum
IgM/IgG 0160 16 or plasma or whole blood by
Immunofluorescence
1 SDB0160-1 IgM
2 SDB0160-2 IgG

Qualitati Zika Ag Zika Ag nominal Se/Plas/Bld SDB- 1.0.0. Zika virus NS1 and ENV Ag [Presence] in
ve 0130 13 Serum, Plasma or Blood by Rapid
immunoassay

CWE Chikunguya Chikungunya IgM/IgG nominal Se/Plas/Bld SDB- 1.0.0. Chikungunya virus IgM and IgG Ab [Presence]
IgM/IgG 0170 17 in Serum or Plasma or whole blood by
Immunofluorescence
1 SDB0170-1 IgM
2 SDB0170-2 IgG

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