JPWO2021016602A5 - - Google Patents
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- JPWO2021016602A5 JPWO2021016602A5 JP2022504572A JP2022504572A JPWO2021016602A5 JP WO2021016602 A5 JPWO2021016602 A5 JP WO2021016602A5 JP 2022504572 A JP2022504572 A JP 2022504572A JP 2022504572 A JP2022504572 A JP 2022504572A JP WO2021016602 A5 JPWO2021016602 A5 JP WO2021016602A5
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Description
一部の実施形態では、本発明は、配列番号1~76に対して、少なくとも90%、少なくとも95%、少なくとも96%、少なくとも97%、少なくとも98%、少なくとも99%%、少なくとも99.1%、少なくとも99.2%、少なくとも99.3%、少なくとも99.4%、少なくとも99.5%、少なくとも99.6%、少なくとも99.7%、少なくとも99.8%、または少なくとも99.9%が同一である核酸配列、及び、それらの核酸を使用して、試験試料中のナイセリア・ゴノレアを検出する方法を提供する。
[本発明1001]
セット-1~セット-15からなる群から選択される配列特異的プライマーセットを含む、組成物。
[本発明1002]
前記配列特異的プライマーセットが、セット-5、セット-11、セット-13、セット-14、及びセット-15からなる群から選択される、本発明1001の組成物。
[本発明1003]
前記配列特異的プライマーセットがセット-15である、本発明1002の方法。
[本発明1004]
プローブをさらに含む、本発明1001の組成物。
[本発明1005]
前記プローブが標識を含む、本発明1004の組成物。
[本発明1006]
前記プローブが、標識されたポリヌクレオチドである、本発明1005の組成物。
[本発明1007]
前記標識されたポリヌクレオチドが、配列番号73のヌクレオチド6~22、配列番号74のヌクレオチド5~24、配列番号75のヌクレオチド3~21、及び配列番号76のヌクレオチド3~24からなる群から選択される配列を含む、本発明1006の組成物。
[本発明1008]
前記標識されたポリヌクレオチドが、配列番号73~配列番号76からなる群から選択される配列を含む、本発明1006の組成物。
[本発明1009]
前記標識がフルオロフォアである、本発明1006の組成物。
[本発明1010]
前記フルオロフォアが、前記ポリヌクレオチドの末端に共有結合している、本発明1009の組成物。
[本発明1011]
前記プローブが、フルオロフォアとクエンチャーとポリヌクレオチドとを含む分子ビーコンである、本発明1004の組成物。
[本発明1012]
前記分子ビーコンが、配列番号73~配列番号76からなる群から選択される配列を含む、本発明1011の組成物。
[本発明1013]
ポリヌクレオチド配列が配列番号75からなる、本発明1012の組成物。
[本発明1014]
以下を含む、試験試料中のナイセリア・ゴノレア(Neisseria gonorrhoeae)を検出する方法:
前記試験試料から核酸を抽出すること;
ステップ(a)で抽出した核酸を、鎖置換DNAポリメラーゼと配列特異的プライマーセットとを含む反応混合物と反応させることによって、標的配列を増幅することであって、前記配列特異的プライマーセットが、セット-1~セット-15からなる群から選択される、前記増幅すること;及び
ステップ(b)の増幅産物の有無を検出することであって、前記増幅産物の存在が、前記試験試料中のナイセリア・ゴノレアの存在を示す、前記検出すること。
[本発明1015]
増幅ステップが15分未満の間行われる、本発明1014の方法。
[本発明1016]
増幅ステップが10分未満の間行われる、本発明1014の方法。
[本発明1017]
前記反応混合物が逆転写酵素をさらに含む、本発明1014の方法。
[本発明1018]
前記増幅産物の有無を検出することが、前記増幅産物を、標識に結合しているポリヌクレオチドを含むプローブとハイブリダイズさせることを含む、本発明1014の方法。
[本発明1019]
標識された前記ポリヌクレオチドが、配列番号73のヌクレオチド6~22、配列番号74のヌクレオチド5~24、配列番号75のヌクレオチド3~21、及び配列番号76のヌクレオチド3~24からなる群から選択される配列を含む、本発明1018の方法。
[本発明1020]
標識された前記ポリヌクレオチドが、配列番号73~配列番号76からなる群から選択される配列を含む、本発明1019の方法。
[本発明1021]
前記配列特異的プライマーセットが、セット-5、セット-11、セット-13、セット-14、及びセット-15からなる群から選択される、本発明1014の方法。
[本発明1022]
前記配列特異的プライマーセットがセット-15である、本発明1021の方法。
[本発明1023]
ナイセリア・ゴノレアが、≦100CFU/mLの濃度で前記試験試料に存在する、本発明1014の方法。
[本発明1024]
ナイセリア・ゴノレアが、≦10CFU/mLの濃度で試験試料に存在する、本発明1023の方法。
[本発明1025]
ナイセリア・ゴノレアが、≦10CFU/mLの濃度で前記試験試料に存在し、かつ、増幅反応が15分未満の間行われる、本発明1024の方法。
[本発明1026]
本発明1001の組成物を含む、キット。
[本発明1027]
鎖置換ポリメラーゼをさらに含む、本発明1026のキット。
[本発明1028]
逆転写酵素をさらに含む、本発明1027のキット。
In some embodiments, the present invention provides at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, at least 99%, at least 99.1% , at least 99.2%, at least 99.3%, at least 99.4%, at least 99.5%, at least 99.6%, at least 99.7%, at least 99.8%, or at least 99.9% Nucleic acid sequences that are identical and methods of using those nucleic acids to detect Neisseria gonorrhoeae in test samples are provided.
[Invention 1001]
A composition comprising a sequence-specific primer set selected from the group consisting of set-1 through set-15.
[Invention 1002]
1001. The composition of the present invention 1001, wherein said sequence-specific primer set is selected from the group consisting of set-5, set-11, set-13, set-14, and set-15.
[Invention 1003]
1002. The method of the invention 1002, wherein said sequence-specific primer set is set-15.
[Invention 1004]
The composition of the invention 1001, further comprising a probe.
[Invention 1005]
The composition of invention 1004, wherein said probe comprises a label.
[Invention 1006]
The composition of invention 1005, wherein said probe is a labeled polynucleotide.
[Invention 1007]
said labeled polynucleotide is selected from the group consisting of nucleotides 6-22 of SEQ ID NO:73, nucleotides 5-24 of SEQ ID NO:74, nucleotides 3-21 of SEQ ID NO:75, and nucleotides 3-24 of SEQ ID NO:76. The composition of the invention 1006, comprising the sequence
[Invention 1008]
1006. The composition of the invention 1006, wherein said labeled polynucleotide comprises a sequence selected from the group consisting of SEQ ID NO:73-SEQ ID NO:76.
[Invention 1009]
The composition of invention 1006, wherein said label is a fluorophore.
[Invention 1010]
1009. The composition of invention 1009, wherein said fluorophore is covalently attached to the terminus of said polynucleotide.
[Invention 1011]
The composition of invention 1004, wherein said probe is a molecular beacon comprising a fluorophore, a quencher and a polynucleotide.
[Invention 1012]
1011. The composition of the invention 1011, wherein said molecular beacon comprises a sequence selected from the group consisting of SEQ ID NO:73-SEQ ID NO:76.
[Invention 1013]
1012. The composition of the invention 1012, wherein the polynucleotide sequence consists of SEQ ID NO:75.
[Invention 1014]
A method of detecting Neisseria gonorrhoeae in a test sample comprising:
extracting nucleic acids from the test sample;
Amplifying a target sequence by reacting the nucleic acid extracted in step (a) with a reaction mixture comprising a strand-displacing DNA polymerase and a sequence-specific primer set, wherein the sequence-specific primer set said amplifying selected from the group consisting of -1 to set-15; and
detecting the presence or absence of the amplification product of step (b), wherein the presence of said amplification product indicates the presence of Neisseria gonorrhoeae in said test sample.
[Invention 1015]
1014. The method of the invention 1014, wherein the amplification step is performed for less than 15 minutes.
[Invention 1016]
1014. The method of the invention 1014, wherein the amplification step is performed for less than 10 minutes.
[Invention 1017]
1015. The method of invention 1014, wherein said reaction mixture further comprises reverse transcriptase.
[Invention 1018]
1015. The method of invention 1014, wherein detecting the presence or absence of said amplification product comprises hybridizing said amplification product with a probe comprising a polynucleotide bound to a label.
[Invention 1019]
said labeled polynucleotide is selected from the group consisting of nucleotides 6-22 of SEQ ID NO:73, nucleotides 5-24 of SEQ ID NO:74, nucleotides 3-21 of SEQ ID NO:75, and nucleotides 3-24 of SEQ ID NO:76. The method of the invention 1018, comprising the sequence
[Invention 1020]
The method of invention 1019, wherein said labeled polynucleotide comprises a sequence selected from the group consisting of SEQ ID NO:73-SEQ ID NO:76.
[Invention 1021]
1015. The method of the invention 1014, wherein said sequence-specific primer set is selected from the group consisting of Set-5, Set-11, Set-13, Set-14, and Set-15.
[Invention 1022]
1021. The method of the invention 1021, wherein said sequence-specific primer set is set-15.
[Invention 1023]
1015. The method of invention 1014, wherein Neisseria gonorrhoeae is present in said test sample at a concentration of < 100 CFU/mL.
[Invention 1024]
1023. The method of invention 1023, wherein Neisseria gonorrhoeae is present in the test sample at a concentration of ≦10 CFU/mL.
[Invention 1025]
1024. The method of the invention 1024, wherein Neisseria gonorrhoeae is present in said test sample at a concentration of ≦10 CFU/mL and the amplification reaction is conducted for less than 15 minutes.
[Invention 1026]
A kit comprising the composition of the invention 1001.
[Invention 1027]
The kit of the invention 1026, further comprising a strand displacement polymerase.
[Invention 1028]
The kit of the invention 1027, further comprising reverse transcriptase.
Claims (28)
(a)前記試験試料から核酸を抽出すること;
(b)ステップ(a)で抽出した核酸を、鎖置換DNAポリメラーゼと配列特異的プライマーセットとを含む反応混合物と反応させることによって、標的配列を増幅することであって、前記配列特異的プライマーセットが、セット-15及びセット-1~セット-14からなる群から選択される、前記増幅すること;及び
(c)ステップ(b)の増幅産物の有無を検出することであって、前記増幅産物の存在が、前記試験試料中のナイセリア・ゴノレアの存在を示す、前記検出すること。 A method of detecting Neisseria gonorrhoeae in a test sample comprising:
(a) extracting nucleic acids from said test sample;
(b) amplifying the target sequence by reacting the nucleic acid extracted in step (a) with a reaction mixture comprising a strand-displacing DNA polymerase and a sequence-specific primer set, said sequence-specific primer set; is selected from the group consisting of Set -15 and Set-1 through Set-14 ; and
(c) detecting the presence or absence of the amplification product of step (b), wherein the presence of said amplification product indicates the presence of Neisseria gonorrhoeae in said test sample;
Applications Claiming Priority (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201962878639P | 2019-07-25 | 2019-07-25 | |
US62/878,639 | 2019-07-25 | ||
US201916523609A | 2019-07-26 | 2019-07-26 | |
US16/523,609 | 2019-07-26 | ||
US16/719,744 | 2019-12-18 | ||
US16/719,744 US10954572B2 (en) | 2019-07-25 | 2019-12-18 | Polynucleotides for the amplification and detection of Neisseria gonorrhoeae |
PCT/US2020/043620 WO2021016602A1 (en) | 2019-07-25 | 2020-07-24 | Polynucleotides for the amplification and detection of neisseria gonorrhoeae |
Publications (2)
Publication Number | Publication Date |
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JP2022542361A JP2022542361A (en) | 2022-10-03 |
JPWO2021016602A5 true JPWO2021016602A5 (en) | 2023-07-28 |
Family
ID=74190742
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2022504572A Pending JP2022542361A (en) | 2019-07-25 | 2020-07-24 | Polynucleotides for amplification and detection of Neisseria gonorrhoeae |
Country Status (14)
Country | Link |
---|---|
US (1) | US10954572B2 (en) |
EP (1) | EP4004014A4 (en) |
JP (1) | JP2022542361A (en) |
KR (1) | KR20220044760A (en) |
CN (1) | CN114502747A (en) |
AU (1) | AU2020315931A1 (en) |
BR (1) | BR112022001038A2 (en) |
CA (1) | CA3147244A1 (en) |
CL (1) | CL2022000126A1 (en) |
CO (1) | CO2022001223A2 (en) |
IL (1) | IL289461A (en) |
JO (1) | JOP20220004A1 (en) |
MX (1) | MX2022000907A (en) |
WO (1) | WO2021016602A1 (en) |
Families Citing this family (3)
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US11891662B2 (en) | 2019-12-02 | 2024-02-06 | Talis Biomedical Corporation | Polynucleotides for amplification and detection of human beta actin |
PL437280A1 (en) * | 2021-03-12 | 2022-09-19 | Genomtec Spółka Akcyjna | Amplification primer set, method for detecting a sexually transmitted bacterial infection, and infection detection kit |
WO2023023601A1 (en) * | 2021-08-18 | 2023-02-23 | Talis Biomedical Corporation | Polynucleotides for the amplification and detection of influenza a |
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-
2019
- 2019-12-18 US US16/719,744 patent/US10954572B2/en active Active
-
2020
- 2020-07-24 CN CN202080053433.7A patent/CN114502747A/en active Pending
- 2020-07-24 JP JP2022504572A patent/JP2022542361A/en active Pending
- 2020-07-24 CA CA3147244A patent/CA3147244A1/en active Pending
- 2020-07-24 MX MX2022000907A patent/MX2022000907A/en unknown
- 2020-07-24 BR BR112022001038A patent/BR112022001038A2/en unknown
- 2020-07-24 KR KR1020227006359A patent/KR20220044760A/en unknown
- 2020-07-24 EP EP20843271.6A patent/EP4004014A4/en active Pending
- 2020-07-24 AU AU2020315931A patent/AU2020315931A1/en active Pending
- 2020-07-24 WO PCT/US2020/043620 patent/WO2021016602A1/en active Application Filing
- 2020-07-24 JO JOP/2022/0004A patent/JOP20220004A1/en unknown
-
2021
- 2021-12-28 IL IL289461A patent/IL289461A/en unknown
-
2022
- 2022-01-19 CL CL2022000126A patent/CL2022000126A1/en unknown
- 2022-02-07 CO CONC2022/0001223A patent/CO2022001223A2/en unknown
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