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Figure 1. Sequence diagram of Novodiag and communication with LIS using the low-level protocol.
Figure 2. Sequence diagram of Amplidiag Analyzer and communication with LIS using the low-level protocol.
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H|@^\|||NOVODIAG^COMPUTERNAME^123456789001^2000000001|||||TestHost||P|
LIS02-A2|20200604180000
P|1
O|1|Example1||^^^CV|R|00010101000000
R|1|^^^CV^COVID-19^2.0.0^18001002|NEGATIVE|||||F||Admin|20200604162148|
00010101000000|2000000001
R|2|^^^CORONAE^^^SARS-CoV-2 (E)|NEGATIVE
R|3|^^^CORONAN^^^SARS-CoV-2 (N)|NEGATIVE
L|1|N
H|@^\|||NOVODIAG^COMPUTERNAME^123456789001^2000000002|||||TestHost||P|
LIS02-A2|20200604180000
P|1
O|1|Example2||^^^CV|R|00010101000000
R|1|^^^CV^COVID-19^2.0.0^18001002|POSITIVE|||||F||Admin|20200604160000|
20200604164500|2000000002
R|2|^^^CORONAE^^^SARS-CoV-2 (E)|POSITIVE
R|3|^^^CORONAN^^^SARS-CoV-2 (N)|POSITIVE
L|1|N
H|@^\|||NOVODIAG^COMPUTERNAME^123456789001^2000000003|||||TestHost||P|
LIS02-A2|20200604180000
P|1
O|1|Example3||^^^CV|R|00010101000000
R|1|^^^CV^COVID-19^2.0.0^18001002|INVALID|||||F||Admin|20200604164742|
00010101000000|2000000003
C|1|I|Sampling control failed, no result available.|G
R|2|^^^CORONAE^^^SARS-CoV-2 (E)|INVALID
R|3|^^^CORONAN^^^SARS-CoV-2 (N)|INVALID
L|1|N
H|@^\|||NOVODIAG^ComputerName^123456789001^1194928656|||||TestHost||P|LIS02-
A2|20201110171044
P|1
O|1|SampleName||^^^RP4|R|00010101000000
R|1|^^^RP4^RESP-
4^1.0^11113291|POSITIVE|||||F||OperatorName|20201110140026|20201110140047|119
4928656
R|2|^^^INFA^^^Influenza A virus|POSITIVE
R|3|^^^INFB^^^Influenza B virus|NEGATIVE
R|4|^^^RSVAB^^^Respiratory syncytial virus A/B|NEGATIVE
R|5|^^^CORONAE^^^SARS-CoV-2 (E)|NEGATIVE
R|6|^^^CORONAN^^^SARS-CoV-2 (N)|NEGATIVE
L|1|N
H|@^\|||NOVODIAG^COMPUTERNAME^123456789001^2000000000|||||TestHost||P|
LIS02-A2|20200605132512
P|1
O|1|Example4||^^^BG|R|00010101000000
R|1|^^^BG^Bacterial GE+^2.0.2^11113291|POSITIVE|||||F||Admin|20200605132141|
00010101000000|2000000000
R|2|^^^CCOLI^^^Campylobacter coli|NEGATIVE
R|3|^^^CJEJUNI^^^Campylobacter jejuni|NEGATIVE
R|4|^^^CDIFFB^^^Clostridium difficile toxin B|NEGATIVE
R|5|^^^EAEC^^^EAEC|NEGATIVE
R|6|^^^EHEC6^^^EHEC (eae, stx1, stx2)|POSITIVE
C|1|I|Possibility of O157 serotype|P
R|7|^^^EPEC^^^EPEC (eae)|N/A
C|1|I|EPEC cannot be ruled out|P
R|8|^^^ETEC^^^ETEC|NEGATIVE
R|9|^^^SALMSPP^^^Salmonella spp.|NEGATIVE
R|10|^^^SHISPP^^^Shigella spp./EIEC|NEGATIVE
R|11|^^^VCHOL^^^Vibrio cholerae|NEGATIVE
R|12|^^^VPARA^^^Vibrio parahaemolyticus|POSITIVE
R|13|^^^YENTERO^^^Yersinia enterocolitica|NEGATIVE
R|14|^^^YPSEUDOT^^^Yersinia pseudotuberculosis/pestis|NEGATIVE
L|1|N
H|@^\|||NOVODIAG^COMPUTERNAME^123456789001^2000000001|||||TestHost||P|
LIS02-A2|20200605133615
P|1
O|1|Example5||^^^BG|R|00010101000000
R|1|^^^BG^Bacterial GE+^2.0.2^11113291|INVALID|||||F||Admin|20200605133455|
00010101000000|2000000001
C|1|I|Internal control failed, no result available. Rerun or dilute sample.|G
R|2|^^^CCOLI^^^Campylobacter coli|INVALID
R|3|^^^CJEJUNI^^^Campylobacter jejuni|INVALID
R|4|^^^CDIFFB^^^Clostridium difficile toxin B|INVALID
R|5|^^^EAEC^^^EAEC|INVALID
R|6|^^^EHEC3^^^EHEC (stx1, stx2)|INVALID
R|7|^^^EPEC^^^EPEC (eae)|INVALID
R|8|^^^ETEC^^^ETEC|INVALID
R|9|^^^SALMSPP^^^Salmonella spp.|INVALID
R|10|^^^SHISPP^^^Shigella spp./EIEC|INVALID
R|11|^^^VCHOL^^^Vibrio cholerae|INVALID
R|12|^^^VPARA^^^Vibrio parahaemolyticus|INVALID
R|13|^^^YENTERO^^^Yersinia enterocolitica|INVALID
R|14|^^^YPSEUDOT^^^Yersinia pseudotuberculosis/pestis|INVALID
L|1|N
H|@^\|||NOVODIAG^ComputerName^123456789001^2194928656|||||TestHost||P|LIS02-
A2|20201214182339
P|1
O|1|PositiveSample||^^^SP|R|00010101000000
R|1|^^^SP^Stool
Parasites^1.0.0^11113292|POSITIVE|||||F||OperatorName|20201214135659|20201214
135756|2194928656
R|2|^^^ANCYLO^^^Ancylostoma duodenale|NEGATIVE
R|3|^^^ASCARIS^^^Ascaris lumbricoides / suum|NEGATIVE
R|4|^^^BALANTI^^^Balantidium coli|NEGATIVE
R|5|^^^BLASTO^^^Blastocystis spp.|POSITIVE
R|6|^^^CLONORC^^^Clonorchis sinensis / Opisthorchis spp. / Metorchis
spp.|NEGATIVE
R|7|^^^CRYPTO^^^Cryptosporidium spp.|NEGATIVE
R|8|^^^CYCLO^^^Cyclospora cayetanensis|NEGATIVE
R|9|^^^CYSTOBEL^^^Cystoisospora belli|NEGATIVE
R|10|^^^DIENTAM^^^Dientamoeba fragilis|NEGATIVE
R|11|^^^DIPHYLL^^^Diphyllobothrium latum / nihonkaiense|NEGATIVE
R|12|^^^ENCEPHA^^^Encephalitozoon spp.|NEGATIVE
R|13|^^^ENTAM^^^Entamoeba histolytica|NEGATIVE
R|14|^^^ENTVER^^^Enterobius vermicularis|NEGATIVE
R|15|^^^ENTBIE^^^Enterocytozoon bieneusi|NEGATIVE
R|16|^^^FASCSPP^^^Fasciola spp.|NEGATIVE
R|17|^^^FASCBUS^^^Fasciolopsis buski|NEGATIVE
R|18|^^^GIARDIA^^^Giardia intestinalis|NEGATIVE
R|19|^^^HYMDIMI^^^Hymenolepis diminuta|NEGATIVE
R|20|^^^HYMNANA^^^Hymenolepis nana|NEGATIVE
R|21|^^^NECATOR^^^Necator americanus|NEGATIVE
R|22|^^^SCHIMAN^^^Schistosoma mansoni|POSITIVE
R|23|^^^SCHISPP^^^Schistosoma spp.|N/A
C|1|I|Other Schistosoma spp. cannot be ruled out|P
R|24|^^^STRONGY^^^Strongyloides stercoralis|NEGATIVE
R|25|^^^TAESAG^^^Taenia saginata / asiatica|NEGATIVE
R|26|^^^TAESOL^^^Taenia solium|NEGATIVE
R|27|^^^TRICHUR^^^Trichuris spp.|NEGATIVE
L|1|N
H|@^\|||NOVODIAG^ComputerName^123456789001^2094928656|||||TestHost||P|LIS02-
A2|20201214182936
P|1
O|1|NegativeSample||^^^SP|R|00010101000000
R|1|^^^SP^Stool
Parasites^1.0.0^11113292|NEGATIVE|||||F||OperatorName|20201214135644|20201214
135814|2094928656
R|2|^^^ANCYLO^^^Ancylostoma duodenale|NEGATIVE
R|3|^^^ASCARIS^^^Ascaris lumbricoides / suum|NEGATIVE
R|4|^^^BALANTI^^^Balantidium coli|NEGATIVE
R|5|^^^BLASTO^^^Blastocystis spp.|NEGATIVE
R|6|^^^CLONORC^^^Clonorchis sinensis / Opisthorchis spp. / Metorchis
spp.|NEGATIVE
R|7|^^^CRYPTO^^^Cryptosporidium spp.|NEGATIVE
R|8|^^^CYCLO^^^Cyclospora cayetanensis|NEGATIVE
R|9|^^^CYSTOBEL^^^Cystoisospora belli|NEGATIVE
R|10|^^^DIENTAM^^^Dientamoeba fragilis|NEGATIVE
R|11|^^^DIPHYLL^^^Diphyllobothrium latum / nihonkaiense|NEGATIVE
R|12|^^^ENCEPHA^^^Encephalitozoon spp.|NEGATIVE
R|13|^^^ENTAM^^^Entamoeba histolytica|NEGATIVE
R|14|^^^ENTVER^^^Enterobius vermicularis|NEGATIVE
R|15|^^^ENTBIE^^^Enterocytozoon bieneusi|NEGATIVE
R|16|^^^FASCSPP^^^Fasciola spp.|NEGATIVE
R|17|^^^FASCBUS^^^Fasciolopsis buski|NEGATIVE
R|18|^^^GIARDIA^^^Giardia intestinalis|NEGATIVE
R|19|^^^HYMDIMI^^^Hymenolepis diminuta|NEGATIVE
R|20|^^^HYMNANA^^^Hymenolepis nana|NEGATIVE
R|21|^^^NECATOR^^^Necator americanus|NEGATIVE
R|22|^^^SCHIMAN^^^Schistosoma mansoni|NEGATIVE
R|23|^^^SCHISPP^^^Schistosoma spp.|NEGATIVE
R|24|^^^STRONGY^^^Strongyloides stercoralis|NEGATIVE
R|25|^^^TAESAG^^^Taenia saginata / asiatica|NEGATIVE
R|26|^^^TAESOL^^^Taenia solium|NEGATIVE
R|27|^^^TRICHUR^^^Trichuris spp.|NEGATIVE
L|1|N
H|@^\|||NOVODIAG^ComputerName^123456789001^2294928656|||||TestHost||P|LIS02-
A2|20201214183018
P|1
O|1|InvalidSample||^^^SP|R|00010101000000
R|1|^^^SP^Stool
Parasites^1.0.0^11113292|INVALID|||||F||OperatorName|20201214135606|202012141
35806|2294928656
C|1|I|Internal control failed, no result available. Rerun or dilute sample.|G
R|2|^^^ANCYLO^^^Ancylostoma duodenale|INVALID
R|3|^^^ASCARIS^^^Ascaris lumbricoides / suum|INVALID
R|4|^^^BALANTI^^^Balantidium coli|INVALID
R|5|^^^BLASTO^^^Blastocystis spp.|INVALID
R|6|^^^CLONORC^^^Clonorchis sinensis / Opisthorchis spp. / Metorchis
spp.|INVALID
R|7|^^^CRYPTO^^^Cryptosporidium spp.|INVALID
R|8|^^^CYCLO^^^Cyclospora cayetanensis|INVALID
R|9|^^^CYSTOBEL^^^Cystoisospora belli|INVALID
R|10|^^^DIENTAM^^^Dientamoeba fragilis|INVALID
R|11|^^^DIPHYLL^^^Diphyllobothrium latum / nihonkaiense|INVALID
R|12|^^^ENCEPHA^^^Encephalitozoon spp.|INVALID
R|13|^^^ENTAM^^^Entamoeba histolytica|INVALID
R|14|^^^ENTVER^^^Enterobius vermicularis|INVALID
R|15|^^^ENTBIE^^^Enterocytozoon bieneusi|INVALID
R|16|^^^FASCSPP^^^Fasciola spp.|INVALID
R|17|^^^FASCBUS^^^Fasciolopsis buski|INVALID
R|18|^^^GIARDIA^^^Giardia intestinalis|INVALID
R|19|^^^HYMDIMI^^^Hymenolepis diminuta|INVALID
R|20|^^^HYMNANA^^^Hymenolepis nana|INVALID
R|21|^^^NECATOR^^^Necator americanus|INVALID
R|22|^^^SCHIMAN^^^Schistosoma mansoni|INVALID
R|23|^^^SCHISPP^^^Schistosoma spp.|INVALID
R|24|^^^STRONGY^^^Strongyloides stercoralis|INVALID
R|25|^^^TAESAG^^^Taenia saginata / asiatica|INVALID
R|26|^^^TAESOL^^^Taenia solium|INVALID
R|27|^^^TRICHUR^^^Trichuris spp.|INVALID
L|1|N
H|@^\|||AMPLIDIAG^COMPUTER-NAME^BR102325^COVID-CFX|||||TestHost||P|
LIS02-A2|20200409114100
P|1
O|1|Sample1||^^^AD-CV|R|00010101000000
R|1|^^^AD-CV^COVID-19^2-0^|POSITIVE|||||F||OperatorName|20200407171517|
20200407171517|COVID-CFX
R|2|^^^CORONAN^^^SARS-CoV-2 (N)|POSITIVE
R|3|^^^CORONAORF1AB^^^SARS-CoV-2 (orf1ab)|NEGATIVE
P|2
O|1|Sample2||^^^AD-CV|R|00010101000000
R|1|^^^AD-CV^COVID-19^2-0^|NEGATIVE|||||F||OperatorName|20200407171517|
20200407171517|COVID-CFX
R|2|^^^CORONAN^^^SARS-CoV-2 (N)|NEGATIVE
R|3|^^^CORONAORF1AB^^^SARS-CoV-2 (orf1ab)|NEGATIVE
L|1|N
H|@^\|||AMPLIDIAG^ComputerName^BR123456^Resp4|||||TestHost||P|LIS02-
A2|20201216145458
P|1
O|1|FailingSample||^^^AD-RP4|R|00010101000000
R|1|^^^AD-RP4^RESP-4^1-
0^|INVALID|||||F||OperatorName|20201116170041|20201116170041|Resp4
C|1|I|Warning: [A7-SC] Sampling Control just within range|G
C|2|I|Error: [A7-PRC] Process Control out of range|G
C|3|I|Error: [A8-PRC] Process Control out of range|G
R|2|^^^CORONAN^^^SARS-CoV-2 (N)|INVALID
R|3|^^^CORONAE^^^SARS-CoV-2 (E)|INVALID
R|4|^^^INFA^^^Influenza A|INVALID
R|5|^^^INFB^^^Influenza B|INVALID
R|6|^^^RSVAB^^^RSV A/B|INVALID
P|2
O|1|PositiveSample||^^^AD-RP4|R|00010101000000
R|1|^^^AD-RP4^RESP-4^1-
0^|POSITIVE|||||F||OperatorName|20201116170041|20201116170041|Resp4
R|2|^^^CORONAN^^^SARS-CoV-2 (N)|NEGATIVE
R|3|^^^CORONAE^^^SARS-CoV-2 (E)|POSITIVE
R|4|^^^INFA^^^Influenza A|NEGATIVE
R|5|^^^INFB^^^Influenza B|NEGATIVE
R|6|^^^RSVAB^^^RSV A/B|NEGATIVE
P|3
O|1|NegativeWithWarning||^^^AD-RP4|R|00010101000000
R|1|^^^AD-RP4^RESP-4^1-
0^|NEGATIVE|||||F||OperatorName|20201116170041|20201116170041|Resp4
C|1|I|Warning: [C7-SC] Sampling Control just within range|G
R|2|^^^CORONAN^^^SARS-CoV-2 (N)|NEGATIVE
R|3|^^^CORONAE^^^SARS-CoV-2 (E)|NEGATIVE
R|4|^^^INFA^^^Influenza A|NEGATIVE
R|5|^^^INFB^^^Influenza B|NEGATIVE
R|6|^^^RSVAB^^^RSV A/B|NEGATIVE
P|4
O|1|NegativeSample||^^^AD-RP4|R|00010101000000
R|1|^^^AD-RP4^RESP-4^1-
0^|NEGATIVE|||||F||OperatorName|20201116170041|20201116170041|Resp4
R|2|^^^CORONAN^^^SARS-CoV-2 (N)|NEGATIVE
R|3|^^^CORONAE^^^SARS-CoV-2 (E)|NEGATIVE
R|4|^^^INFA^^^Influenza A|NEGATIVE
R|5|^^^INFB^^^Influenza B|NEGATIVE
R|6|^^^RSVAB^^^RSV A/B|NEGATIVE
L|1|N
H|@^\|||^Host^|||||Novodiag||P|1394-97|20180912100245
P|1|||10542154|Einstein^Albert
O|1|Sample001||^^^BG|R|20180912091554
O|2|Sample002||^^^CD|R|20180912091558
P|2|||10742164|Smith^Harry
O|1|Sample003||^^^CD|R|20180912091602
L|1|N
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00 NUL 10 DLE 20 SP 30 0 40 @ 50 P 60 ` 70 p
01 SOH 11 DC1 21 ! 31 1 41 A 51 Q 61 a 71 q
02 STX 12 DC2 22 “ 32 2 42 B 52 R 62 b 72 r
03 ETX 13 DC3 23 # 33 3 43 C 53 S 63 c 73 s
04 EOT 14 DC4 24 $ 34 4 44 D 54 T 64 d 74 t
05 ENQ 15 NAK 25 % 35 5 45 E 55 U 65 e 75 u
06 ACK 16 SYN 26 & 36 6 46 F 56 V 66 f 76 v
07 BEL 17 ETB 27 ‘ 37 7 47 G 57 W 67 g 77 w
08 BS 18 CAN 28 ( 38 8 48 H 58 X 68 h 78 x
09 HT 19 EM 29 ) 39 9 49 I 59 Y 69 i 79 y
0A LF 1A SUB 2A * 3A : 4A J 5A Z 6A j 7A z
0B VT 1B ESC 2B + 3B ; 4B K 5B [ 6B k 7B {
0C FF 1C FS 2C , 3C < 4C L 5C \ 6C l 7C |
0D CR 1D GS 2D - 3D = 4D M 5D ] 6D m 7D }
0E SO 1E RS 2E . 3E > 4E N 5E ^ 6E n 7E ~
0F SI 1F US 2F / 3F ? 4F O 5F _ 6F o 7F DEL